Aspira Women's Health Inc. (AWH) Q2 2021 Earnings Call Transcript

Aspira Women's Health Inc. (AWH 0.29%)
Q2 2021 Earnings Call
Aug 12, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to Aspira Women's Health second quarter 2021 conference call. My name is Shamali, and I will be your coordinator for the call today. [Operator instructions] As a reminder, this conference call is being recorded today. Leading the call today are Valerie Palmieri, president, and chief executive officer; Bob Beechey, chief financial officer; and Kaile Zagger, chief operating officer; and Dr.

Lesley Northrop, chief scientific officer; and Dr. Elena Ratner, global chief medical advisor, Clinical and Translational Medicine. After the prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to Aspira's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995.

Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the control of Aspira. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Participants are directed to the cautionary notes set forth in today's press release as well as the risk factors set forth in Aspira's annual report filed with the SEC for a description of factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I'd like to turn the call over to Valerie Palmieri, president, and chief executive officer.

Valerie?

Valerie Palmieri -- President and Chief Executive Officer

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. This afternoon, we will review our second quarter accomplishments, financial performance, as well as provide an update on our overall strategic developments. Our end in mind is to truly transform women's health, starting with ovarian cancer.

Our goal is to eradicate late-stage detection of ovarian cancer and ensure all our solutions will meet the needs of women for all ages, races, ethnicities and stages of disease. We seek to develop a lifelong relationship with each patient from puberty to cure, ensuring each woman has access to the best-in-class diagnostics. Let me begin with a review of our core business. We are pleased to announce the growth of our revenue and volume despite COVID-19 restrictions.

We reported second quarter OVA1 only revenue of $1.72 million, an increase of 136% over prior year and 21% sequentially. Our OVA1 product volume was 4,553 tests, which is up 85% compared to the same period last year and up 21% sequentially as well. This impressive outcome was driven primarily by growth of our customer base, where strong commercial execution was bolstered by increased access to our physician customers as well as a reflection of the initiation of our sales force expansion in Q2. Regarding our decentralized platform Aspira Synergy, we are making progress, and the interest level is very high as we have several deals in the pipeline, more to come on this front.

I will now provide an update on a number of strategic developments regarding our pipeline, payer and evidence development, government affairs, and the additions to our senior leadership team. Before I move on to the pipeline, we have a significant paper that was just published this week, and we'd like to discuss upfront. The paper titled Salvaging Detection of Early Stage Ovarian Cancer Malignancies When CA125 Is Not Informative has been published in a special ovarian cancer edition of diagnostics. It is a 2,300 patient retrospective study to evaluate the performance of OVA1 in a cohort of patients with low-risk serum CA125 values.

This study demonstrates the ability of OVA1 to identify early stage disease, while CA125 reflected 0% sensitivity due to the low-risk cutoff. This paper further validates and supports the superior early stage detection of ovarian cancer with OVA1 versus the current standard of care in a large population. Dr. Ratner will be discussing this in detail later in the call.

Now starting with our pipeline, I will review our EndoCheck breakthrough device program application. We continue to have a positive dialogue with the FDA regarding our planned EndoCheck product. In addition, we are very pleased to announce that we have signed a specimen collaboration agreement with our second pharmaceutical company, AbbVie. AbbVie is pursuing new treatments for endometriosis pain.

We believe the specimen collaboration will advance our overall endometriosis research. Having two pharma companies contribute specimens, demonstrates the critical need for a diagnostic. This collaboration between AbbVie and Aspira represents a mutual dedication to create solutions to help the six million to seven million women suffering with endometriosis by radically improving the time to diagnosis as today, it may take seven to nine years for a diagnosis. EndoCheck will allow patients to be treated appropriately and effectively without the need for an unnecessary surgery.

We are in very productive communications with the FDA regarding our breakthrough device program application. Importantly, the FDA has acknowledged that there are many compelling reasons why this type of device is needed for both the treating physicians and for patients. The FDA has indicated they are very interested in continuing to work with Aspira on EndoCheck, and Aspira will be continuing our discussions with the agency on breakthrough device designation. I am now moving on to our second pipeline update regarding our OVAInherit product and collaboration with Dana-Farber Cancer Institute, Harvard.

We are making very positive progress on our product collaboration with Dana-Farber Cancer Insitute, which we disclosed in the first quarter. We expect to have data at the end of third quarter. Dr. Northrop will discuss this further in her section.

