Aspira Women's Health Inc.

Aspira Women's Health Inc.

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Medical - Diagnostics & Research

Aspira Women's Health Inc. (AWH) Q1 2015 Earnings Call Transcript

Published at 2015-05-11 21:36:10
Executives
Valerie Palmieri – President and Chief Executive Officer Eric Schoen – Vice President, Finance and Chief Accounting Officer Laura Miller – Senior Vice President, Sales and Customer Experience Donald Munroe – Senior Vice President, Business Development and Chief Scientific Officer
Analysts
Debjit Chattopadhyay – ROTH Capital Markets John Grimley – TJW Capital Mark Macarro – Canaccord Genuity
Operator
Good day, ladies and gentlemen and welcome to the First Quarter 2015 Vermillion Earnings Conference Call. My mane is Rebecca and I’ll 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 and Chief Scientific Officer; and Laura Miller, Senior Vice President of Sales and Customer Experience. Today they will recap the Q1 2015 performance, discuss progress on the 2015 priorities. Before we get started, I would like to point out that there will be a replay of this conference 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 reflects management’s current estimates, projections, expectations or beliefs and involve risks and uncertainties that could cause actual results and outcomes fee materially different. Risks and uncertainties that may affect the future results of the company include, but are not limited to the competitive environments, 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. Please go ahead.
Valerie Palmieri
Thank you, Rebecca. Good morning, everyone and thank you for joining us today. Today we will be discussing the completion of several Q1 milestones which mark Vermillion deliberate and methodical progress in 2015. These milestones include the following. An update on our three stages of our strategic plan, a review of our Q1 financials, an update in our progress on commercial ramp, an update on the attraction we are being with payers, and exciting news on advances in health economics in OVA2 performance. First let me start with our strategic plan. As mentioned on the prior earnings call, our strategic plan includes three phases: number one, a rebuild phase, which started in late 2014, and will be complete in 2015; number two, a completion of our transformation phase in 2015, early 2016; and number three, a market expansion in growth phase through 2016. I am now going to address our rebuild phase. This phase includes the retooling of the management team and laying the foundation for the deployment of our new strategy. The rebuild phase is nearly complete and includes four major milestones. First and foremost is execution of our new commercial relationship with Quest. Second is finalizing our core senior management team. Third is completing the builds of our specialized ASPiRA Labs salesforce. And fourth is completing the builds of our managed markets team to drive payer acceptance with our OVA1 product. So first, in a series of gynecologic health products which will create best practice healthcare pathways for payers. I will be review each of these items in detail. We have made excellent progress in executing on one of the most significant milestones for the year, which is our detecting and services agreement with Quest. We’re actively working with Quest to transition testing in 49 states as of early June to ASPiRA Laboratory. Please note that this is 10 states more than the 39 we’d estimate at the time of Q4 earnings call. Due to that we see a specific state licenses by our laboratories. This is very significant as it allows us to capture the volume from these states, which is waiting until later in the year to capture the commercial value. So last state, that remains is the state of New York. And we now have an Inspection Day in June that we have long been waiting for. So that will be forthcoming. To recapture three key benefits at our new relationship with Quest: number one, we owned the customer experience from kit ordering through testing and billing. We’re building processes to significantly personalize the customer experience from a patient, physician and payer perspective. Number two, you will benefit as a business by performing the billing directly and capturing a 100% of the profit versus the life insurer relationship. And lastly, we’re partner with Quest to access the infrastructure to maintain the same ease of use process from a customer perspective. Very critical, this includes the use of Quest logistic systems with 2000 draw stations and 3,500 carriers. We will truly have the foundation to grow our portfolio with these customers and now we will have the ability to offer our portfolio outside of the Quest client base as well. Moving on to the second milestone, which is the investment in our core leadership team, we recently named Fred Ferrara to the newly-created post of Chief Information Officer. As we invest in transforming to a bioanalytics company, we need the right leadership to build and deliver our informatics products. Fred will focus on developing our diagnostic informatics platform while advancing access to our customers. He has numerous leadership roles in information technology and operations to such companies such as DIANON Systems, LabCorp and Aurora Diagnostics. Our 34th milestones for Phase 1 are solely focused on gaining traction in commercialization. These milestones include the creation of our new ASPiRA salesforce and the building of our new managed markets team with the rapid payer coverage. As we transition to a new commercial footing request our ASPiRA sales team has been trained and equipped to drive uptake across multiple call points including integrated delivery networks, ACOs, large OB/GYN practices and key influences such as gynecologic oncologists. Laura Miller, our Senior