Aspira Women's Health Inc (AWH) 2015 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the second-quarter 2015 Vermillion earnings conference call. My name is Chanel and I will be your coordinator for the call today. With me today are Valerie Palmieri, President and Chief Executive Officer of Vermillion; Eric Schoen, the Company's Vice President of Finance and Chief Accounting Officer; Dr. Donald Munroe, Senior Vice President of Business Development and Chief Scientific Officer; and Laura Miller, Senior Vice President of Sales and Customer Experience. This afternoon, they will recap their Q2 2015 performance and discuss progress on 2015 priorities.

Before we get started, I would like to point out that there will be a replay of this conference call available via telephone and Internet. Please refer to today's press release for replay information.

Some of the commentary and answers to today's questions may contain forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements. Vermillion is providing this information as of the date of this conference call, and does not undertake any obligation to update any forward-looking statements contained on this call as a result of new information, future events, or otherwise.

Forward-looking statements reflect management's current estimates, projections, expectations or beliefs, and involve risk and uncertainties that could cause actual results and outcomes to be materially different. Risk and uncertainties that may affect the future results of the Company include, but are not limited to: the competitive environment, the speed of market adoption, changes in government regulations, payer reimbursement, relationships with our strategic partners, and other factors as described in the Vermillion 2014 Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.

Following the Vermillion team's remarks, we will open up the call for your questions.

Now I would like to turn the call over to Ms. Palmieri.

Thank you, Chanel. Good afternoon, everyone, and welcome. Today we will be discussing our Q2 milestones which mark Vermillion's continued progress in 2015.

These milestones include the following: an update on our overall strategic plan; a review of our Q2 financials, including an update on our ASPiRA Labs sales and payer progress; an update on the status of our OVA2 FDA regulatory submission. We will also review the details regarding the approval of a $7.5 million grant to fund the majority of our registry; and lastly, the result of our public offering of common stock to fund an ongoing investment in the business for the long term.

Let me first start with our strategic plan. As mentioned on prior earnings calls, our strategic plan has three phases: our rebuild phase, which started in late 2014, and is now very close to completion; a transformation phase, which began in January 2015 and will continue through early 2016; and last, a market expansion and growth phase which will demonstrate meaningful results in 2016 and beyond.

Let me first address our rebuild phase. This phase lays the foundation for the deployment of our new strategy. The most significant milestone of this phase is our new testing and services agreement with Quest.

I am happy to report that as of this week, August 10, 100% of the Quest testing volume from all 50 states have been transferred to our wholly owned subsidiary, ASPiRA Labs. As previously reported, we can only accept 39 states. But with the receipt of our last and most difficult license, New York State, we are now able to transfer 100% of all OVA1 testing to ASPiRA.

This is truly an historic moment for the Company, as the planning of this achievement started two years ago. With ASPiRA Labs now performing 100% of the testing of OVA1 specimens nationally, we own the entire customer and patient experience while maintaining the Quest logistics infrastructure for the customers' ease of use. Laura Miller, our Senior Vice President of Sales and Customer Experience, will elaborate on this later in the call.

Our second milestone is the completion and deployment of our ASPiRA commercialization team. We have spent the quarter filling the remainder of the roles we detailed on the last earnings call, in addition to increasing our penetration in specific markets, with significant growth in new accounts and kit delivery.

One additional point: with our new, non-exclusive commercial agreement with Quest, ASPiRA is now free to enter in agreements with other large, regional lab players and expand OVA1's reach beyond the current Quest customer base. Laura will also discuss our commercial progress later in the call.

I am now going to move on to our second phase of our strategy, which is the transformation phase. This phase changes our focus from solely being a technology license Company to a high-performing diagnostic service Company through ASPiRA Labs. This phase includes five major milestones, of which I will discuss four in detail.

First, the submission and clearance of our next-generation product, OVA2, plus an overview of our new OVA2 data from the recent ASCO meeting. Second, the continued development and publication of a strong health economic foundation with several studies in the works. Third, the implementation of regional and national care pathway protocols, including SGO, NCCN, and ACOG guidelines. Fourth, the initiation of a first-in-kind public match registry to develop our gynecologic disease portfolio. And finally, planning for international launch in late 2016.

In terms of the first milestone, the submission and clearance of our second-generation OVA2 product, the FDA submission continues to pace toward a targeted launch of OVA2 in the second half of 2015. We were very pleased with the two presentations of OVA2 at the American Society of Clinical Oncology, better known as ASCO's annual meeting in May. The presentations reviewed the development of our product as well as the strong clinical validation of OVA2's performance. Dr. Donald Munroe, our Chief Scientific Officer and Senior Vice President of Business Development, will go into more depth on the regulatory path of OVA2, as well as the ASCO presentations in a few minutes.