Regarding our payer and evidence development, we have three major updates. No. 1, first is the coverage of OVA1 in the AIM Specialty Health Laboratory Medicine Clinical Guidelines. OVA1 is now considered medically necessary according to the Aim Specialty Health clinical appropriateness guidelines.

Notably, they have not included a competitive product called ROMA in their guidelines and consider investigational and experimental. AIM is a member of the Anthem Blue Cross Blue Shield family of companies, which promotes optimal care through the use of evidence-based clinical guidelines and real-time decision support for both providers and their patients. AIM is a wholly owned subsidiary of Anthem, serving more than 50 million members across 50 states, including DC and U.S. territories.

This represents an opportunity for an incremental $50 million increase to our total covered lives. We have commenced a targeted program to obtain contractual coverage with all of the AIM member plans. Moving on to No. 2.

We also recently obtained coverage determinations from Highmark, Delaware as well as Fidelis, New York, with contracts pending for both. In addition, we continue to gain traction with Medicaid and are now being paid by California Medicaid. Our payer adoption strategy is making significant progress, and we believe inclusion in the AIM and Evicore guidelines gives us further validation and credibility in our discussions with all health plans. Moving on to No.

3. On the evidence development front, we released our first analytical and initial clinical validation performance for OVASight at ASCO 2021. OVASight is a third-generation OVA technology and is a laboratory-developed, blood-based pelvic mass risk assessment test for ovarian cancer in a low prevalence population. It was developed to increase specificity while maintaining high sensitivity with early stage and allow for conservative management of women with a suspected benign mass who are not recommended for surgery.

A total of 596 patients were tested from real-world patients to validate the OVASight diagnostic algorithm. Validation data demonstrated 91% sensitivity, 89% specificity, and a negative predictive value of 99.6%, and a low prevalence population of 3.8%. In addition, clinical sensitivity for all stages of disease and more importantly, early stage sensitivity was significantly better than CA125 as well. I am now moving on to the government affairs front.

We are continuing to gain momentum post our congressional briefing. The company is actively engaged with Congress in several advocacy organizations, including healthy women, the national ovarian cancer coalition and the ovarian cancer research alliance and an effort to increase awareness about OVA1, ovarian cancer and encourage legislation that provides financial support for additional trials. This also includes starting the discussions on the trial requirements for adding the company's ovarian cancer technology into guidelines, such as the U.S. Preventative Services Task Force, which would support the company's objective to launch a product that is more broadly applicable as a screening tool.

The company will also be presenting to a congressional committee in September focused on women's healthcare access issues. In addition, the company is also working on the Medicare innovation technology initiative to ensure coverage and reimbursement immediately following breakthrough approval for any of its products. And lastly, we have made significant addition to our leadership team. Laura McPadden joined the company as Head of People and Culture.

People are the core of our innovation and growth engine. Laura joins us with over 25 years experience, leading human resources and talent engines and providing strategic guidance for employee relations, performance management, talent acquisition, and organizational design. Before I turn the call over to Kaile to provide a commercial update, we are reaffirming the investment in sales and marketing and our investment in our pipeline. Our target launch date of OVASight is on track for a fourth quarter of 2021 launch.

This test initially will allow physicians to assess benign pelvic masses, not recommended for surgery with much better performing technology versus CA125. While our next revision of this technology will allow a mass to be monitored over time. This new test will leverage its high negative predictive value to assist in rule out, as well as its high PPV to assess risk of malignancy. In summary, we continue to work toward our overall strategic goal, which was to emerge from the pandemic stronger, and we believe we will continue to accomplish this, irrespective of any resurgence in the COVID pandemic.

We have had a faster than expected recovery with a limited sales force coming into Q2 as well. Our team is now stronger on all fronts with a solid financial position, plus improved price appreciation year-over-year, and our development pipeline has matured with our third-generation product expected to launch in Q4 2021. We are well positioned to invest, to grow and to drive adoption, and most importantly, save lives. I would now like to turn the call over to Kaile Zager, our chief operating officer.

Kaile?

Kaile Zagger -- Chief Operating Officer

Thank you, Valerie. As Valerie mentioned, we are pleased with our revenue and volume progress in the second quarter. I will now provide an update on our overall commercial progress. We are continuing to execute on our overall commercial strategy with meaningful additions of talent based on the complexities of the patient's journey through the health ecosystem, coupled with the convoluted presentation of ovarian cancer.

