Aspira Women's Health Inc.

Aspira Women's Health Inc.

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Aspira Women's Health Inc. (AWH) Q4 2017 Earnings Call Transcript

Published at 2018-03-14 18:22:09
Executives
Valerie Palmieri - President and Chief Executive Officer Bob Beechey - Chief Financial Officer Marra Francis - Chief Medical Officer
Analysts
Max Masucci - Canaccord Genuity
Operator
Good afternoon, ladies and gentlemen, and welcome to the Fourth Quarter 2017 Vermillion Earnings Conference Call. My name is Melinda, and I will be your coordinator for the call today. With me today are Valerie Palmieri, President and Chief Executive Officer; Dr. Marra Francis, Chief Medical Officer; and Bob Beechey, Chief Financial Officer. This afternoon, they will discuss Vermillion's Q4 2017 performance. 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 a replay information. This presentation contains and answers to today's questions may contain forward-looking statements, including regarding Vermillion's business plans, with respect to ASPiRA IVD, Vermillion's sales strategy, payer coverage, scientific studies, Vermillion's patient portal and Vermillion's sales and research strategy outside the U.S. 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, except as required by law. Forward-looking statements reflect management's current estimates, projections, expectations or beliefs and involve risks and uncertainties that could cause actual results and outcomes to be materially different. Risks and uncertainties that may affect the future results of the company include, but are not limited to, the factors as described in the Vermillion annual report on Form 10-K for 2016 and Form 10-Q for the first quarter of 2017. 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, Melinda. Good afternoon, everyone, and thank you for joining us today. We will start by reviewing our performance against our 2017 priorities, our Q4 and full-year financial results, and we will close with our 2018 priorities as we embark on the most transformative year since OVA1 was launched. Today, 39 women die each day of ovarian cancer, and we are very proud of the impact that OVA1 and Overa is having on patients' lives. Since OVA1 launched, it has made a difference in the lives of over 103,000 patients with 0 safety or efficacy issues. Currently, ovarian cancer is the only sex-specific cancer with greater than a 50% mortality rate and 85% of all ovarian cancers are diagnosed when the cancer is beyond the ovaries or Fallopian tubes. Our goal is to change that. OVA1 is FDA-cleared ACOG-endorsed and covered by Medicare nationwide and Medicaid on a state-by-state basis. It is now covered or has positive medical policy for close to 40% of the U.S. population. Our ultimate goal is to truly change the standard of care for managing both high-risk and low-risk public mass patients as one in five women have a mass in their lifetime. We believe we have the critical foundation block behind us to truly start ramping our organic commercialization investments in the first half with the goal of impactful results in the second half of 2018. The Vermillion team has delivered outstanding performance in 2017. We exited 2017 with a 56% increase year-over-year and positive medical policy with the majority of the new coverage only going live as of January 1 and February 1, 2018, respectively. This sets up 2018 to be the first time since the OVA1 launch that it has had all four pillars of success in place, which include: number one, ACOG guidelines; number two, critical mass of payers; number three, clinical policy endorsement from a leading national benefits assessment company; and last but not least, pricing with profitability based on the value that OVA1 brings to the health care system. Our goals for 2017 were as follows: number one, to substantially increase our positive medical policy covered live and thereby, improving the patient experience; number two, improve operating efficiencies; and number three, establish partnerships to expand OVA1 and Overa's footprint and portfolio. The entire team worked together to achieve these goals united by our mission of playing a key role in transforming how ovarian cancer's risk is managed, treated and with the ultimate goal of making OVA1 the Number 1 ovarian cancer risk-assessment tool worldwide. During 2017, we made significant progress in improving the overall OVA1 customer experience. Our managed markets access team increased insurance coverage for OVA1 by 56% from 80 million to 125 million lives under positive medical policy or contract agreement. We nearly doubled our addressable