Aspira Women's Health Inc.

Aspira Women's Health Inc.

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Aspira Women's Health Inc. (AWH) Q3 2017 Earnings Call Transcript

Published at 2017-11-12 16:36:08
Executives
Valerie Palmieri - President and Chief Executive Officer Dr. Marra Francis - Chief Medical Officer Eric Schoen - Senior Vice President of Finance and Chief Accounting Officer
Analysts
Jacques Villefranc - LifeSci Capital John Grimley - TJW Capital
Operator
Good afternoon, ladies and gentlemen, and welcome to the Third Quarter 2017 Vermillion Earnings Conference Call. My name is Catherine, 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 Eric Schoen, Senior Vice President of Finance and Chief Accounting Officer. This afternoon, they will discuss Vermillion's Q3 2017 performance. Before we get started, I'd 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 today's questions may contain forward-looking statements, including regarding Vermillion's business plans, plans and expectations with respect to ASPiRA, I beg your pardon, IVD, Vermillion's pelvic mass data repository, Vermillion's cloud web service platform and international commercialization anticipated pricing and test volumes, Vermilion's ability to expand pair coverage for its test, the potential impact of scientific publications and study outcomes, Vermillion's ability to expand its sales force, anticipated cash utilization and anticipated revenue and the timing of recognition thereof. You are cautioned not to place undue reliance on the 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 or 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 quarterly report on Form 10-Q for the first quarter of 2017. Following the Vermillion's team remarks, we will open the call for your questions. Now, I would like to turn the call over to Ms. Palmieri. Please go ahead.
Valerie Palmieri
Thank you, Catherine. Good afternoon, everyone, and thanks for joining us today. This afternoon, I will provide you with highlights of the quarter as well as the full review all of some recent announcements, which are key milestones in the implementation of our overall strategy. Over the past 24 months, since ASPiRA LABS became the exclusive provider of OVA1, we have done the hard work to establish a strong foundation for growth. A foundation based on guidelines inclusion, payer acceptance and value-based pricing for OVA1. When we unwind our exclusive contract request, we knew we had to go backward in order to go forward stronger. We had to create new studies and publications to support inclusion in guideline. We had to establish from scratch our own medical coverage policy with payers and we had to reset the value equation for OVA1 from very, very low level to much higher levels supported by its strong health economics. The first major catalyst occurred in Q4 2016, when OVA1 was established in the ACOG guidelines for the management of adnexal masses in woman. And in Q3, in Q4 of this year, we have two additional catalysts as we now have made major progress on pricing and payer acceptance. Regarding the price, our value for OVA1, we're happy to report that we now have preliminary 2018 finance for Medicare and Medicaid services pricing for OVA1 and Overa based on the Protecting Access to Medicare Act of 2014, better known as PAMA calculated rate. CMS has published a preliminary price for OVA1 at $897. This is a fourfold improvement from our historic pricing from our local Medicare carrier, which did not follow a formal market-based rate process. We are in full support of the new PAMA method, which used a median average of third-party payments from January to June of 2016. This payment method allows OVA1 to finally be properly valued by CMS based on open market pricing. In addition to reaching our internal price target, we have also invested in payer studies and a new pair dossier that has resulted in OVA1 being recognized as a medical necessity by a National Medical Benefits company. Based on the national benefit company's positive policy decision, last week we announced a 27% increase in positive policy covered lives. For a total increase of over 26 million covered lives, including the plans that comprise a national payer known as Healthcare Services Corporation for a total of 14.8 million lives. This plan includes five states, Illinois, Montana, New Mexico, Oklahoma and Texas. In addition to HCSC, this medical benefits policy update today has also included Horizon Blue Cross Blue Shield High mark Blue Cross Blue Shield, Well care and five smaller plans. These two catalysts, the new pricing threshold set by PAMA and a significant covered lives coverage are staminal event for our growth base, coupling this with our November 2016 ACOG guideline inclusions. We will now position OVA1 for growth in 2018 and '19 and we will finally allow us to price OVA1 at the higher value it provides to improving patient outcome. In addition to these two major accomplishments, we will now have OVA1 and Overa placed on the CMS clinical lab fee schedule through the PAMA process for the very first time. And we are also announcing a significant shift from existing positive clinical policy coverage contracts moving