Vice President of Sales, will discuss in more depth our sales team structure and performance as well as how we have made substantial movement forward in payer acceptance for over one within the Blue Cross Blue Shield system. I'm now moving on to Phase 2 of our strategy, which is a transformation phase. This phase focuses on transitioning from being primarily a technology licensed company to a high performance diagnostic service company through ASPiRA Labs. This phase includes five major milestones for both companies. First, the submission and clearance of OVA2, second the development of a strong health economics foundation. Third the initiation of unparalleled public mass registry to drive our portfolio, fourth, the laying of the foundation for guidelines and fifth the investment in informatics team an infrastructure to deliver our portfolio. In terms of the first milestone the submission and clearance of our second generation of a two products Donald Munroe, our Chief Scientific Officer will review our progress in greater detail in a few minutes. The second crucial milestone for 2015 will be the publication of the health economic studies. The goal of this studies is to demonstrate to payers the impact OVA1 has on their members not just in terms of superior clinical outcomes, but the economic value of our test, just after our last earnings call we presented a landmark study on OVA1 cost effectiveness at the American College of Medical Quality better known as ACMQ. This health economic analysis of the OVA500 intended use trial data, examine the public map patient journey and healthcare class and outcomes while comparing patient care quality per unit versus commonly used triage diagnostics such as CA125 use and modify ACOG guidelines. We are very, very excited about the results and what they demonstrate for OVA1 clinical value in economics. You will hear more details in Donald’s overview. Building upon our health economic study we’ve also announced a new strategic partnership with Kaiser Permanente. The goal of this relationship is to create a best-practice care pathway for the diagnosis and treatment of ovarian cancer. This unprecedented collaboration will start to identify a best-in-class pathway for identification and appropriate treatment of ovarian malignancy. In later phases, this collaboration were about to evaluate the role that innovative diagnostics such as OVA1 and a successive test made play in better serving patients via optimizing healthcare delivery systems. Donald who will also be reviewing these developments in detail later in the discussion. Our third milestone in this phase, as it previously announced initiation of the unparalleled public mass registry. What make this registry unique is first that will be the first and only perspective clinical archive of its kind for multi-product data mining, bio market discovery and development. Second, this clinical research will develop enterprise assets not just ovarian cancer, but it cost a well-known confusing metrics of gynecologic diseases that present very similarly and affect millions of women each year. And third, the registry will file the patient journey for the timely first prevent with the public mass through diagnose this treatment in early outcomes. This help us potential for prognostic and predicted products and build hard data to support value driven product design positioning in commercialization. This study was set by on the care pathway dilemmas of a very large potential market of 20 million patients. 20% of all women in the U.S. is 20 to 70 years old have endometriosis polycystic ovarian disease or other gynecologic conditions today. One additional plan study is that will be designed with input not only from nationally renowned physicians. But also patient efficacy groups, health economists and community practitioners. We have made excellent progress on the recruitment of national key opinion leaders for gathering the data. We’ve convened few advisory boards of eminent researchers recently at the annual meetings of the Society of Gynecologic Oncologists and the American Congress of Obstetricians and Gynecologists better known as SGO and ACOG. These advisory boards helps us to identify the following. Number one a key clinical on health economic problems we need to solve, the creation of a master design for the registry as well as the recruitment of likely member institutions. We’re very, very encouraged by the enthusiasm of each group for the registry and with the valuable feedback on optimizing the predicted outcomes of the registry. We still foresee beginning enrollment of these patients in the registry in Q4 of this year. Our fourth milestone is a guideline plan. As you know, guidelines can take many years to achieve. We’re focused on leveraging a positive OVA1 physician statement, which was issued by SGO in 2013 with OVA2. In addition in 2015, we’ll turn our attention to guideline creation by ACOG and we will submit an updated package to NCCN. The last and final milestone for 2015, include the building of our informatics infrastructure, as well as infrastructure to access the international market, our goal is to build the informatics structure which will serve all three customer groups physicians, payers and most of our patients. Patients especially women drive health care in the U.S, and we intend to deliver system to ensure optimized customer experience. In terms of our international foundation, Vermillion is bolstering its infrastructure to commercialize globally and is actively accessing short-term and long-term opportunities, which will be core to our international plan, this will begin to show through in late 2016. This wraps up my introduction we will now move to the financials. I would like to turn the call over to Eric Schoen, our VP of Finance for review of our Q1 2015 financials. Eric?