We have expanded and are deploying across our three direct sales channels. In support of these three verticals, we have invested additionally in critical support functions that will allow for rapid acceleration and adoption of our products into the clinical care pathway. Those supporting functions are commercial activation, enterprise integration solutions, and business analytics. We have aligned our strategies with the consolidation of the health systems and providers and the transition to the digital health in preparation for our much-anticipated launch of OVASight.

We are now also very focused on the establishment and development of our marketing and customer experience organization. We are thrilled to welcome an acclaimed marketing executive, Jennifer Van Aken to the organization to build and lead our marketing organization. Jennifer comes to us with deep CPG, healthcare, and private equity marketing experience, and in under just two months, have made significant strategic progress, commercial achievements, and key talent acquisitions within the organization. Starting with our core vertical.

It had strong performance in Q2 with our three key metrics outperforming historic performance of the company. The team delivered unprecedented record volume and total customers. The total number of ordering physicians in the second quarter was 2,951, an increase of 65% over prior year and 14% sequentially. Our new customers were up 69% compared to the same period last year and up 7% sequentially.

Q2 was the strongest quarter the company had seen across all drivers, accessions, revenue, and ordering physicians. Regarding our health systems team, which we originated in March of this year, we have scaled it to six sales representatives as of July, and they are establishing a deep funnel of health systems that we are actively working with to transition the standard of care and by directionally integrate our solutions into the electronic system, which should allow for the ease of ordering and standard of care adoption across the network. We expect to be able to announce wins in this area in the third quarter. And lastly, our specialty force focused on our decentralized platform Aspira Synergy, has executed a second agreement since product launch in Q1.

This agreement will be announced shortly. In addition, we are in final stages of approval with the third agreement which is one of the largest health networks in the United States. We believe that arrangements like this will form the fundamental building blocks to truly change the standard of care. Finally, the fundamental key to our strategy is the commercial activation activities that are fueling our sales force support functions, namely marketing, business analytics, commercial activation, and the insourcing of enterprise implementation and solutions team.

I will now review high-level achievement of each of these teams. First, our marketing function has implemented a myriad of new commercial strategies, including the launch of multiple programs that reached over 300 new physicians in seven weeks, double the span of our digital and social media reach, and developed cutting-edge campaigns that penetrate the Medicaid and Medicare market adoption, resulting in four large new ordering physicians with practices focused on Medicaid. We believe increasing awareness around ovarian cancer, signs, and symptoms and the fact we have strong differentiators for early detection, specific ethnicities and insurance coverage are all critical factors in driving adoption at the provider and patient awareness level. Visits to our website have more than doubled from a year ago and followers on Aspira's major social media platforms have increased year-to-date by double digits.

In addition, we were present at ACOG and SGO held virtually in 2021, and we presented our OVAight abstract at ASCO in June, which will be further discussed by Dr. Northrop later in the call. Our enterprise implementation and solutions team have rapidly expanded and is comprised of highly talented system engineers and industry experts in the digital informatics space. This team is working closely with our core synergy and health system verticals to build bidirectional integration interfaces to ensure we are well positioned to displace the standard of care and move the market toward a better solution for early detection of ovarian cancer.

In summary, we have invested in our growth strategy by constructing deployment models, formulating very strong go-to-market positioning, and are now well positioned to capitalize on acceleration and adoption. We have increased the size of our growth organization by 75% since January of this year and continue to scale in preparation for the OVASight launch in Q4. Specifically regarding sales, we started the year with 15 sales representatives in our core verticals, and we now have 35 sales representatives across three sales verticals. Within these verticals, the majority of the representatives to name 20 of them were hired in the last three months.

We truly believe we are positioned to accelerate adoption across the healthcare continuum while driving growth and delivering a stellar customer experience. We have an innovative portfolio of products that solve for an unmet need for a large population of women. And we are now prepared to mobilize and change the standard of care. I would now like to hand the call over to Dr.

Elena Ratner to provide an update on our momentum to becoming the standard of care and driving awareness of our technology and its impact on early stage risk detection of ovarian cancer specifically.

Elena Ratner -- Global Chief Medical Advisor

Thank you, Kailie. As a position, education, awareness, and adoption are key to changing the standard of care. We have had several milestones in this quarter. We continue our utmost commitment to provide awareness and education.