to in-network agreements as indicated by the recent Blue Cross Blue Shield Louisiana and Michigan news. A fundamental component of our strategy, since leading the exclusive collaboration with Quest, which reduced our commercial footprint and associated burn until we had the foundation of guidelines, price and payer contracting in place. We have paid the price of considerably reduced OVA1 volume and going from national commercial coverage to regional hotspot coverage model in the last couple of years. In spite of this limited commercial investment, each quarter we have grown year-over-year revenue overall in-volume in covered territories. In Q3, our revenue grew 13% year-over-year, overall, and our volume per day in-covered territories grew by 2%. This is in spite of a guided decrease of 5% to 10% as well as a hurricane impact in Texas and Florida. The metrics also directly impacted year-over-year growth product margin, which improved by 19%. All of these improvements are a direct relationships to the strategic investments that we have made over the past few years to achieve guidelines, pricing and payer adoption. This afternoon, we will discuss the details of our third quarter performance, the large market opportunity that remains to OVA1 and Overa and we will outline the additional investments we are making in the business to maximize our ability to capture the opportunity. We are very proud of the impact that OVA1, Overa are having on patient's lives. Keep in mind, since OVA1 launched in 2010. OVA1 has touched over a 100,000 women with zero safety or efficacy issues. As we build out our patient outcomes program, we are able to better understand the number of cancers detected even at an early stage as well as the percentage of newly diagnosed women, for which OVA1 has made a difference, and ensuring that the initial treatment was performed in consultation or by a gynecologic oncologist. This improvement in proactively managing woman at risk can be a difference of life or death. Keep in mind over 60% of Ovarian cancers are diagnosed late stage, and close to 66% of primary ovarian cancers do not have their initial surgery performed by a gynecologic oncologist. It is widely accepted that initial care with a specialist directly result in a 30% to 40% decrease in mortality. Also, due to the majority of adnexal masses being benign, understanding the low-risk management care pathway is critical for a patient's peace of mind, while improving patient outcome and reducing cost. Today, OVA1 is FDA cleared, covered by Medicare and included in a major society guideline. It is covered in our positive medical policy for close to 38% of the U.S. population, almost four out of 10 lives nationwide. Our goal is to truly change the standard of care for managing the one million plus women with the pelvic mass. And we believe we have a critical foundation blocks to start 2018 strong, and we will discuss our growth phase plan shortly. To discuss our third quarter financial review, I'd like to introduce Eric Schoen, our Senior Vice President of Finance and Chief Accounting Officer.
Eric Schoen
Thanks, Valerie. Today, we furnished our third quarter 2017 financial results in a press release and filed 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. Product revenue in the third quarter of 2017 totaled $657,000 compared to $581,000 in the prior year quarter, representing a 13% year-over-year increase. ASPiRA IVD service revenue in the third quarter of 2017 totaled $42,000 and was consistent with the prior year quarter. Normally, ASPiRA IVD revenue will vary from quarter-to-quarter based upon the size of ongoing customer projects. Total revenue in the third quarter of 2017 was $699,000 compared to $623,000 in the same year-ago quarter, representing an increase of 12%. There were 1,954 OVA1 tests performed during third quarter of 2017 compared to the 2,257 OVA1 tests performed in the prior year quarter or a 13% decrease. We will discuss the breakout of volume between covered and non-covered territories as well as additional context on third quarter volume in the sales review portion of this call. We do expect volume in the fourth quarter of 2017 to increase, compared to the third quarter of 2017, on a per day basis. In addition, revenue on a per test performed basis increased to $336 per test in the third quarter of 2017, compared to $257 in the third quarter of 2016, representing a 31% increase. Cost of product revenue for the third quarter of 2017 totaled $495,000, representing a 7% increase from the prior year quarter due to some equipment maintenance cost and higher consulting cost in the third quarter compared to the prior year. Our gross product margin improved to 25% in the third quarter of 2017, compared to 21% in the prior year quarter. Cost of ASPiRA IVD service revenue was $284,000 for the third quarter of 2017 compared to 356,000 for the same period in 2016. The decrease of 20% was due primarily to consulting cost related to the initial operations of the IV lab in the third quarter 2016, which were not repeated in 2017. Total operating expenses in the third quarter of 2017 decreased to $2.4 million, compared to the $3.3 million in the same year ago