Eric Schoen
Thanks, Valerie. Today, we filed our first quarter 2015 financial results in the press release, and will file our Form 10-K will with the Securities and Exchange Commission this week. These will be available for download via the Investors section of our website at www.vermillion.com. Total revenue for the first quarter of 2015 increased to $951,000 compared to $305,000 in the first quarter of 2014. Total revenue in the first quarter of 2015 included $635,000 from product sales of OVA1 and $316,000 of license revenue. Product revenue in the first quarter of 2015, was derived from 3,783 OVA1 tests performed, which was consistent with the 3,817 OVA1 test performed in the same period in the prior year. Volume in the first quarter of 2015 includes 216 tests performed at ASPiRA Labs, Vermillion's wholly owned national CLIA-certified laboratory. As discussed on the year-end earnings call, winter related weather and seasonality impacted test volumes in the first quarter of 2015, due to doctors and hospitals been closed 10% to 25% at the time depending on specific regions. We are however experiencing a bounce back in test volumes in the second quarter compared to the first quarter. As a result of our March 11, 2015, agreement with Quest Diagnostics, the company is now able to recognize all product revenue at the time an OVA1 test is performed by Quest Diagnostics rather then differing the variable portion of the revenue as weather practice in prior years. However, product revenue for the first quarter also included the one-time recognition of $163,000 of deferred revenue from Quest Diagnostics which represents the final deferred royalty recognition under the parties’ prior agreement. Cost of revenue in the first quarter of 2015 increased to $491,000 compared to $55,000 in the prior year due to costs associated with ASPiRA Labs which opened in June 2014. there were no comparables ASPiRA Labs expenses in the prior year quarter. Operating expenses for the three months ended March 31, 2015 were approximately $4.7 million, compared with operating expenses of $4.2 million for the same three months period in 2014. The year-over-year increase was due primarily to increases in personnel cost as we added key employees to further our strategy increased legal expenses and cost associated with billing for tax performed by ASPiRA LABS. Net loss for the first quarter was $4.1 million or $0.10 per share and weighted average shares outstanding of 43.1 million, this compares to a net loss of $4 million or a $0.11 per share in the first quarter of 2014 on 35.8 million shares outstanding. Cash and cash equivalents at March 31, 2015 was $17.2 million. The company utilized $4.5 million in cash in operations in the first quarter as well as the $1.1 million for the repayment of short-term debt. The company has no remaining debt as of March 31, 2015. Now, I’ll turn it back to Valerie.
Valerie Palmieri
Thanks, Eric. And now I’d 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?
Laura Miller
Thanks, Valerie. Let me start with the review of our Q1 performance. Volume was flat, the impact of the harsh winter as with other laboratory was most significant in geographical areas, where we have a strong present in the Northeast and Great Lakes market. Our ASPiRA volume has had positive momentum. In 2014, our sales team was a contracted salesforce. Our newly hired salesforce was hired and training was completed in Q1 2015. The entire sales team has been deployed and supported [indiscernible] for coverage in hospital systems and network, accountable sales organization, integrated delivery networks, the gynecological oncologists and OB/GYN call point. We are confident. We have the right strategy and right talent for the sales effectiveness in 2015. For Q2, we have also rounded at our commercialization process with insights sales account managers and a medical science liaisons. These team members are focused on whitespace, low touch call point and Quest conversion. This is the unique channel strategy in diagnostics and affords multiple touch point of customer contacts. The medical science liaison will support the sales function and key opinion leader development medical affairs, payer relation and physician provider education. The Quest conversion will began in June of 2015. This conversion will provide ownership of the entire process of OVA1 management from collection to report to billing and appeal, the entire customer experience we managed by the ASPiRA team. The most significant volume impact will be in the regional laboratory, focused on women’s help. We had significant momentum with regional lab negotiation through the Quest volume conversion. We should expect some attrition of clients during the conversion. The goal is to convert each Quest account to an ASPiRA account, within understanding and strategy of the conversion, ASPiRA different and growth goals with each accounts no later than early June. Regarding our initiative toward payer acceptance of OVA1, in Q1 we received positive medical coverage policy from Blue Cross Blue Shield of Michigan. This is significant as the Michigan region is one of the top volume producing regions for ASPiRA Labs. The positive coverage of Blue