We have hosted multiple successful, highly attended dinner educational series and are currently launching GYN and GYN Oncology Advisory Board directed at better management of total masses and improvement of ovarian cancer early detection. Regarding clinical studies under my leadership, we are continuing to recruit more academic sites to support both the clinical validity and utility of our tests. We have also launched our physician-initiated research program for healthcare systems. This program provides nominal funding for projects that help fuel clinical implementation and adoption of ovarian cancer risk assessment tool and allows us to continue to expand our data repository.

I'm incredibly excited about the direction our clinical studies have taken, and we are continuously building our study program to strengthen the data around our products. And lastly, I would like to report a major update on a significant paper, which was accepted and published as of August 10th. It is an evaluation of the performance of OVA1 in a cohort of patients with normal serum C125 values that was accepted to the special ovarian cancer addition of Diagnostics. Under a revised title, salvaging detection of early stage ovarian malignancies when C125 is not informative.

In this publication, we analyzed 2,300 patient data from previous collections with a prevalence of 4.5%, where C125 levels were in the normal range, depending on the age of the patient, which is less than 67 units per milliliter for pre-menopausal women and less than 35 units per milliliter for post-menopausal women. Of most importance, we demonstrated that in those women's OVA1 detected over 50% of variant malignancies in pre-menopausal women that C125 would have missed. OVA1 also correctly identified 63% of early stage cancers missed by C125. As a stand-alone test, C125 misses more than 50% of ovarian malignancies that can be detected by OVA1 in both early stage cancers and pre-menopausal women, which have a much better long-term survival if detected early.

Speaking of the clinician, who constantly loses women ovarian cancer that is diagnosed at advanced stage, finding and treating the cancers early will change the paradigm of this disease. I would now like to hand over the call to Dr. Northrop to provide an update on our innovation pipeline.

Lesley Northrop -- Chief Scientific Officer

Thank you, Dr. Ratner. I would like to provide an update on our overall innovation pipeline. We continue to build out and support our current products with publications focused on clinical validity and utility of our current product, OVA1 Plus.

More specifically, we have two recently accepted publications, one which Dr. Ratner just discussed and the second which is an update on our OVA1 Plus technology. The paper was accepted to the International Journal of Biological Markers titled: " A two-step Multivariate Index Assay Improves the Accuracy of Ovarian Cancer Risk Assessment for Women With Adnexal Mass. It is expected to be published at a future date.

This paper highlights an orthogonal laboratory reflex called OVA1 Plus that benefits patients who are not readily stratified as lower high-risk using OVA1 alone and classify as intermediate. The Overa is employed in these cases and allows for a higher specificity. This study was validated in over 1,000 prospectively collected retrospectively analyzed serum sample data set in a prevalence of 22% and further verified using an independent data set of 207 with a prevalence of 40%. 35% of the samples were defined as intermediate risk by OVA1 test and reflex to Overa, which eliminate 58% of the false positive and improved the overall specificity to 72%.

Overa reflex testing of samples, which have an OVA1 intermediate risk score decreases the false positive rate, thereby reducing the number of unnecessary surgical referrals without notable reduction in clinical sensitivity. We expect that we will have more publications to announce in the coming quarters. I would now like to provide an update on our upcoming products and enhancements. First, let me reiterate my optimism for EndoCheck.

As Valerie mentioned, we are having a productive dialogue with the FDA. While we cannot disclose our sensitivity and specificity of the test performance, while FDA discussions are ongoing, we are pleased with our data relative to the current standard of care, laparoscopic surgical assessment. We are working on updating our submission to the FDA based on their guidance, meet breakthrough designation doing endometriosis is in an irreversible debilitating disease. We are also excited to boost our specimen bank of endometriosis cases as diagnosed by laparoscopic surgical assessment, with the collaboration agreement we just announced with AbbVie as it will assist in our future refinement of the EndoCheck product.

I would now like to provide updates on OVASight. We continue to be on track for our accelerated launch of OVASight this fall. The analytical and initial clinical validation of OVASight performance metrics was presented in an ASCO poster presentation on June 4th this year. The accepted abstract presents data demonstrating the initial clinical and analytical validity of Aspira's OVASight, blood-based biomarker test for ovarian malignancy risk assessment in all women with an adnexal mass.

Samples collected from real-world evidence studies with a low prevalence of cancer, 3.8%, were used to validate the algorithm. This third-generation technology, which is a laboratory developed test, will provide clinicians with a high negative predictive value to provide confidence in planning a suspected benign mass monitoring plan as well as a greater positive predictive value to increase confidence in risk of malignancy and next steps in clinical management. The product is expected to be available in Q4 of 2021. In addition, a peer-reviewed publication on both the analytical and clinical validation findings are scheduled for Q4 of 2021.