quarter, representing a decrease of 26%. The decrease was due to reductions in consulting and marketing services and lower health economic study cost in the third quarter of 2017 compared to 2016. Net loss for the third quarter of 2017 was $2.5 million as compared to a net loss of $3.5 million in the same year-ago quarter. Cash and cash equivalents at September 30, 2017 was $7.8 million, including net proceeds of $3.6 million from a common stock warrant re-pricing in August 2017. We repriced $3.8 million common stock warrants with an original stock price of $2 per share to a price of $1 per share in exchange for immediate exercise. So $1 price was the market price at the time of agreement execution, less the customary discount. The company also utilized $1.9 million in cash in the third quarter of 2017. We expect cash utilization to remain under $2 million in the fourth quarter of 2017. Now I'll turn it back to Valerie.
Valerie Palmieri
Thanks, Eric. We will now discuss in detail our plans to leverage our price, payers and guidelines and our commercialization plans so we can maximize OVA1 and Overa's adoption in overall company growth. In terms of investing in its growth phase, it will include four core components. Number one, the successful deployment of our domestic and international commercialization strategy based on focused clinical education, clinical utility as well as health economics to drive sales and payer coverage. Number two, commercial investment in expanding our sales force in higher payer penetration areas, and I will be sharing some recent examples of success with our two new expansion areas. Number three, top line growth via additional revenue channels, including domestic and international partnership as well as ASPiRA IVD. And number four, with continued growth. We'll be laying the foundation of our one-of-a-kind pelvic mass repository, which is intended to be the core of our Big Data engine and pelvic mass portfolio. We will now review the first objective, which is a publication of foundational payer review papers to support payer and guideline adoption. I would like to now hand the call over to Dr. Marra Francis, our Chief Medical Officer to provide this update. Dr. Marra Francis: Thank you, Valerie. On the clinical side, Vermillion continues to expand our customer base through regional and national societal meetings and educational CME program. In 2017 to date, we have attended four ACOG meetings, including International meeting in May and nine OMNIA program. As we continue to educate providers individually on the benefits to their patients using OVA1. We will be expanding that education in 2018 with a CME program on all aspects of OVA1 in clinical practice, from the care pathway to the patient advocacy program. We are happy to report that there will be no cost to health care providers for taking this CME course. We are also excited to finally discuss in detail the accepted manuscript and soon-to-be published novel paper in the journal, American Health and Drug Benefits, titled, Economic Impact of Increased Utilization of Multi-Variant Assay Testing to guide the Treatment of Ovarian Cancer, Implication for Payers. The paper details, the base case of a budget model impact that dynamically tracks the effect of OVA1 adoption in lieu of the current standard of care, CA125, for the appropriate patient population. The total cost of care of the patient's journey expressed as a per member per month or PM/PM value has been calculated for both commercial and Medicare covered lives. This study includes the development of a budget impact model, utilizing claims data from a total of almost 93,000 health plan members, comprising approximately 48,000 commercially insured members and almost 45,000 Medicare beneficiaries. Sensitivity analysis revealed potential savings of up to $0.17 per member per month for commercially insured patients and up to $0.05 per member per month for Medicare beneficiaries. These results of the budget-impact model support the use of OVA1 instead of CA125 by indicating that cost savings can be achieved while reaping the clinical benefits of improved diagnostic accuracy, early disease detection and reductions in multiple and possibly unnecessary referrals to gynecologic oncologist. Lastly, we are excited to announce that we have begun a perspective study on our second-generation test Overa in conjunction with the University of the Philippines, College of Medicine, Departments of Obstetrics & Gynecology and Pathology. The study began enrolling participants this month and is anticipated to be completed in Q1 of 2020. This study will look at the benefit of adding Overa in the care pathway of the woman with an adnexal mass to appropriately treat women to the highest level of care needed, while safely retaining women for surgical intervention with the Ob-Gyne, in cases where specialists in not needed. Additionally, we will continue to educate women on the signs and symptoms that may be associated with pelvic mass disease by creating a patient portal for women to rollout the Goff Symptom Index quiz, so that woman may have educated discussions with their health care providers. I will now turn this back to Valerie.