population from approximately 20% to nearly 40%, and we now have positive medical policy coverage with our first national payer Health Care Services Corporation, better known as HCSC. HCSC covers a total of 14.8 million lives over 5 states, including Illinois, Montana, New Mexico, Oklahoma and Texas. The largest covered lives HCSC state, the State of Illinois, contains just over 50% of the HCSC lives and has moved from positive medical policy to an in-network agreement in close to 60 days with favorable PAMA pricing, a significant achievement. In addition, not only did we increase our covered lives, we also moved a number of our policies from negative policy to positive policy as in the case of Highmark Blue Cross Blue Shield. We believe we are the only ovarian cancer risk assessment test with established and growing coverage as opposed to competitive products, such as ROMA, which have remained experimental and investigational to date with similar payers. Also, key to the customer and patient experience was the launching of our Patient Advocacy Program, better known as our PAP program. This program has had a direct impact on growth. We believe this has had an impact on our year-over-year new customer growth, and this program has supported over 1,500 patients to date. Since Q3 2017, the program has almost doubled in terms of the patients utilized in this service as well. The program proactively assists the provider and patient with understanding both the benefit as well as the cost of OVA1. In addition, our PAP program also assists the patient in locating the appropriate draw station for blood draw. It is truly a white-glove experience for a pelvic mass patient from understanding the risk of ovarian cancer to being a true partner in care throughout this emotional journey. We will now move onto an update of our operating efficiencies in new revenue channels. Our second priority for 2017 was to align our investments to the life cycle of the product, thereby reducing our spend on commercial and R&D and focusing on key publications to support clinical utility and health economics. We published two peer-reviewed papers and have additional papers in process for upcoming publications. While aligning investments, we also grew full year revenue year-over-year for ASPiRA LABS by 23%, and our gross margin for ASPiRA LABS more than doubled. From an overall operating efficiency, we reduced our total reported operating expenses by over $4 million, while improving overall company performance. And last but not least, the most important accomplishment for 2017 was the setting of the stage for OVA1 pricing based on the value it brings to the health care system. With the implementation of PAMA, we received a new market-based Medicare rate for OVA1, which increased the reimbursement rate from approximately $222 per test to approximately $897 per test as of January 1, 2018. Not only did our CMS price improve by 4x, but we also placed OVA1 on the national clinical lab fee schedule for the first time since it was launched. This fee schedule listing sets the bar for price negotiations with payers and channel partners as well, as we were unlisted previously. Also, one note regarding 2017 pricing, we won an appeal on the PAMA price for Overa, which is now priced at $950. Keep in mind, Overa requires the investment in publication to set up for guidelines and payer coverage. So, it will remain an ex U.S. product until that is completed. More information to come on this in future earnings calls. Regarding additional revenue channels on the international front, we formally launched our two-year prospective Overa-Philippines study, and we now have been an Israel-Overa validation study in the works, which Dr. Francis will discuss. Regarding ASPiRA IVD, in Q4, we achieved three major accomplishments: number one, successful completion of the PTK7 IHC optimization study, which was our first companion diagnostic study partnership with a top 10 pharmaceutical company. Number two, we secured multiple products with a biosourcing company, which in addition to being a new revenue source will significantly augment our current IHC test menu. And number three, we are also continuing testing for the global DLL-3 companion diagnostic enrolling trial for small cell lung cancer. Our role was expanded in Q4 to include testing services for a separate safety study for this therapy. I'm now finished with a review of the 2017 performance, and we will now jump into financials and wrap up with 2018 priorities and key catalysts. To discuss our fourth quarter financial review, I'd like to introduce Bob Beechey, our Chief Financial Officer.