Our second and third milestones include the design and development of health economic data in regional and national guidelines. We have just completed our first clinical utility study collecting necessary data to drive guidelines in medical policy. While the results have recently been compiled, early indications show the study has met its primary objective of demonstrating OVA1's effectiveness in clinical practice, as well as being a very important tool in the triage of pelvic masses and improving overall patient outcomes. The manuscript is being written, and we will be submitting for publication in a peer-reviewed journal. We look forward to sharing the positive results of the study in the near-term.

In addition to the study, we are continuing our health economic and value-based pricing march with three publications, which include completing a cost effectiveness study with our second-generation product OVA2; and two health economic studies, one with Kaiser Permanente and the second with a renowned NPCN center, Moffitt Cancer Center, which we will be publishing in 2016.

Our fourth milestone of this phase is the initiation of a first-of-its-kind public mass registry. Remember, we intend to use the data of this registry to develop predictive disease algorithms via the use of diagnostic markers, including genes, proteins, and other diagnostics, plus incorporating other modalities such as imaging, as well as physician and patient-reported clinical information.

The registry will develop enterprise assets, not just for the present focus in ovarian cancer, but will allow us to address the benign care pathway dilemmas for a very large potential market of 20 million patients, including women who have endometriosis, polycystic ovarian disease, and other gynecologic disease.

We will be initiating this registry as of Q4 2015. But we have received a very important catalyst, which is a product development grant from the Cancer Prevention and Research Institute of Texas, better known as CPRIT, for a total of $7.5 million. This competitive award will help facilitate establishment of the registry as well as allow us to use a portion of those funds that we have previously allocated to the registry to support other areas of the business, or reducing our overall burn rate. Please note the receipt of any CPRIT funds is subject to the successful negotiation of a contract between the parties, and may include the payment of future royalties to CPRIT by Vermillion.

Our last milestone is the building of our international foundation. In designing and developing OVA2, we intentionally put the product on a widely distributed platform, the Roche cobas 6000. The Roche platform has over 10,000 installs worldwide. OVA1 has already generated a high degree of interest, ex-US. So we believe OVA2 on the Roche platform has the ability to change the way pelvic mass disease is managed at the point of care on a global basis. We are already had the OVA1 CE Mark, and we will be submitting OVA2 for CE Mark later this year. We anticipate a late 2016 launch in specific international markets.

As we enter this transformation phase, I would also like to note that we have secured the financial footings to complete this phase and make significant progress to the next phase, which is global market expansion and growth. We closed on an $18.8 million public offering of common stock last month. Vermillion intends to use the proceeds to fuel our commercial, bioanalytics, and product development efforts, as well as move towards profitability.

This concludes my introduction, so let's now turn to the financials. I will hand the call over to Eric Schoen, our Chief Accounting Officer and Vice President of Finance, for a review of our Q2 financials.

Eric?

Thanks, Valerie. This morning, we filed our second-quarter 2015 financial results in a press release and our Form 10-Q with the Securities and Exchange Commission, which is available for download via the investors section of our website at www.vermillion.com.

Total product revenue in the second quarter of 2015 was $535,000 as compared to $211,000 in the same year-ago period. As a result of Vermillion's new commercial agreement with Quest Diagnostics on March 11, 2015, the Company now recognizes all product revenue at the time of OVA1 test is performed by Quest Diagnostics, rather than deferring some revenue, as in prior periods.

ASPiRA Labs revenue is being recognized on a cash basis; and, thus, there is a lag period between performing a test and being able to recognize ASPiRA revenue for that test. ASPiRA contributed $52,000 to revenue for the second quarter of 2015 compared to $26,000 in the first quarter of 2015. Product revenue in the second quarter of 2015 was derived from 4,103 OVA1 tests, which is consistent with the 4,223 OVA1 tests performed in the same year-ago quarter.

Volume in the second quarter of 2015 included 274 tests performed at ASPiRA Labs. The comparable ASPiRA volume in the first quarter of 2015 was 216 tests. While overall test volumes were flat compared to the prior year, we were pleased to see the bounce-back from the lower Q1 2015 total volume of 3,783 tests, representing an 8% quarter-over-quarter increase.