Cross Blue Shield of Michigan will greatly open up patient and provider access to OVA1. Blue Cross Blue Shield of Michigan, is the largest insurer in Michigan and joint other regional Blue plans with positive medical policy of OVA1, such as Highmark Blue Cross Blue Shield, Blue Cross Blue Shield of Arkansas and Blue Cross Blue Shield of Louisiana. Now with Blue Cross Blue Shield of Michigan, the number of lives covered under positive medical policy of OVA1 is approximately $11 million. In addition we have a methodical plan with select regional market impact study to drive payer coverage, through provider to our already utilizing the technology have adopted it into their practice. [indiscernible] our major growth for the year is obtaining positive medical policy by one national payer by end of 2015. The impact of Blue Cross Blue Shield of Michigan is the beginning of positive trend and medical coverage with payers. Our sales and managed market teams are focusing synergies on the appropriate efforts for these opportunities. I will now turn it back to you, Valerie.
Valerie Palmieri
Thanks, Laura. Let’s now review our health economic data progress our new strategic partnership and our regulatory progress on our second generation test OVA2 in detail. I’m now going to turn it over to Donald Munroe, our Chief Scientific Officer. Donald?
Donald Munroe
Thanks, Valerie starting with health economics, today we will discuss two important developments for Vermillion. First in the presentation of a new cost effectiveness analysis at the Annual Meeting of the American College of Medical Quality, which occurred a few days after our last earnings call. In acceptance is a strategic partnership, we recently announced with Kaiser Permanente of Southern California. Our march 27, we announced positive top line results from the host of presented at the annual meeting at ACMQ. The study co-authored by investigator is that UCI and Stanford University, compared cost effectiveness of three adding ovarian masses using OVA1 versus two important clinical benchmarks. The CA-125 biomarker and the modified ACOG guideline for ovarian cancer risk assessment. Study endpoints included treatment costs, quality adjusted life years or qualities and incremental cost effectiveness ratio called ICER. The health economic model utilized OVA1 performance data from the two perspective OVA1 trials as well as published survival costs and quality parameters. And the best practice patient management decision treatment. In the model OVA1 was life expanding and quality increasing relative to CA-125 and modified ACOG. OVA1 using the model resulted in fewer re-operations and pre-treatments CT scans and modified ACOG or CA-125. And OVA1 improved cost effectiveness or cost effective relative to the $50,000 accepted industry ICER threshold, at about 12,000 per QALY gained compared to CA-125 and $35,000 per QALY gained versus modified ACOG. These new results further demonstrate the value of OVA1 in clinical practice by improving its detection of ovarian cancer through surgery OVA1 may promote better outcomes and reduce the need for re-operations in repeated energy. The second health economics update insurance a new strategic partnership who signed with Kaiser Permanente of Southern California. The partnership brings Vermillion together with one of the nations leading integrated health care providers, to focus on optimizing early recognition and effective management of ovarian cancer care pathways. The first phase of this quality program will benchmark ovarian cancer care across Kaiser Permanente, Southern California network, by retrospectively analyzing electronic medical records, the study will access opportunities to improve patient work up, specialist referral and to optimize utilization of systemwide healthcare resources. The implications for commercial evaluation of OVA2 another Vermillion where ASPiRA offerings are obvious but in addition, the collaboration presents great opportunities for innovation on care paths, treatment decision points, and evidence phase gynecologic health care solutions – excuse me – beyond over unit health. Our current expectation is the first results from the exciting partnership to be published early next year. Finally, last quarter we updated you on the validation and 510(k) submission for OVA2. As we told you then, the 510(k) process can never be taken for granted, however the package has path its first milestone, for so called refused to accept check point, and is now undergoing review. We expect a serious of exchanges with FDA over the summer and we will continue to project OVA2 launch in the third quarter. And as we said, we’re very pleased with the performance achieved in verification and validation of OVA2. In fact two abstracts at OVA2 have been accepted for poster presentations, at the annual meeting of the American Society of Clinical Oncology or ASCO later this year. Due to environmental laws we cannot disclose the results at this time. However the abstracts will become public at 5:00 PM Eastern on May 13 and we will issue a press release at that time. We look forward to provide you more information then and encourage you to stay tuned. I will turn it back to Valerie now.