I would like to now give an update on OVAInherit. We are working on building a robust recruiting program in high-risk populations, such as family history personal history, and/or germline carriers of highly prevalent hereditary breast and ovarian cancer genes as well as diverse populations across racial ethnicities to increase our study cohort to support the OVAInherit test design. Our proof-of-concept study with Dana Farber Cancer Institute in Harvard is progressing nicely, and we expect to have preliminary data at the end of Q3 2021. The goal is to combine our high sensitivity performance as reported with OVASight with a high specificity by detecting micro RNA and serum to provide a multi-omics approach that can help eradicate late-stage ovarian cancer detection.

Multi-omic technology will allow us the opportunity to develop the diagnostics and eventually screening technology that we desperately need to increase a woman's survival rate when faced with an earlier diagnosis of ovarian cancer. Now moving on to clinical studies. One of our primary efforts in innovation in these past two quarters is to enhance our clinical studies and enrollment despite COVID-19 restrictions. We are continuing to recruit larger academic institutions in clinical practices to allow us to collect from a comprehensive cohort of women across all races and ethnicities and continue to enhance our product development pipeline.

We continue to develop data metrics for these large academic institutions through our clinical studies as well as already established technologies validated for the detection of ovarian cancer. In summary, with our product pipeline, you will begin to see we're building a lifetime relationship with the patient. This is our OVA360 approach in providing a circular loop of products to better women's health. We are developing products that can start as early as menses with EndoCheck allow early detection risk of hereditary cancer with genetic hereditary cancer testing, monitoring of high-risk women with OVAInherit and until later in life, in a population of a background risk of 1.3% for ovarian cancer with no heritable detection, OVA1 Plus and OVASight.

And we look into the future in developing residual risk assessments as well as reoccurrence monitoring and eventually therapeutic clinical diagnostic testing. Innovation is the core of our strategy. Our goal is to invest and accelerate our evidence development and pipeline and surround it with strong IP as we maximize shareholder value. I will now turn it over to Bob for an update on our financials.

Bob Beechey -- Chief Financial Officer

Thank you, Dr. Northrop. We reported second quarter OVA1 revenue of $1.72 million, an increase of 136% over prior year and 21% sequentially. The 136% product revenue increase is primarily due to the lower number of tests performed in 2020 due to COVID-19, as well as an increase in OVA1 average revenue per test in 2021 compared to the prior year.

The revenue per OVA1 Plus tests performed increased to approximately $377 compared to $375 for the first quarter. The year-on-year price increase was 28% compared to the prior year second quarter of $295. This increase was primarily driven by an increase in payments by contracted payers and improved collections. While we have made progress with payers in the second quarter, we take a conservative approach to revenue recognition and do not recognize the revenue until we establish a track record of payments received.

Gross profit margin of OVA1 Plus was 52% in the second quarter compared to 54% in the first quarter of 2021. The decrease was primarily driven by nonrecurring costs associated with the switch in our kit assembly vendor, which will result in a lower cost per unit in the future. Gross profit margin on OVA1 Plus increased from 37% to 52% compared to the second quarter of 2020 as we leverage our fixed costs with the increased volume. Research and development expenses for the three months ended June 30, 2021, were $1.47 million, an increase of $599,000 or 69% compared to the first quarter of 2021.

This increase was primarily due to clinical utility and product development costs related to OVASight, our third-generation product, as well as investments in bioinformatics, Aspira Synergy, and consulting expenses associated with EndoCheck regulatory clearance. The second quarter spend represents an increase of approximately $1 million compared to the second quarter 2020 spend as we've made investments in personnel, focused primarily on OVASight and EndoCheck. Sales and marketing expenses were $4 million for the three months ended June 30, 2021, an increase of approximately $900,000 or 29% compared to the first quarter of 2021. The increase was primarily due to increased personnel and consulting costs as we execute upon the commercial strategy previously discussed.

The prior year sales and marketing expense of $1.7 million was depressed due to lower travel and entertainment and commissions and did not reflect the current investments we are making in market awareness and the sales team additions. General and administrative expenses were $3.3 million for the three months ended June 30, 2021, an increase of approximately $793,000 or 32% compared to the first quarter of 2021. The increase was primarily due to an increase in headcount and personnel expenses as well as stock compensation expenses. We incurred $1.9 million in general administrative expenses in the prior year quarter.