Bob Beechey
Thank you, Valerie. Today, we finished our fourth quarter and full year 2017 financial results in a press release, and we will be filing our Form 10-K shortly with the Securities and Exchange Commission. These items are available for download via the Investor's Overview section of our website at www.vermillion.com. Total revenue in the fourth quarter of 2017 was $798,000 compared to $805,000 in the same year ago quarter. This was driven primarily by the loss of a major legacy client bill customer as previously reported in Q3 and also driven by the limited investment we made in our sales to date, which we'll expand upon further in the call. Product revenue for the fourth quarter of 2017 totaled $658,000, compared to $680,000 in the prior year quarter, representing a 3% year-over-year decrease. In addition, revenue on a per test performed basis increased to $345 per test in the fourth quarter of 2017, compared to $301 in the fourth quarter of 2016, representing a 15% increase. Note, this is prior to the effective date of the PAMA price increase discussed by Valerie, which is effective on January 1, 2018. The combination of the low price, volume reduction with the increased prior margin direct sales resulted in gross profit margin expansion from 33% in the fourth quarter of last year to 38% in the fourth quarter of 2017. There were 1,910 OVA1 tests performed during the fourth quarter of 2017, compared to the 2,258 OVA1 tests performed in the prior quarter. We will discuss the breakout of volume between covered and uncovered territories, as well as putting into context our overall volume performance relative to the magnitude of our commercial investment later in the call. ASPiRA IVD service revenue for the fourth quarter of 2017 totaled $140,000 and was an increase of 12%, compared with the prior year quarter. Normally, ASPiRA IVD revenue will vary from quarter-to-quarter based on the size of ongoing customer projects. Cost of ASPiRA IVD service revenue was $303,000 for the fourth quarter of 2017 consistent with the same period in 2016. Total operating expenses or SG&A in the fourth quarter of 2017 increased to $3 million, compared to $2.9 million in the same year ago quarter, representing an increase of 5%. We incurred some one-time severance costs and noncash separation costs of approximately $280,000 in the fourth quarter. Net loss for the fourth quarter of 2017 was $2.96 million as compared to a net loss of $2.84 million in the same year ago quarter. Our net loss per common share was flat year-on-year for the fourth quarter at negative $0.05. Cash and cash equivalents at December 31, 2017, were $5.5 million. The company utilized $2.2 million in cash in the fourth quarter of 2017. I'll now turn it back to Valerie.
Valerie Palmieri
Thanks, Bob. We will now discuss in detail our 2018 priorities, which include leveraging our guidelines, leveraging critical mass of payers, and leveraging our price to now drive organic investment and commercialization, as well as key channel and portfolio expansion partnerships. In terms of investing in this growth phase, it will include four core components: number one, obtain additional regional, national payers and drive adoption, driven by clinical education, clinical utility, as well as strong health economics; number two, drive top line growth via channel partners and alternative revenue channels, including international and ASPiRA IVD; number three, continue to build and leverage the utilization of our one-of-a-kind public mass repository; and number four, portfolio expansion into other pelvic mass conditions. Our Number 1 goal is to obtain additional regional and national payers and drive adoption with our creation and deployment of foundational peer-review papers and programs to support clinical education, clinical utility, as well as health economics. I would like to now hand the call over to Dr. Marra Francis, our Chief Medical Officer, to provide this update.