As we convert from a licensing company to a diagnostic services company, we are transitioning from receiving a small percentage of net revenue per patient, via a licensing fee, to receiving 100% of the revenue when ASPiRA is the billing entity. However, since we are a new billing entity, we initially expect a greater than 180-day delay on receiving most payments in parallel with building our contracted payer network. The payer contracts do not come over with the Quest specimens, so ASPiRA is in the process of obtaining its own payer contracts. Thus, we will experience a timing issue with recognizing revenue in the second half of 2015.

Cost of revenue in the second quarter of 2015 increased to $574,000 compared to $88,000 in the prior year. The increase related to the ongoing cost of operating ASPiRA Labs. ASPiRA Labs opened on June 23, 2014, so only included one week of costs in comparison to the prior-year quarter.

Operating expenses for the three months ended June 30, 2015, were approximately $4.8 million compared with operating expenses of $5.8 million for the same three-month period in 2014. The year-over-year decrease was due primarily to one-time items in 2014, including severance, ASPiRA Labs' pre-opening costs, and branding not being repeated in 2015.

Net loss for the second quarter was $4.8 million or $0.11 per share on weighted average shares outstanding of 43 million. This compares to a net loss of $5.6 million or $0.15 per share in the second quarter of 2014 on 35.9 million shares outstanding.

Cash and cash equivalents at June 30, 2015, were $10.9 million. The Company utilized $5.1 million in cash in the second quarter of 2015, and paid an additional $1.3 million to repurchase common stock. We repurchased 861,000 shares of common stock held by Quest Diagnostics in the second quarter at a negotiated price of $1.50 per share. Those shares have now been retired.

On July 17, 2015, we completed an underwritten public offering of 9.6 million shares of common stock, including 1.25 million shares sold pursuant to the full exercise of the underwriter's option to purchase additional shares, at a price to the public of $1.96 per share. This represented just a 4% discount from the last market closing price of $2.04 before the offering pricing. Net proceeds from the offering were approximately $17.5 million. This raise leaves us in a strong cash position, with over $27 million of cash on hand at the end of July 2015.

Now I will turn it back to Valerie.

Thanks, Eric. I would like to turn the call over to our Senior Vice President of Sales and Customer Experience, Laura Miller, to review our sales and managed market activities.

Laura?

Thanks, Valerie. Let me start with a review of our Q2 performance. Volume was flat. Total performance between Quest and ASPiRA Labs averaged about 64 patients per day in Q2. The total volume is down for the first half of the year: 8,040 in 2014 versus 7,886 in 2015. Our ASPiRA volume has had positive momentum, with 490 new patients within 2015.

Within the ASPiRA managed accounts, we grew accounts on average by 9%, Q1 2015 versus Q2 2015. The ASPiRA Labs sales team established 118 new accounts in Q2, versus 19 accounts in Q1. This also translated into an increase of kits released of 1,464 kits in Q1 versus 2,344 kits being released in Q2. These are early key indicators to activity and potential growth with new ordering physicians and sites.

The ASPiRA sales team and inside sales team began the initial phase of the Quest conversion in May. This initial conversion process was measured by establishing new accounts on the ASPiRA platforms in preparation for the August 10 cutover. We noted on our last quarterly call, and I want to repeat, that we expect some attrition of Quest clients during the conversion process, as we are focused on larger hospital systems and regional reference laboratories versus smaller accounts. We are continuing to see a softness in Quest volumes in Q3.

We expect this to be a bridging quarter with the transition. Over 5,025 distinct new accounts were set up in May and June. This conversion will provide ownership of the entire process of OVA1 management, from collection through report to billing and appeal. Although it is heavy lifting, ownership of the customer experience will ultimately result in improving the adoption of the test, truly educating the physicians on our negative predictive value story, and increasing the number of patients we impact.

During this conversion, the ASPiRA sales team educated customers on the conversion, conveyed the ASPiRA difference, understood referral targeting, and established action plans for account development. The largest volume driver within the Quest initiative is conversion of regional reference laboratories and large health network systems. Through this conversion, over 25 laboratory services agreements have been initiated with regional reference laboratories and hospital systems. These relationships are critical to ensure OVA1 is available to the physicians and patients associated with these organizations. This previously represented 40% of the Quest OVA1 volume.

In Q3, there will be efforts with these organizations on co-marketing, training, co-branding, development of interfaces, and establishing logistical processes. There are also 8 new contracts initiated with non-Quest regional labs or hospital system networks.