Valerie Palmieri
Thank you, Marra. I will now give you an update on our three revenue channels, domestic, international and ASPiRA IVD. On the domestic front, we believe we can capture a significant market share and profitability in payer-critical mass areas. We expect to expand our sales force further as we are seeing nice dividends in our newly covered territories. These recent additions in key markets further reduced our Quest legacy territories in subsequent attrition in the business. For example, in our California territory, where we recently added a rep, we experienced 17% year-over-year volume growth per quarter, while volumes in our Maryland territory grew 150% year-over-year per quarter. In addition, we recently stacked our New York area and our volumes in that territory grew 27% quarter-over-quarter. Converting cap Quest legacy territories to core covered territories is a priority. We are confident that new customers will continue to adopt OVA1 at a strong pace where we have sales force present. If you compare the growth in territories with field representatives versus territories with no field coverage, covered territories grew 2% year-over-year per day, while noncovered territories supported only by inside sales representatives decreased 35% year-over-year per day, with the majority of the lost due to legacy client bill customer and hurricane impact. In summary, our coverage territories grew 7% to 12% year-over-year and with the previously announced net client bill customer loss and unpredictable hurricane impacts, we actually grew by a net of 2% per day. Beyond increasing our sales force, we are also focusing on domestic partnership with healthcare systems. Now that we now have our preliminary PAMA price and we are reaching critical mass of positive payer coverage, we believe distribution partners in health care systems can play a larger role in building our volumes. Our technology has documented trends over alternative technology such as the CA125 and ROMA. And agreements with the right partners are expected to help increase market share. I also want to share some of our latest results on our patient advocacy and care program, which has indirect impact on growth. We have supported over 500 patients through this program and have demonstrated over 99% success rate and patient authorization of OVA1 being performed after a detailed review of the patient options. The program proactively assists the provider and patient with understanding both the cost and benefit of OVA1. Addressing upfront insurance coverage directly with the patient removes the provider from having to be an insurance expert. We have received strong support from our physicians for this programs. And we have noted that physicians who are enrolled in the program actually increased the number of test ordered once patient billing concerns are removed. In addition to increasing the understanding of cost and value of our technology, are better known as PAD program also assist the patients in locating the appropriate job stations for blood draw, it's truly a white-glove practice for all of our customers. In addition, within the last year, we have launched OVA1 plus and our second-generation test Overa with our targeted launch program. Coupling publications, volume and reimbursement strategy together, it's critical to the rollout. As you know, we recently received our CPT code, POA 0003U for Overa and we are happy to report that we now have a preliminary price assigned to this code for the plan January 2018 clinical lab fee schedule. Overa was originally assigned with the GAAP filled pricing method, which will push pricing to 2020. We were able to successfully crosswalk Overa to a similarly structured test on the current lab fee schedule. Although, this is not the final pricing for Overa, this crosswalk allows Overa to currently be build and achieve a higher pay rate versus the GAAP fill process. In summary, Overa receives a favorable rate years before we would have had under the GAAP fill process. More information will be coming on this in the future earnings call. Let's now turn to Insurance coverage. The number of lives under positive medical policy increased 27% to 123 million in the third quarter, which is about 38% of the lives in the U.S. This is a 68% increase in covered lives since we relaunched OVA1. I also want to emphasize that the new positive coverage we just received is the transition from negative policy to positive policy for many of these plans. Currently, we are the only ACOG Level B technology, which is actually increasing market share in terms of receiving positive clinical policy endorsement in covered lives. Also during 2017, we are seeing positive policy change to in-network agreements for 22 plans, which is in addition to payer coverage changing from negative policy to positive policy as outlined above. Our market