Marra Francis
Thank you, Valerie. Vermillion continues to expand our clinical and educational awareness through regional and national societal meetings and educational continuing medical education program. In 2017, we attended four ACOG meetings, including their national meeting in May and 9 OMNIA programs. We are looking forward to attending ACOG's national meeting again this April, as well as many of the regional ACOG meetings throughout our current and newly expanded covered territories. As we continue to educate providers individually on the benefits to their patients using OVA1, we are happy to announce that Omnia Education recently launched a program on February 28 titled Best Practices for the Workup of the Adnexal Mass, and it includes OVA1 use in patient care. This program offers pre-CME credits to health care providers through web-based platforms. Omnia Education is the leading provider of education for women's health professionals. Their activities are recognized nationwide for providing credible, relevant and practical information on issues impacting the female patient. This Omnia program can be accessed via a link on our website. We are also excited to announce that our first prospective outcome study on our second-generation test Overa in conjunction with the University of the Philippines College of Medicine, Departments of Obstetrics and Gynecology and Pathology is successfully underway. The study began enrolling participants in Q4 of last year and is anticipated to be completed in Q1 of 2020. To date, the study has enrolled 87 women with both cancerous and benign adnexal masses. This study will look at the benefit of adding Overa in the care pathway of the woman with an adnexal mass to appropriately triage them to the highest level of care needed, while safely retaining women for surgical intervention with OB/GYN in cases where a specialist is not needed. We have identified a site for our validation study on Overa in Israel. Completing a validation study is necessary to set the stage for successful commercialization there. Also, we are looking to begin a study on using OVA1 and Overa instead of CA125 for the routine monitoring of high-risk ovarian cancer patients due to a BRCA mutation. Approximately one out of every 40 women in Israel are BRCA carriers versus one out of 400 here in the United States. Understanding how Multivariate Index Assay performs in this cohort of women at the highest risk of developing ovarian cancer is crucial to expanding the clinical utility of our test. We have also begun to identify study sites here in the United States for our OVA1 retrospective clinical utility study, which will compare outcomes for adnexal mass patients both low and high risk between OVA1 and CA125. The study will look to identify the ability of OVA1 to appropriately identify the risk of cancer in women ultimately diagnosed with ovarian cancer when CA125 failed to alert the provider that a significant risk existed. It will also follow the care of low-risk OVA1 patients in real-world clinical settings, highlighting the benefits of OVA1 high-negative predictive value. Lastly, we will continue to educate women on the signs and symptoms that may be associated with pelvic mass disease. We are in the process of changing our quiz on no pelvic mass to the Goff Symptom Index quiz, as well as creating tools for providers to use in their office incorporating symptoms into their adnexal mass workup. Soon we hope to create a patient portal for women to voluntarily report both symptoms and adnexal mass clinical outcomes with and without the use of OVA1 to increase our patient database.
Valerie Palmieri
Thank you, Dr. Francis. The publications that Dr. Francis reviewed are directly related to reimbursement expansion. Now that we have 40% of the lives covered in the U.S., we are focused on the other 60%, which include the other nationals and regional players. Keep in mind what drives the other nationals is competitive pressure and today, we have 55% of the Blue Cross Blue Shield lives under policy and this directly relates to the 60% to 80% of the covered lives in the territories where we field representation. Causing a tipping point in these markets is key and now with the new coverage going live in January and February, we believe we are close. More to come on the next earnings call. In addition, a key part of optimizing our market and revenue share is price improvement. The majority of our covered lives are under positive medical policy versus contract agreement. This now allows us to price these contracts as a new payment price focusing on the 80-20 in priority order. Regarding those that we already have a contract with, we are moving them from the current old CMS price to the new PAMA price range based on the national clinical lab fee schedule. We are in various stages of negotiations with several contracted payers for fee increases. One 2018 goal, which is over the line, is the confirmation of the new CMS price with actual claims. We have confirmed that Medicare has paid approved 2018 claims as a new PAMA price of $897. In addition, keep in mind, this price is locked in for 3 years. Now moving on to our 2018 goals for our 3 revenue channels: domestic, international and ASPiRA IVD. On the domestic front, our key 2018 