Valerie Palmieri
Thanks, Donald. In closing we have kicked up this year by accomplishing all Q1 milestones on time or ahead of time. We are well on our way to completing the transformation phase in 2015. As we set our site on the balance of the year, we are starting the planning of our third phase, which is market expansion in growth phase in 2016. By this time we will expect to have completed the following. full national licensure of ASPiRA Labs, a track record for regional value based pricing in payer acceptance, fully exercised regional commercial strategy to OVA2. And lastly initiation of our sample and patient day registry, which we can mine for new disease care pathway patterns to feed and expand upon our current product portfolio. Keep in mind, our goal is to launch OVA2 in the U.S in Q3 with an already existing customer base in addition to making the product available to regional lab and customers outside of the Quest client base. Also due to the new product platform, we can now distribute over to worldwide and anyone of the 10,000 Roche Cobas systems. In addition 2016, will be kicked off with a 25 plus strong salesforce of strong medical science liaison team and a new potential market of over one million patients. The timing is right, women’s health and ovarian cancer have taken on a different perspective in the marketplace. As recently demonstrated by the recent news regarding Angelina Jolie and the creation of the stand up for cancer ovarian Dream Team. Ovarian cancer is now at the forefront of national attention. Our technology has the potential to change the outcomes of ovarian cancer, not only in the U.S. but worldwide and in time make a significant impact on overall gynecologic health. That concludes our presentation and we are ready to take questions.
Operator
Ladies and gentlemen, the question-and-answer session will be conducted electronically. [Operator Instructions] Your first question will come from ROTH Capital Markets, Debjit Chattopadhyay.
Debjit Chattopadhyay
Hey, good afternoon and thank you for taking my questions. Just quick one on the experience from listening over to Quest in terms of your collections and any push backs you may or may not have had given that the OVA1 test has been repriced significantly higher?
Valerie Palmieri
So, Debjit our transition is going to be happening early June, but as far as any push back on the transition as we’re working with regional lab, except there has been no pushback today, but really the – to answer your question in terms of our experience with specific customers, the transition can be early June, so post early June we will be able to answer that question in detail.
Debjit Chattopadhyay
And do you had a proxy about a couple of months with your in-house sales team. So I'm just wondering if you compare the productivity in terms of volume growth of the in-house sales team versus your out-sourced sales teams at last year, how do that compare?
Valerie Palmieri
So, Laura is going to jump in.
Laura Miller
Hi Debjit, it’s Laura. And basically where we are right now is inside sales team has been out on the street as we may say, on the phones about three weeks. And so it is the later hiring process within Q2. And so we will see metrics from both salesforce from the upcoming weeks or months.
Debjit Chattopadhyay
Great. And then the agreements with Kaiser, does that of about have OVA1, on the OVA family of test volume in built it to it in terms of patient management?
Donald Munroe
So Debjit, it’s Donald’s here. No initially, it’s a quality initiative and in dialoging with the principal ovarian gynecologic oncologist as well as OB/GYN. This is really a way to elevate our profile and prove us out as a strategic offset in a way get closer to the medical organization and understand this step. That doesn’t prove a cautionary commercial engagement, but it is a separate causes.
Debjit Chattopadhyay
And one last one, in terms of OVA1’s future once you launch OVA2 in the third quarter, how do you see that playing out. I mean do you automatically transition everybody on to OVA2 or does, is there a role for OVA1 in some types of patients or and I'm just trying to understand what happens to OVA1 during 2016?
Eric Schoen
So the plan is to replace OVA1 with OVA2, but OVA1 does have success in clinical strength that it should be determined, but we – right now it’s a replacement, it is a direct replacement but we’re not going to – we’ll get OVA1 in the shelf completely.
Donald Munroe
And we retaining intellectual property around OVA1 and which book is useful defensively and then in terms of putting it get back into the technology tool chest whereas it may still have a role as Valerie said in other applications.
Valerie Palmieri
Yes.