Within Q3, the ASPiRA sales team will establish relationships with the previously Quest-managed accounts and physicians. The Q3 focus is on the top 10 accounts by market, and our regional reference laboratory strategy for volume growth and increased utilization of OVA1. The combined team of managed markets and sales will execute regional impact and clinical utility studies for OVA2. The efforts will focus on positive medical policy coverage for the payers in the given market.

Regarding our work towards payer acceptance of OVA1, we have received positive coverage by a mainstream payer which we will be announcing shortly, in addition to positive coverage by Blue Cross/Blue Shield of Michigan announced in April, and OVA1's ongoing coverage through Medicare. Our major milestone in this area continues to be obtaining positive medical policies by one national payer by the end of 2015. We continue to track towards this milestone with positive trends in medical coverage with a variety of payers.

I will now turn it back to you, Valerie.

Thanks, Laura. Let's now review our regulatory progress on our second-generation test, OVA2, and presentation of performance data at ASCO.

I am now going to turn it over to Donald Munroe, our Chief Scientific Officer. Donald?

Thanks, Valerie. Last quarter, we told you about the forthcoming presentation of two posters on the development and validation of OVA2 at the American Society for Clinical Oncology, or ASCO. Today, I will summarize a few key highlights from the posters, then update you on our progress on the 510(k).

The first poster, presented by our collaborator Dr. Zhen Zhang of the Johns Hopkins Center for Biomarker Discovery Translation, described the design, development and analytical verification of the OVA2 algorithm. Based on preliminary feasibility work, seven IVD grade biomarker assays were evaluated on a single industry-leading IVD automation platform, the Roche cobas 6000.

After an extensive technical redesign effort, the OVA2 algorithm was finalized and locked for validation. The OVA2 panel includes three of the five OVA1 markers: the A125, lipoprotein A1, and transparent; as well as two new analytes: follicle-stimulating hormone, or FSH, and a second tumor antigen, HE4. Like OVA1, OVA2 measures risk on a 0 to 10 scale. But it features a single cutoff of 5.0, irrespective of menopausal status. As a result, running an interpretation of the test is greatly simplified.

The second post reported on performance of OVA2 using germ samples from the OVA 500 cohort, a 493-patient intended use study of OVA1 published in 2013. The new biomarker panel was run at Johns Hopkins, and the OVA2 algorithm and statistical analyses were completed by an independent clinical statistician. Specificity in positive predictive value were significantly increased for OVA2 compared with OVA1 across all subjects, with 69% specificity and a 40% positive predictive value. This difference represents a 33% reduction in false positives and an overall 20% improvement in accuracy.

At the same time, sensitivity and negative predictive value were not significantly different than OVA1. And this extended to the detection of early-stage cancers, both in pre- and post-menopausal women. Those posters have been developed into manuscripts which are ready for submission this month. We will keep you posted on their publication, which is time to support the launch of OVA2. In fact, these will only be the first volley in a campaign of publications and podiums driving accelerated adoption, guidelines, and payment for OVA2, well into 2016.

So now let's turn into to the 510(k) progress report. The validation data, along with the comprehensive documentation package, were submitted as a 510(k) to FDA on March 6, as we told you previously. Then, in May, we began a series of information exchanges with FDA to address any questions FDA may have about the product, submission package, analytical or clinical validity, study design, or statistics.

While these exchanges have been going well, we continue to caution that the 510(k) process can never be taken for granted. New questions or requirements may arise at any point, which pose uncertainty to any clearance projections. However, we remain cautiously optimistic about receiving clearance in the second half of 2015, and will update you as things progress.

I will turn it back to Valerie now.

Thanks, Donald. In closing, we are pleased with our progress in the first half of 2015. Vermillion continues to hit or exceed on all planned milestone timelines we have set for ourselves. We are completing the rebuild phase and driving through the transformation phase of 2015 as we had planned.

In the second half of the year, we are well positioned for our third phase, which is market expansion and growth, in 2016. By this time we will expect to have completed the following. Number one, significant commercial traction with regional lab partners and large health network systems. Number two, a track record for value-based pricing, grounded in health economic data and acceptance by major national payers. Number three, fully exercise regional commercial strategies with our new OVA2 product. And last, the initiation of our sample and patient data registry, allowing us to develop new disease care pathway patterns to expand our product portfolio.

That concludes our presentation, and we are ready to take questions.

(Operator Instructions). Mark Massaro, Canaccord Genuity.

Thanks for taking the questions. Valerie, I was wondering if you could just maybe point to other products that you are seeing in the industry, where a product was taken back from a large reference lab. Are there any [precedents] that you can think of? And can you maybe identify what you think the key to do items are that would ensure minimal disruption as you make the transition?