goal is to now maximize our value; leveraging guidelines, payers and price; and to optimize patient experience. This optimization now includes a dedicated internal Quest resource to manage our OVA1 specimen flow capacity and communications, which support our physicians and patients directly. Coupled with our new Quest resource, we now believe it's time to invest in our commercial infrastructure driving organic growth. We started some additional investments late in 2017 when we announced our new payer and price traction. But keep in mind, in 2017, we maintained a very small team of only five field reps and two inside sales reps. I'm happy to report today that we have a total of nine field reps in key markets and two inside sales reps. Although we did have a small team or smaller team, we did continue to grow year-over-year volume in covered versus uncovered territories. Our Q4 year-over-year volume per day in covered territories increased 21%, prior to receiving these payer contracts, while our uncovered territory volumes decreased by 36%. As stated previously, the majority of this was driven by the loss of a large client bill customer in July as noted in our last earnings call. We have also demonstrated consistently that covered territories grow while uncovered territories contract over time. Our strategy in 2018 is to limit uncovered territory space with targeted sales rep placement based on opportunity. We expect to increase the coverage of our total volume by 20% in 2018 to limit overall attrition. Regarding the new rep and payer coverage, we do have some early indicators, which are showing meaningful results. The first example of new field coverage is in New York Metro. The territory had a Q4 average of two specimens a day. After a few months in the field, in Q1 2018, we are seeing up to three specimens a day or another 63 per quarter. An example of increased payer coverage is in our Illinois territory where we have nine out of 10 lives covered in the state. In only the first 45 days of policy changes, our volume per day grew from two specimens per day to close to four per day Q1 2018 to date. Due to the new payer coverage, we are seeing a market increase in volume per customer as well. We are also encouraged with our early results in adoption and repeat business into hospital systems and larger networks in this territory, which is facilitating further accelerated growth. I'm now moving beyond increasing our sales force, we're also focusing on domestic partnerships with health care systems and channel partners. Now that we have improved economics and approaching critical mass of covered lives, we are in active discussions with channel partners and health care systems. Our technology has documented strength over alternative technologies, such as CA125 and ROMA and agreements with the right partners in time are expected to help increase market share. I'm now moving on to our 2018 goals for other revenue channels, including international and ASPiRA IVD. For international, we are going to continue to move forward with our studies in the Philippines and Israel. The Philippines study goal is to enroll 380 patients, 190 benign and 190 malignant patients. We believe this perspective outcome study will be a significant contributor towards critical mass payer coverage in the U.S. when it's completed in late 2019 and published in 2020. In addition, our Philippines distributor MacroHealth is poised to distribute Overa to their national client base over that time. The end goal is adoption of Overa into the Filipino health care system protocol, but the major value here is the perspective Overa outcome study, which can be used worldwide. I'm now moving on to Israel. The initial Israeli study will be the Overa validation study. The total enrollment is 240 patients over an estimated 12 months. The end goal for this study is to demonstrate Overa's performance on the local population. This approach is similar to the Genomic Health integration via the same distributor Progenitics and adopting the Oncotype DX technology in Israel. The Israeli entrance in Overa is due to its high-negative predictive value in the hope it can help reduce the number of public mass surgeries with GYN oncologist involvement. This is a major issue due to the high BRCA incident rate in Israel. Although we expect the top line impact of our international partnerships to be minimal in the short term, these studies could be transformative for the business from prospective outcome basis, negative predictive value performance and BRCA focus. It is also important to note that about 90% of the ovarian cancers worldwide are outside of the U.S. and Overa is just starting to be utilized in that global market. For 2018, ASPiRA IVD will largely complete the initial enrolling phases of the DLL-3 study that have begun in early 2017 and transitioned into the support of safety and compassionate use studies for this therapy. Additionally, we look to expand our direct relationships with major pharma, but the goal is retaining more studies and projects directly sponsored by them. Our third initiative for 2018 is expanding and mining our one-of-a-kind public mass repository, which is intended to be the core of our Big Data engine in public mass portfolio. The goal of this repository