Debjit Chattopadhyay
As you are talking your base, are your current prescribers aware of the metrics of the OVA2 and are there ordering current ordering [indiscernible] impacted by the anticipated arrival of OVA2? Thank you so much.
Valerie Palmieri
So in terms of the current customer base, the customer base on a Quest size has been very consistent. The customer base on the ASPiRA side, because of the new challenger model that we’re using, we are seeing customers in terms of additional penetration with those customers. But as far as what we have here is we have pretty much we have about six weeks out with these new sales force and then we have about three weeks out with our insides sales force. So I think that early indications are we have positive momentum, Debjit but we’ll have more of the story at our Q2 earnings call.
Debjit Chattopadhyay
Thank you so much.
Valerie Palmieri
You’re welcome. Thank you.
Operator
And next we’ll hear from John Grimley with TJW Capital.
Valerie Palmieri
Hi, John, good afternoon.
John Grimley
Congrats on the progress.
Valerie Palmieri
Thank you.
John Grimley
A couple of questions. I just want to understand the economics of I guess OVA1 and OVA2, but for now just OVA1 you guys have raised pricing and then when you run the test or ASPiRA LABS, can you just compare and contrast what the model should look like in the future, I know there were some upfront cost to get your own lab to build your own lab, but just want to understand how much more levers there is in the model for incremental tests the way you’re – with your own lab and controlling the process?
Valerie Palmieri
So I’ll answer the question in two parts. In terms of additional test in our portfolio, if you look at how the ovarian cancer market has managed today in terms of diagnostics is to ultrasound in CA125. The CA125 has a quite a few off label application. So in terms of portfolio or clinical problems, there are several clinical problems being tend to filed with the public mass registry and we intend to solve with OVA2. So in terms of portfolio, there is a portfolio that is in use today clinically and we are creating the next best product. In terms of leveraging on the price as you know the Quest relationship it was a licensed relationship where we received a license fee for the technology at about $125. So now we no longer, we’re – will be the sales force laboratory, we will no longer license the test. We’re going to perform the test, build the test and capture 100% of the profit. Our list price what is in public domain is 14.95.
John Grimley
Okay. And that list price is up from roughly 600 in public domain about year ago, is that correct?
Valerie Palmieri
That is correct.
John Grimley
Okay. And then pricing on OVA2 have you guys disclosed anything there yet, and if nowhere as we can late, but I just figured out to ask the question?
Valerie Palmieri
Yes, we have not disclosed any pricing process to that.
John Grimley
Okay, great. And then could you just kind of go into a little more detail on this database that you’re going to be building and what the long-term potential value maybe for that based on…
Valerie Palmieri
Sure, Donald Munroe is going to go into detail.
John Grimley
Okay.
Donald Munroe
The one thing – it’s been very fortunate I think the company made a change and focuses are being let’s say a multi-market company for all disease states to focusing on a certain call point at a certain patient journey around gynecologic pelvic masses. One thing we realized along the way, as we started to talk to the doctors who are helping us to with the clinical trials is that we’re looking for [indiscernible] and as consequence we only ended up using honestly, focusing on let’s say a quarter of all the samples that we collected. Now if you why do we have the other three quarters of the samples it’s because those diseases present in a very similar way to ovarian cancer and the doctors are honestly confused about what's what, when they should treat, whether they should treat, whether they suggesting the patient home and wait, waited there, so this is where we really started to talk about the potential just study the problem and use our patient samples patient data and time following this is over a period of time from when they first person, as they go through the sometimes inevitable milestones of the starting surgery as we did decided and diagnosing whether its ovarian cancer or something else. So we really discover that, there is other diseases that have major on that – the materials has been one example, where it may take ten years to get diagnosed. If the approach that was used on OVA1 were to be successful for some of these other disease conditions that we would be able to reuse of risk have been fairly successful for us in terms of how to bring those forward, validate them, publish and get them into practice. So that’s the general just of that and it requires investment because the patient spectrum is broader than what you would find in the current OVA1, testing spectrum where it’s basically plan for surgery. We’re talking about something a little bigger here.
John Grimley
And the only way you can really do that is by being on the front line collecting the samples and then once, bigger that data gets you’ll have the technology to analyze that and come up with even better treatments in the future. Is that the right way to think about it?