We ended the second quarter with approximately $53 million in cash. Cash used in operations in the second quarter of 2021 were $6.4 million compared to the first quarter of 2021 of $5.2 million. The increase was driven by investments in the sales team, marketing and promotional activities as well as research and development spending focused on EndoCheck. I will now turn the call back over to Valerie.

Valerie Palmieri -- President and Chief Executive Officer

Thank you, Bob. Before we open up the call for Q&A, let me restate our optimism for building the company for sustainable growth for the near term and the long term. In parallel, we are executing on our larger mission to serve the 20 million women in the U.S., starting with ovarian cancer risk assessment, pelvic mass monitoring and eventually tackling the largest disease endometriosis. Keep in mind our hereditary ovarian cancer monitoring test, OVAInherit, will be incremental to this market, and this product will be for women with and without a mass.

Ovarian cancer accounts for more deaths than any other cancer of the female reproductive system and is the only gender-specific cancer with greater than a 50% mortality rate. Our work in products are at the forefront of changing the standards of care and detection of ovarian malignancies. We believe we are helping close the gap in detection and, more importantly, survival for women. In the near term, we believe OVA1 Plus with our diversity differentiation and genetics will become the standard of care in pelvic mass risk assessment for ovarian cancer, and we are now moving forward with the launch of our third-generation OVASight technology for benign mass management in Q4 2021.

For the longer term, we are moving forward with our planned launch of EndoCheck for endometriosis; and lastly, OVAInherit for high-risk genetic predisposition monitoring. Our end in mind is the incorporation of proteins, genes, and other modalities to detect gynecologic disease, which cannot be detected via traditional biopsy. In time, our goal is to become the liquid biopsy standard for these diseases, inclusive of all ages, stages, and most of all, all ethnicities. With our enhanced team, strengthened financial position, and our robust portfolio, we could not be more confident across the business.

It is now time that all women of every race and ethnicity receive the best care possible, and we are proud and excited to help make that happen. We are now happy to open up the call for Q&A and answer any of your questions. Operator?

Questions & Answers:

Operator

[Operator instructions] And our first question is from Brian Weinstein with William Blair. Please proceed with your question.

Brian Weinstein -- William Blair & Company-- Analyst

You guys certainly have a lot going on. And so trying to come up with a couple of questions that are targeted. But on OVASight, obviously, the Q4 launch is great. Can you talk a little bit about how you're preparing the organization for that? I think I heard something about a digital health program there.

Can you talk about what that is? And then also as it relates to OVASight, how should we be thinking about price point here? I think you had made some comments about that previously, but just wanted to confirm the price point there and your plan for payer outreach on that product?

Valerie Palmieri -- President and Chief Executive Officer

Sure. Thank you for the question. So I'll start, and then I'm going to let Kaile Chime in. So with OVASight, because the market size for OVASight is three times that of OVA, so we are launching OVASight in all of our verticals in terms of the GYNs as well as the hospital market in the future, it will also be a synergy product as well.

So our go-to-market with this -- and we're also -- I want to say, with this COVID environment, we have gone with a parallel path, both with accessing the physicians, which is actually going fairly well, and also, what I want to say is a virtual approach as well. So it's a twofold approach. But I -- but we're really pleased about the progress. We have brought in some, I want to say, outside consultants from a creative standpoint to really help us launch this from a continuing medical education to ensure the reps have the right information in their tool belt to also, I want to say, doctor to doctor because this is really, we believe, the answer the doctors have been looking for in terms of how they have been wanting to use OVA.

But I'm going to have Kaile go into details in terms of the physical launch and how we are readying the sales team.

Kaile Zagger -- Chief Operating Officer

So I'll go into a little bit of the commercial design of what we've constructed in preparation for the OVA site launch. We have -- as we mentioned, we've increased our commercial organization, the sales book specifically by 75% since January. And this is really to address the fact that OVASight is going to tackle the entire continuum of the patient with pelvic masses. So one in five women will have a pelvic mass in their lifetime.

And we now have a solution to address the beginning of those pelvic masses when they might be benign and not scheduled for surgery, all the way to the most complex. As Valerie mentioned, the total addressable market goes up significantly when we're looking at all of those pelvic masses. And in order to make sure that we have the proper footprint commercially, we have -- we're really focused on putting salespeople where it matches the ICD10 diagnosis. So we've studied exactly where those high-volume of pelvic masses exist.