is to support the development of new products and predictive analytics in ovarian cancer, as well as a differential diagnosis of benign public mass conditions. To date, we are seeing approximately 20% return rate on patient consents, which is much higher than we anticipated. We also have received close to 300 patient records to date. We intend to publish our data in time. Keep in mind, patient consent will allow us to receive additional clinical and diagnostics data, as well as pathology reports, which are gold standards in diagnostics. This will allow us to see how doctors truly manage low-risk and high-risk patients with our technology. As we all know, ovarian cancer remains one of the most challenging diagnoses to make early in the disease process. We believe that harnessing this data will be key to truly understanding the origin, contributing factors, prevention and successful treatment of the disease through development of future bioinformatics solutions. Our fourth and final goal is the incorporation of our data and specimen with complementing technology partners. We are in active discussions with technology partners to increase the applications for OVA1 and Overa, as well as increase our overall test offering and portfolio. Due to ovarian cancer being a rare disease, many of these potential partners are not focused on ovarian cancer. So, Vermillion is an attractive partner given our specimen and data bank. Our goal is to manage high-risk and low-risk patients over their entire care pathway from diagnosis to treatment and to cure. In closing, thank you for joining us today as we discussed the performance against our 2017 priorities and outlined our 2018 priorities. Vermillion is uniquely positioned to create value and the early accurate risk assessment of ovarian cancer. Our focus growth in specific regions and transformative pair success has set the stage for scaling our revenues with direct and indirect channels in 2018 and 2019. We look forward to keeping you apprised of our progress during 2018. Our end goal is to truly enhance shareholder value by saving lives and saving money for the overall health care system. We are now happy to answer your questions.
Operator
Thank you. [Operator Instructions] And we will go to Mark Massaro, Canaccord Genuity.
Max Masucci
Hi. This is Max Masucci on for Mark.
Valerie Palmieri
Hi Max, good afternoon.
Max Masucci
Hi, how is it going?
Valerie Palmieri
Good.
Max Masucci
Can you talk about your overall visibility into the business in 2018? And the decision to not provide in 2018 guidance and you're now recurring orders at the higher $897 PAMA rate for OVA1, will that imply that your revenue per test could trend upward into the $400 to $500 range in 2018?
Valerie Palmieri
So, let me answer that in two parts. One in terms of guidance, we just received these contracts in January and February, where tests, as I said, the first half of this year really putting our recruiting efforts behind our sales force. So, we're not ready for guidance just yet. We need a couple of quarters behind us with a fully trained sales force and that we can see the patterns in the business. So that's the answer to the question number one. Question number two, we do think that our price will definitely be impacted by this change. We're seeing that as we mentioned in the Blue Cross Blue Shield agreement, as well as Medicare is paying the rate, which they set out to pay. So, you will see price improvement over the year. In terms of giving guidance on the price, it's just too early, Max.
Max Masucci
No problem. And next we've seen a number of companies call out unexpected weather and flu impact for Q1 of 2018. Do you expect this to impact your Q1 volumes? And would you be able to quantify what that step down might look like from Q4 to Q1?
Valerie Palmieri
Yes. There was a couple of days in January that we did have some weather issues and most recently here in the Northeast, as we know we've gotten ahead with these Northeasters, but I don't think it's substantial, Max. I mean, I can't comment on it in terms of guidance, but there definitely were some delays. But you think over time, the delays should catch-up over time as patients basically being rescheduled. But there definitely is some impact, but as far as giving guidance, I don't have that to give you right now.
Max Masucci
Okay. Great. And then one more if I can? So, we have the ACOG annual meeting coming up at the end of April, should we expect any publications or news flow out of the meeting that might prompt the addition of another commercial payer in 2018? And could you also clarify how many of your positive coverage decisions are contracted?
Valerie Palmieri
Okay. So, in terms of ACOG, I do not think we will have a publication before ACOG. In terms of new payer news, that's something that we are constantly working on and in dialogue with. And then in terms of your last question, we anticipate, as I said, we anticipate our price to continue to improve, and we anticipate the first half of this year, as I said, being our investment first half and our second half is where we'll see more of our impact in terms of our results.
Max Masucci
Okay. And then just one more. Could you just clarify how many of the positive coverage decisions are in contract?