Donald Munroe
The hard part is you have to do the work and you have to paid for it, but we have a vision and mission where we’re going to be in this for the long haul and we want to build the franchise. So the flip side of that is that’s an enterprise asset. As you got those samples and data, you start to be in a position that there are few other companies are and we really aim to know more about and be able to do more about these analysis than anyone else.
Valerie Palmieri
In the strategy back on that that accounts plays out majority of our data, by 20,500 patients, majority of that was benign, that we within our conference today have IP resonance data, we’re leveraging that even more with these combination of the whole and higher degree pathway, when looking at endometriosis, PCOS and other gynecologic health issues which impact about 20 million women in the U.S.. So this is one of a kind and plus the issue, as well as you don’t see – it sound like the genomic talk, they had a base trial. There is not a paraffin block database that you can go to regarding to these state and we’re building it. So that’s – that’s the regard.
John Grimley
I guess longer-term we should consider these really a – not an OVA1 or OVA2 as being the franchise or really those being tools that continue to build the franchise for analyzing [indiscernible]
Valerie Palmieri
It’s just a product – one of many, yes.
Donald Munroe
It’s a multi product, multi disease state research asset.
Valerie Palmieri
Within the same customer segment, within the same disease.
John Grimley
Got it and then have you guys – I think you touched on this on the call and my guess will get this out of the ASCO abstracts, but you guys haven’t disclosed other than from – paper like 18 months ago, what the specificity is that we could expect in OVA2?
Donald Munroe
First thing to mentioned is that the – abstract that was published at ASCO, 18 months ago was really kind of I would say, a research proof-of-concept that utilize markers which are sort of manual needle optic not [indiscernible]. And also what the manufacturing stability is not necessarily there. So now we’re taking about IVD grade, routine testing platform which obviously also had to pass FDS’s scrutiny which has a lot of checkpoints to this. So we haven’t disclosed data, the out check will start to lay that out. We’ll have peer-reviewed manuscripts that follow-on with that. But I would actually expect a series of [Indiscernible] just two or more than two. Because we have a very full data set thats start to literally lay out the performance data in detail. So even in the ASCO [Indiscernible] scratch the surface sdue to space limitations.
John Grimley
And OVA2 should help stop what has been the biggest push back. I mean, I guess the OVA1, was wasn’t really being used properly from what I can tell. But it’ll solve the biggest pushback which was not enough specificity for a broad – more broadly used test. Right? So is that right – am I thinking about that the right way?
Donald Munroe
Yes. Definitely it’s something that – I might talk about, I'm not sure that what was that really is, the only or the main pinpoint was that all we are now in position to talk to doctors about how the test could be implemented successfully. We are in a position to help solve problems with non-payments and so on. So I think that’s if there are steps in order to make this as the standard of care that it should be.
John Grimley
And when you use properly the OB/GYN and keep the patients and do the surgery versus some of the patients to the gynecologic oncologists when there is not, first up it is not after them but also the OB/GYN looses the revenue of percentage of patients they didn’t have cancer, is that correct?
Donald Munroe
Clearly the test already does something extremely well, it’s extremely effected in picking up ovarian cancer across all stages it something which allows you to refer the cancer patients however, it has the down side that the specificity in PPV, again that the generals may give up some of the nine patients. So the more we do on the specificity in PPV the better it is for those generals and reach a better balance point in the overall product performance, I think.
John Grimley
Great, I don’t take anymore time. Thank you very much.
Valerie Palmieri
Our pleasure, John.
Operator
Next we’ll hear from Mark Macarro with Canaccord Genuity.
Mark Macarro
Hey guys, thanks for taking the question.
Valerie Palmieri
Our pleasure talking to you Mark.
Mark Macarro
Yes, so my first question is with respect to the contract that you won in Michigan with the Blues plan – do you think it might be likely to add additional Blues contract in addition to the large national player that you commented on by the end of 2015?
Valerie Palmieri
Absolutely, we just – we are focusing on the regional Blues, partly where our salesforce is focused on. So we have a large amount of volume in Great Lakes which that grounds well from providers meeting physicians they basically made a lot of noise where a positive medial policy into, so yes, we are focused on regional Blues and we are focused on one national payer in terms of the milestones that we want to be – by the end of 2015.