We have been very focused on placing sales reps in those specific geographies. And then to couple on top of that, we are hard at work on a digital strategy to ensure proper education of not only the providers, but the patients on pelvic mass awareness in those respective areas. So we've got very targeted campaigns and approaches, whether it's through web or social or web search and Google to ensure that we've got proper education that we're effectively priming the market before launch. I hope that answers your question, but I'm happy to take any further.

Brian Weinstein -- William Blair & Company-- Analyst

No. That's great. And then just on the payer outreach side there for OVASight. How will -- how will you guys be working with payers here to generate adoption?

Kaile Zagger -- Chief Operating Officer

Sure. So OVA1 is really grease to skids with payers, Brian. So as we just received the AIM guidelines, it opens up the door for OVA watch or OVASight in a big way. So we're starting with a PMA code.

We are -- we basically have applied for a PMA code, and then we will also be applying for Medicare coverage and going down that road in parallel with the launch. In addition, we already have started our prospective study for clinical utility. So we've got the, I want to say, the IRB in process as well as we really want to do things in parallel fast so that we can get reimbursement as quickly as possible. So I think OVA is really grease to skids.

We're already priming the pump and getting the, I would say, renegotiations on the contracts where we have contracts, the inclusion of OVASight into those contracts. And as we brought on Board, Greg Richard from a managed markets perspective, we are adding resources because between the AIM and now OVASight, we really have quite a bit of work on the managed care side.

Brian Weinstein -- William Blair & Company-- Analyst

Great. And then on the synergy side, I'm just curious kind of what constitutes a large account? I mean, how do you guys bifurcate that market to figure out what's an appropriate synergy accountant? Can you remind us on the economics for you guys there versus having these tests run in your own lab? And then I guess that's it on the synergy stuff, and then I'll have one more after that.

Valerie Palmieri -- President and Chief Executive Officer

Sure. So let me start. In terms of the size of the account in terms of customer segmentation, what we really are looking at is 100-plus physicians being a very large health network. And these health networks is not just GYN focused.

There's some health networks that are actually primary care and GYN. So we are looking at 100-plus physician health networks. We've closed one, which we are actively implementing right now. And we have -- we're very close on several others.

We were hoping actually for them to hit this call, but we're close on several others, but it's really 100 plus. I will also point out on the genetics side, there is also interest at a laboratory level. So there's laboratories that are sending out their HBOC testing to, let's just say, a common HBOC provider, and they have the ability now to run it in-house. And then the second part of your question was the economics.

So the economics are, for us, is really depending on OVA or genetics. It is going to be at very high margins. So the total price, of course, is lower than us doing the OVA ourselves. But in terms of margins, it has high contribution.

And I think more importantly, its going to be the fact that these, especially on the CA125 side as well as the genetic side, it is a revenue opportunity for the customers, and it gives us access to the identified data. That's absolutely critical that we are getting data access is important for our algorithm development at the genetics level as well as at the protein level, and this will truly be a software as a service model.

Brian Weinstein -- William Blair & Company-- Analyst

Great. And then last one for me is EndoCheck. So can you just talk about the importance of the additional set of samples that you're getting? Are they different in any way than the samples that you were getting from your first partner in terms of makeup of the individual that is -- where the samples are coming from? Or is it just getting even more samples? And what is the kind of importance of getting these additional samples? Were you not getting enough kind of with your first partner? Or is there something broader here in terms of a potential longer-term relationship that you're trying to signal?

Valerie Palmieri -- President and Chief Executive Officer

Yes. No, it's a really good question. So these samples are from a second partner, AbbVie. AbbVie is trying to build a drug to compete, of course, with [indiscernible] with better safety profile.

And these samples are actually a different specimen type. They are plasma versus serum. And this does allow us to expand things from an analyte perspective as well as it is a more of a global population. So we're very -- we're really, really pleased about it.

And I would say also, in terms of AbbVie being a public company, you will see that actually they have actually canceled their trial in the U.S. because they were not able to recruit patients into their trial because the patients with Endo are not having surgery. So they truly need a diagnostic to complement that. So there is a high level of dialogue with this company and having two separate banks from two separate companies has truly been game-changing for us and really helps just bolster our overall endometriosis research.

Brian Weinstein -- William Blair & Company-- Analyst

OK. Thanks for the answers.