Valerie Palmieri
In terms of the - so most of the covered lives that we have are positive medical policy. We are right now converting the majority of positive medical policy versus contract. So, the upside is, is that they are not set on a certain price, and we're seeing – as I said, we're in negotiations with several.
Max Masucci
Awesome. That’s it from me. Thankyou.
Valerie Palmieri
Thank you, Max.
Operator
[Operator Instructions] And that does conclude our question-and-answer session. I would now like to turn the call back over to the – I do apologize, we do have a follow-up from Max.
Max Masucci
HI. Maybe I can sneak a couple of more in here. So, in terms of 2018, should we be thinking of 2018 as, again, an OVA1 story here, when do you expect Overa to, I guess, become a meaningful contributor and – yes?
Valerie Palmieri
So, yes. So, 2018 in the U.S. it will be an OVA1 story because we just got into guidelines, we just got payer coverage. Overa is we are investing in publication ex-U.S., but Overa could quickly become a – in terms of a revenue story ex-U.S. and that will be latter half of 2018, early 2019, and more to come on that. So, Overa is more of an ex-U.S. play until we get our publications lined up and payer coverage, OVA1 is in U.S. play. And our goal is to make OVA1 basically be the standard of care for ovarian cancer risk management.
Max Masucci
That sounds good. Thank you.
Valerie Palmieri
You’re welcome.
Bob Beechey
Okay. And this is Bob Beechey. We have one question online from Brad Wickson [ph], I apologize if that's a mispronunciation, from SPC Global. The question was, can we have an explanation on why the legacy customer decided to drop? And if that should concern us about other providers? We believe that the reason for the discontinuation of that relationship was really price. And from a go-forward look perspective, I think quite the opposite. Our economics are changing dramatically with our new price going forward and that contributed – the loss of that customer while it contributed to volume declined, actually, the positive mix we had a 4-percentage point increase in our gross margin in Q4. And looking forward, we're going to have the flexibility to work with other channel partners in a win-win. There is enough economics to go around in terms of future channel opportunity. So, on the contrary to viewing, it is a positive going forward. I think it's an indication that our legacy pricing wasn't adequate to share enough profit across the value chain, inclusive of distributor. So, stay tuned going forward. As we have noted, we have active discussions going on.
Valerie Palmieri
Yes. And if I could just piggyback on that. So, this legacy customer for those that are just joining into this call for the very first time, this is part of our Quest legacy relationship and Quest had a quite a few relationships with client bill customers, which they take a piece of your profit. So, this is a customer that had high volume with low margin. As Bob pointed out, now that our economics have changed, we would not be honoring a relationship like that. It will be a much different relationship with more margin on our side. So, it's a positive in the long run, and it's not an indication of the quality of the test nor the performance of it clinically. It was simply an economic decision. I hope that answers the question.
Operator
And this does conclude our question-and-answer session. I would now like to turn the call back over to Valerie Palmieri for any closing remarks.
Valerie Palmieri
Thank you, Melinda. In closing, our 2017 accomplishments have set the stage for a strong 2018 and 2019. During the past 24 months, the core foundry work, including guidelines, 40% of the U.S. population under coverage and a 4x increase in CMS pricing have set the stage to drive growth and profitability. I'm very, very proud of the team and what we have accomplished in the last two years. And as a benchmark to other disruptive technologies, such as Genomic Health, Oncotype DX and various sites of pharma, these milestones have been accomplished in record time and with minimal burn. Lastly, we have laid the foundation for our one-of-a-kind public mass repository, which is intended to be the core of our Big Data engine and pelvic mass portfolio extension with complementing technologies. Our engine mind is a development of a portfolio to push early detection upstream and build proprietary science to manage all types of pelvic mass conditions, which impact 1 out of every 5 women in the U.S. over their lifetime. Our end goal is to serve a large global market with a platform coupled with strong science, 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.
Operator
And that does conclude today's conference call. We thank you all for joining us.