Sure. So actually, Mark, it's funny that you asked that. So there is a case study which, while I was at LabCorp in a senior leadership position, there was a case study of EXACT Sciences where LabCorp was promoting the EXACT product (technical difficulty) have today. But nevertheless, what you had here was a large commodity business trying to promote a boutique product, trying to educate physicians on a -- I would call the physician a consultative sale, so almost a -- not a physician-to-physician sale, but an educated rep to a physician sale. And that product, as we know with LabCorp, did not do very well.

So EXACT reached a point, took the product back, and thus we have the EXACT story today. So, very similar. It's very difficult in terms of, I think, number one, the difference in the type of rep; the knowledge base of a rep, in terms of even the clinical status of the patient, and I'm going to say medical knowledge. But number two is really customizing that service.

So we anticipate -- similar to like a Myriad process -- in fact, we hired someone from Myriad to help us with this process. Just as Myriad indoctrinated a challenger model or physician protocol, we will be indoctrinating a process whereby we are part of an annual survey for the patient at the time of their annual exam. In terms of really understanding the true indicators of pelvic mass disease, what are those symptoms so we can dial it in -- so we are actually triaging those patients from the get-go, on an annual exam basis?

So number one is the sale in terms of having a consultive rep versus I am calling a menu taker. And number two is going to be what happens at that sale in terms of truly understanding our value proposition, and how to position a clinical solution.

Great. And maybe with respect to the regulatory conversations you are having with the FDA, at a high level would you characterize them as routine? And are there any things that they may be pushing back on that pose any material concern to you?

No. It has been -- the discussions have been very collegial. I'm actually -- it is one of the things, in terms of coming here as a new CEO, I am really amazed at the relationship that we have with the FDA. So it has been collegial. It has been more administrative, no surprises, nothing that we consider a high difficulty ratio. So as we said, we want to be cautious, because you never know with the FDA. But right now, things are smooth sailing.

Great. And I understand you cannot name the mainstream payer that you recently added. Could you share the number of lives on that payer?

Can we share the number of lives on that payer? I can tell you that they are a payer in a state which they control most of the lives in that state.

Okay. (multiple speakers) I'm sorry?

They are a major payer in a specific state where they control the majority of the lives.

Okay, great. And then as we think about some of the cost-effectiveness studies, you mentioned Kaiser and Moffat. What needs to happen for those studies to be published?

So, the Kaiser study is actually a three-phase study starting with a review of their current -- I am going to call it best practice or lack of best practice, which Kaiser is a closed environment as everyone knows. But the end product would be a pelvic mass score card or adnexal mass scorecard. So things are going actually quite well. And similar to the Moffitt study -- and, again, it is based on health economics -- but truly understanding where the patient is coming in through the care pathway process. And the data has actually been very tell-tale-ing.

And then also, how are they managing the patients? Because at the end of the day, and I am going to quote a Dr. Bristow article from 2013 in the New York Times, two-thirds of patients that have ovarian cancer, if they just got to the right doctor to begin with, they would have a standing chance. And it would be better than any pharmaceutical drug that they could take. So what we are seeing is we are seeing that replay with these studies, and we anticipate on getting some of the early results from these studies in 2016.

Great, and maybe a question for Eric. I think you used $5.1 million in cash in Q2. How do you see that progressing in the back half of this year?

Our base burn, Mark, is about $5 million a quarter. That is a good number. We will see it rise a bit because -- as we have more samples run through our lab; with the Quest transition, we are going to have more cost of sales. In addition, we won't be collecting revenue up front from Quest, as we have been doing. And lastly, we are going to be starting -- initiating the registry study, and typically what you do is you write a big check for some of your sites.

So five is a good number; certainly will not go above six in any quarter. But you can expect a bit of a rise in the back half of the year.

Excellent. And my last question and I will hop off; can you just remind us of your expectations for the size of your commercial force in the US?

What was that, Mark? I could not hear. Can you repeat that?

Yes, sorry. Can you just remind us your expectations on the size of your direct salesforce, and where you expect to be at the end of this year?

Sure. So we want to get to 25 in our salesforce. And that includes our reps that are calling on the GYN oncologist, the hospital groups, the regional reference labs; as well as an inside salesforce that calls on the OB/GYN. So about 25 in total.

Okay. Thanks very much, guys.

Debjit Chattopadhyay, ROTH Capital Partners.