access team has performed well and is now focused on turning positive coverage decision into contracts while we continue to expand new coverage for both commercial and government plans. We expect to make continued steady progress on expanding coverage of OVA1 in the remainder of 2017 and 2018. I'm now moving on to our other revenue channels, international and ASPiRA IVD. We continue to have discussions regarding two international business models, centralized and decentralized, both designed to meet the unique needs of each country outside of the U.S. We expect to implement our web services platform in key countries starting with the Philippine study enrolling now. We have a few additional countries, which we are lining up to offer Overa to their women as well. Although, we expect the current impact of international contracts to be minimum, as we worked through markets, regulatory and payer issues in the local jurisdictions, we expect a sales outside of the U.S. to have overall positive impact on our volume and revenue in 2018 and beyond. It is also important to know that 90% of ovarian cancers worldwide are outside of the U.S. and we have just started to enter this market potential. Now, moving on to ASPiRA IVD. ASPiRA IVD recently celebrated its one year anniversary and is now a fully functioning clinical trial testing site with the following accomplishments. Successfully launched the PTK7 IXC optimization study, which is the first companion diagnostic study partnership with the top 10 pharmaceutical company, which we announced on our last earnings call. We also recently secured our second companion diagnostic study partnership with a top 10 pharmaceutical company, which will involve the further development of the immunotherapy biomarker, PD-L1 in nonsmall cell lung cancer patient. We are also continuing testing for the global DLL-3 companion diagnostic enrolling trial, sponsored by a major pharmaceutical company as well as an in-vitro diagnostic company for patients with small cell lung cancer. Our role is expanded in Q3 to include testing services for collection sites located as well in Australia and the EU. As reported on the last earnings call, we continue to see studies focused on oncology therapies such as DLL-3 to have slower patient enrollment than previously budgeted. This still represents a potential risk to revenue realization. Our last objective is building a one-of-a-kind pelvic mass repository, which is intended to be the core of our Big Data engine and pelvic 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 pelvic condition. To date, we are seeing approximately a 20% return rate on patient consent, which is much higher than we anticipated. Keep in mind, patient consent will allow us to receive additional clinical and diagnostic data as well as pathology reports, which are the gold standard in diagnostics. This will truly allow us to see how doctors manage low-risk and high-risk patients with our technology. Once we have enough data we intend to publish as well. 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 this disease through the development of future bioinformatics solutions. The end goal of our program will be the incorporation of our data and specimens as well as our collaboration of top academic institutions to share clinical, epidemiological, genetic, proteomic data on various types of benign and malignant pelvic mass conditions. In closing, we believe that the third quarter of 2017 was another milestone quarter in terms of revenue, growth in specific regions and monumental pair success to set the stage for the rest of 2017 and through 2018 and 2019. We plan to define our company's success using the following four metrics; number one is revenue growth. Revenue growth will be how we measure the effectiveness of our investment in sales as well as how we leverage partners in our decentralized platform. Number two is reimbursement expansion, including percentage paid, average unit price and expansion of covered lives. Number three is the continued development of scientific and clinical evidence, which we serve as a foundation for test adoption, including the management of low and high-risk patients, additional guideline inclusion and pair coverage policies. And number four is our profitability, as we grow revenue and improve operating efficiency with the eventual goal of profitability and continued investment back into the business. We look forward to keeping you apprise of our progress during 2017. Our end in mind is to enhance stockholder value by saving lives and saving money for the overall health care system. We are now happy to answer your questions.
Operator
[Operator Instructions] We'll go to Jacques Villefranc with LifeSci Capital.
Jacques Villefranc
I was wondering whether you could elaborate more on the positive policy coverage with the national benefits company.