Mark Macarro
Great and then I would be curious if your contemplated or maybe identified any potential operational hurdles that you might come across as you kind of complete your transition from Quest over the next couple of months, is there anything that you have identified that you think you might have to overcome or is just anything in particular folks should look out for?
Valerie Palmieri
No, it’s, I would say that’s Quest has been truly our partner to this whole process and really the OVA1 I would say contingency is all about doing it well and doing it right, so we have access to all the payer systems, all of the patients draw stations and they are really ROLLIN Gup there is to leave and helping us through the processes, this is more or less as kind of like here is just relating just pick up for time, but we’re actually elbow going across the goal line together. And I’d probably say the only say risk involved is that there is a lot of customers to transition and some of customers just small customers. So we have put in place as we mentioned that direct salesforce that often inside salesforce just to manage those low touch customers and so those are customers that we potentially see it could be high touch customers overtime. But there are going to some more volumes accounts that, we think overtime there maybe customers that from profitability standpoint may not be important to keep from a profitability standpoint. So that could be some risks involved, but it’s going to be minimal.
Mark Macarro
Okay, great. And then maybe my final question maybe jumping down a little too much, but if you could maybe just talk briefly about your international strategy and in terms of the likely head of going direct or using distributors and then maybe if you could talk about the work involved of securing reimbursement maybe from a country to country level.
Valerie Palmieri
Sure. So we thought it remained in the groundwork quite as we recently got CE marked as well as ISO certified this year. So all that groundwork has been made by our regulatory and quality insurance department and we’re starting to build relationships should I say and it staffs the market that would basically be registered into western medicine. So have a thirst to western medicine. We have quite a few countries calling us proactively, we’re being selective on those that we want to actually quote. and then also partner, in terms of the model, it definitely would be a distributing model, we’re now looking to add anymore infrastructure or do any organic brick and motororder in Ex-U.S. this is definitely be a distribution model. But we’re going to be as I said reconnaissance this year and then in the framework for a forecast for 2016.
Mark Macarro
Great, thank you.
Valerie Palmieri
You’re welcome.
Operator
[Operator Instructions] Next with from a Private Investor, George [indiscernible]
Unidentified Analyst
Hi guys.
Valerie Palmieri
Good afternoon, George.
Unidentified Analyst
Good afternoon. Thanks for taking my call. I think my question was just asked by the prior caller. I was asking about European expansion and like the partners even by name or profile type. So given that it was asked can I just ask you to provide a little bit more color on how you guys think about the type of partnership, the type of distributor you are looking in geographies like your?
Valerie Palmieri
Yes, it really can’t go into that on the call because its a little really but I can tell you that you can learn some those that are ex-U.S. so if yo look at Genomic Health and you look at some of the other diagnostic companies that are ex-U.S. you can see some of their lessons learned so we’re definitely looking at lessons more from others, knowing that international, you’ve got to really understand the environmental culture, the ecos, and we’re going to be very deliberate and planning studying a lot of time planning versus making mistakes and learning as we go through once in a life time planning and little time on execution. So we have it’s almost execution.
Unidentified Analyst
Okay, all right. That’s great. Thanks very much.
Valerie Palmieri
You are welcome.
Operator
And with no further questions in the queue at this time. I would like to turn the conference back over to Valerie Palmieri for any additional concluding remarks.
Valerie Palmieri
Thank you very much, Rebecca. So the conclude, we have a plan and methodical mission to change the course of gynecologic health in the U.S. and worldwide. To recap we have two major phases to complete in 2015. Our rebuild phase and in parallel our transformation phase. The key elements are as follows, execute on our new commercial relationship with Quest. The successful deployment of our new sales strategy to drive sales ramp and penetration with the current and large market of new customers via ASPiRA Labs compelling health economics publications to drive value based pricing as we expand our markets we will be building upon our existing bioanalytics solutions platform in that only change the way of ovarian cancers managed of by pushing early detection upstream and truly understanding the pelvic mass care pathway drivers. We’re setting our sides on our bioanalytics management of a much larger disease paradigm which impacts one out of every five women. We appreciate you attending our call and your continued support. Thank you.
Operator
I would like to remind everyone that this call will be available for replay through May 25, starting later this evening, via the link provided in today’s press release as well as available in the Investors section of the company’s website. Thank you, ladies and gentlemen for joining us today for our presentation. You may now disconnect.