Good afternoon, and thank you for taking the questions here. Let's start with the original plan of focusing on -- if I remember correctly, the Texas area, California, and the Upper Midwest. Is that still the areas of focus that you are planning for the second half, in terms of the commercial kind of launch?

So, that was our initial push in those regions. Part of that was where we saw existing customer bases, and I am going to say payer traction. And so if you look at our new account growth, that is where it has come from, the first half of the year. But as you can imagine in terms of just Metro populations -- Florida, New York, New Jersey -- so we intend to be getting us to that 25-person salesforce and building in those, I am going to call dense areas of the country.

So the volume that -- so if you compare the volume in the second quarter versus the volume last year, where was that primarily coming from? While you were under the Quest umbrella, that volume was what percent of the volume was from these three states -- Texas, California and the upper Midwest -- versus the rest of the country?

So when you look at the volumes, the majority of the volume is more Northeast-based. So in terms of where, because -- but keep in mind, we did not have a New York State license. So we could not focus on an area where we did not have a license; we could not perform the test. So if you look at where the volume is, it is based in the large metro areas.

If you look at where we were putting our reps in, it is where we had core volume and core payer penetration; that is where we put the reps initially. But in terms of going forward, we are going to be focusing on the larger states such as New York, New Jersey and, of course, Florida. But the initial push was those specific regions, and then going forward is going to be those larger metro areas.

Great. And the increase in price of OVA1, what is the feedback from the payers on that? What is your collection? You had 200-some-odd tests run through ASPiRA. I am just wondering what the collection was for that versus -- under Quest, you were getting about $130.

Yes, so what we are seeing is, for these tests that we have basically performed and build -- and, granted, we are very new into the process in terms of cycle time -- what we are seeing is an on average price of about $680. That is an average price with very highs, and then some are lower. But the average price is about $680 is what we are seeing. And those have been paid.

And even on our appeal rate, our appeal rates actually going better than we anticipated. But we are very early in the process. And that's why we are stating that when we take on this volume when we have a bolus, which actually just occurred on August 10, that is when we are really going to get a feel as to our true run rate on price, and also the DSO rate as well.

Great. And when you think about the cost of goods as ASPiRA comes up and running, what kind of volume do you need to see to turn, just from a gross perspective, to be profitable?

From a gross margin perspective, if we -- when we transfer all of the Quest volume over to ASPiRA and have it for a full quarter, we should be profitable on a gross margin basis, assuming we were collecting revenue and recognizing revenue on an accrual basis. With the cash basis of accounting, that will still be a couple quarters out.

Great. And any feedback from the current users on the data from OVA2? Post-ASCO, clearly people are aware of the data right now. And so any push-back prescribing or utilizing OVA1, or waiting up for OVA2 launch?

Yes. So I actually have some recent feedback. I was visiting a 200-man practice, and they have one GYN oncologist as part of this practice. So the feedback was, he did not think as highly of OVA1 because of the lack of specificity. And when we discussed the new specificity, the response was, this is a test that we think we can use. So it was actually in a conversation also with the CEO of the group of 200 physicians. And it led to follow-up discussions, where they want to actually get us into their care pathway process protocol, sooner than later.

So again, it is only one anecdote -- very large practice, but the feedback was very positive.

Thank you so much, and I will hop back in the queue.

(Operator Instructions). There are no further questions in the queue this time.

I would like to turn the conference over to Ms. Palmieri for any additional or closing remarks.

Thank you, Chanel. To conclude, we have a planned and methodical mission to change the course of pelvic mass disease in the US and worldwide. In 2015, we have two major phases to complete: our rebuild phase, and, in parallel, our transformation phase.

The two key elements are as follows: execution on our new commercial relationship with Quest, in which 100% of the volumes just transitioned this week; the successful deployment of our new commercialization strategy based on strong science and health economics to drive sales ramps, payer coverage, and value-based pricing. As we expand our market, we will be building upon our existing bioanalytic solutions platform to not only change the way ovarian cancer is managed, but by pushing early detection upstream and setting our sights on predictive analytics to manage pelvic mass diseases which impact one out of every five women.

Our end goal is to serve a large market with strong proprietary science on a global platform which will drive profitability and overall shareholder value.

Thank you for joining us today, and thank you for your interest in Vermillion. We look forward to seeing you at the upcoming medical meetings and investor conferences.

Again, I would like to remind everyone that this call will be available for replay through August 27, starting later this evening via the link provided in today's press release, as well as available in the investor section of the Company's website. Thank you, ladies and gentlemen, for joining us for today's presentation.