Valerie Palmieri
Sure, Jack. Thank you for the question. So the national medical benefits company is a third-party endorsement, which is stating that OVA1 is a medically necessary for the management of women with the adnexal masses to assess the risk of ovarian cancer, so it's a third-party endorsement. And what's happening is that as molecular technology becomes more widely adopted, managed-care companies and payers are utilizing third-party companies to assess clinical policy. And this particular national benefits company is assessing clinical policy for those plans that we mentioned. So we believe this is the start of our plans taking on positive medical policy and there's more to come in time as well.
Operator
[Operator Instructions] We'll go to [George Kafkarkou], Private Investor.
Unidentified Analyst
Can you just help me, you mentioned a top 10 pharmaceutical, that's the same reference as the last quarter, correct?
Valerie Palmieri
No, this is a brand-new one, George. So the last quarter that the one that we were referencing was specifically to the PTK7. This is another new pharmaceutical company that we are working with.
Unidentified Analyst
And I'm sorry if I don't understand that but thank you for clarifying it. What are we working on with this big top 10 pharma now that's new?
Valerie Palmieri
We are doing additional developments on PD-L1. So we are -- basically we've secured a -- our second large companion diagnostics study partnership and this will involve the further development of the immunotherapy PD-L1.
Unidentified Analyst
So now we're engaged with two top 10 pharmas, is that fair to say?
Valerie Palmieri
Yes, that is fair to say.
Unidentified Analyst
We talked to the few of you. I think I heard this coming out this quarter, did we signed it coming out this month or next month? Did we detail there?
Valerie Palmieri
It could be any day now, George, its -- we're waiting with bated breath. It could be any day now but we're, as I said, Marra went through the details, we're very excited. It is a landmark paper and we will be press releasing once its released, while we figured down the earnings call, we can at least speak to it. So we're very excited about that.
Unidentified Analyst
And can you just extrapolate and share with us all -- what you believe the consequences will be from that year review? How about...
Valerie Palmieri
So in simple terms, it is a large review of over 90,000 medical claims. And it's really looking at the total cost of managing both low-risked women and high-risked women, who are being assessed for ovarian cancer risk. And all the different procedures and -- that are -- basically a patient can undergo over a 24-month period a time. And because of the startling statistics of ovarian cancer being late stage, there's a lot of unnecessary cost, not only just for the high-risk patients but also the low-risk patients. So the study quantifies that patient's journey from start to finish from managing low-risk and high-risk. And just to give you an order of magnitude, in terms of maximum penetration and let's just say if a payer actually had utilized our test for 50% of their population that savings could be about $0.17 per member per month. And according that in terms of what that means on a PMPM or a per member per month, for a 20 million lives of payer plan that savings will be about $40 million at a 50% penetration. So another benchmark point for that too is if you compare data published with Fannie on Oncotype DX technology by Genomic Health, the savings there are seeing is anywhere from $0.03 to $0.05. And we're seeing, as I said, savings of up to 17% -- $0.17. So it's a market improvement and improving outcomes by reducing cost.
Unidentified Analyst
Yes, clearly, it's significant. So I guess one question is how does that factor and the other factors into your modeling for next year in terms of you ramp in the test volume. I mean clearly, one of the parameters of how our business is doing is the ramp and growth in tests the next year? I mean you got Q4, obviously, that -- and you've mentioned it that would be an increase. But how do you guys think about the ramping tests for 2018?
Valerie Palmieri
So as we allude to you in the call, we are investing in two specific expansion areas which we've already had, always expect. We are continuing the investments, but we are also now ready to start having dialogue with specific partnership. So -- and more to come on that but we didn't want to get too far ahead of ourselves, George. We had to get payer coverage price and guidelines and the wave volume will ramp, will be on our own organically but also working with the right partners through 2018. And that also ramps not only in the U.S. but also we are seeing -- now that we're ready for specific partnership discussions, even ex-U. S. So it's combination of getting our homework done and our hard work, our heavy lifting done first before we could actually sit down and really have a -- the best discussions that we could leverage with partners.
Unidentified Analyst
Okay, the final question for now and I'm sorry I have so many questions.
Valerie Palmieri
That's okay.
Unidentified Analyst
How would you articulate the progress in the United Kingdom?
Valerie Palmieri
I will articulate it as there's a major problem there, but I don't know whether there's solving where the root cause of the problem is. So I think that we are in dialogue and as I said -- they have a major ovarian cancer dilemma, but I do think that there is additional variables that we want to see lined up in the U.K. as well and there's more to come. So it's a -- we're continuing the discussions, I think there's a huge need there, George, without a doubt. But I also think that there's some things that we want to get lined up first before we would actually launch in the U.K.
Operator
We'll now hear from John Grimley with TJW Capital.
John Grimley
And you touched on this in the call and I think George maybe touched on a little bit as well. I just want to understand where we are as far as profitability? Based on the current pricing or expected pricing, how many tests we need to do on a quarterly basis to become profitable? Obviously, that would be a big milestone for you company, I just want to have a better understanding of that.
Eric Schoen
Well John, I'll start there. Obviously, we've made a lot of progress on our average unit price. And we think we've got a long way to go, particularly, with this boost, if the PAMA preliminary rates go final. But if you just wanted to order a magnitude and you kind of have to put IVD revenue and profitability on the side, if we ran 20,000 tests at a $500 AUP, we believe we could be a breakeven business, that's sort of the line to understand. Beyond that, that could be a combination of even fewer tests than that. In a greater AUP, you could add IVD service revenue. But as you know, we just don't give long forward guidance.
John Grimley
And what about the competitive landscape, from ROMA are any of those, I would love to know what you guys are seeing?
Valerie Palmieri
Yes. So in terms of competitive landscape, we went into some of that on the call, whether you caught it. But we are the fastest-growing in ACOG guideline technology who is increasing market share and increasing positive policy coverage. So from a competitive standpoint, we have seen some major shifts leaning towards OVA1.
John Grimley
Got it. And can you -- you touched on this in the call, it's just surprising given you've gotten the guidelines, I know you're still knocking down some of the bigger pairs. What is going to lead -- in your opinion, what's going to lead to the tipping point for test acceleration? It's just surprising to me we're not seeing more test acceleration, given you guys were putting in the guidelines relatively recently?
Valerie Palmieri
Part of it, John is, and I don't know whether you caught it is that we still have -- so we still have the old Quest legacy territories, which we manage with a phone rep, right? And we did mention on the last call that we preannounced, we had a Quest legacy client bill customer. So there's losses on, I'll call it white spaces that we are actively offsetting and we will be filling those territories, but we didn't wanted to get too far ahead of ourselves because we want to get our price in order and our payers in order. So I do believe that now that we have guidelines, payer and price, because you have in the guidelines but if you're not payer and price, you got to get those two lined up and each one of them are fronts that are all lining together. We now are going to be investing in sales organically, it reps in those territories to offset that loss. So we are growing where we have feet on the street, where we don't have street is where we have seen more of the erosion.
Operator
And now I'd like to turn the conference back over to management for any additional or closing remarks.
Valerie Palmieri
Thank you, Catherine. To conclude, we are very excited about the establishment of a highly-value price for OVA1 and the major increase in covered lives. These accomplishments set the stage for a strong 2018. We are focused on our growth phase, which include sales and pair adoption, while diversifying our revenue channels with international and ASPiRA IVD. In parallel, we have laid the foundation for our one-of-a-kind pelvic mass repository, which is intended to be the core of our Big Data engine in pelvic mass portfolio. You've already seen some of the fruits with our risk of malignancy report, which combines the OVA1 result and ultrasound, and we expect to incorporate the Symptom Index online product into our offering in the near future. As we build upon our database, we plan to build upon our existing platform to not only change the way ovarian cancer is managed but also push early detection upstream and build a proprietary portfolio to manage pelvic mass conditions, which impact one out of every five women in the U.S. Our end goal is to serve a global market with strong proprietary science coupled with a 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.
Operator
Thank you. And again ladies and gentlemen, that does conclude today's conference. Thank you all again for your participation. You may now disconnect.