Operator

[Operator instructions] Our next question is from Charles Duncan from Cantor. Please proceed with your question.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Thanks Valerie and team. Congratuations on a good quarter of progress. Thanks for taking my questions.

I had a couple of questions. First, on the commercial side for OVA1. I guess you have very good test volumes, seems like nice sequential growth. When you think about how the tone of business is going into the third quarter, how do you feel about that growth, sequential growth? And then into the second half of the year, particularly with the Delta variant, I think you mentioned increased access for physician access.

And I guess I'm wondering how you feel the dynamics of the COVID pandemic could impact growth going forward?

Valerie Palmieri -- President and Chief Executive Officer

Sure. Well, thank you Charles for the question. So let me start, and I'm going to have Kaile actually jump in. So we came out of Q2 in the 4,500 range and really pleased.

And by the way, majority of our sales team members did not join until the back half of that. So we were really pleased with the Q2 performance coming in Q1 with 15 and taking up to 35. So going into Q3, each one of these reps really is going to have their first quarter of performance. So we have a larger footprint, No.

1. No. 2, our patients that are not being screened. So there's a sense of urgency.

They have a mass whether it's benign, they're still very worried, right? So they need to go to the doctor. So we are seeing, I would say, in Q3, we're seeing somewhat of a dip in a sense, but I don't think it's anywhere in terms of, just say, companies that are doing screening products. And we saw this during COVID. So the nice part is that during this process, we sort of are looking back at Phase 1 of COVID and saying, OK, what were the lessons learned? And one of the lessons that we had learned was that our technology actually was helping doctors bring patients to the OR when they're high risk and helping doctors manage patients that were low risk to actually say to them, look, we're going to do surgery, but we're going to wait 30, 60, 90 days.

So that same playbook is moving forward. But I would also say another piece of this is just the virtual element of this. We really have just everyone keeps on track of the news, although I saw some good data in the U.K. where Delta has surged and then actually decreased.

But I would say that we are preparing a plan A and a plan B. We're prepared with our larger footprint to not only get the access, but also we have a very well-integrated virtual program that I'll have Kaile go into in detail. Kaile?

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Great. Thank you.

Kaile Zagger -- Chief Operating Officer

Thank you Valerie. So to reemphasize Valerie's point, 20 of the 35 sales representatives that have joined the company joined in Q2. So most of them are out of training, and we expect somewhat of a lag effect through training, but that productivity will start to demonstrate itself toward the end of Q3. So right now, I am not concerned about the July and August numbers.

We absolutely are preparing and expecting September to be a strong month. But to Valerie's point, we are thinking very strong about the Delta variant and what we need to do with lessons learned from the first phase of COVID, and we are hard at work at redefining the commercial go-to-market with a bifurcated approach that incorporates innovative virtual approaches to ensure we continue to increase our penetration with new physicians and awareness with women. So to do that, we're deploying four new channels, and we expect to do this -- we've done some of this already, but we expect to continue and formalize in the next few weeks. One, we've rigorously focused on a digital marketing strategy.

A segmented approach around lots of different markets and has heavily invested in ensuring that we are educating through every digital channel that we can, and we've seen incredible uptick in this to the tune of double the amount of volume to the websites and close to those numbers on our social media. No. 2, we have put together a virtual commercial toolkit, our marketing team is hard at work constructing this. This is a toolkit that has six pillars that will allow our force to continue with their strategic plans virtually and effectively if necessary.

No. 3, we've invested very strongly in our physician-to-physician platform. So before we've had a modest number of physicians on staff, we've rapidly increased that number. And instead of relying just on our commercial organization to be out in the field and creating new physician relationships, we are now bifurcating that approach with physicians that are speaking directly to physicians on our behalf and creating a call to action around ovarian cancer and early detection.

And we've seen a lot of success in those peer-to-peer discussions. No. 4, we are actively involved -- as an executive leadership level within the company, looking at strategic partnerships with other organizations -- and this is an atypical approach in that. We're not looking at typical business-to-business relationships that with further research and development, etc.

We are looking at creating strong alignment with organizations that have the type of physicians that we want to access on their board of directors involved in their cause and a large base of patients that either care about the disease with ovarian cancer and want to help make an impact. And we have had very successful conversations in the past six weeks, and we're expecting to formalize some very important strategic partnerships that will work as a very strong adjunct to the commercial organization as we anticipate moving modestly to virtual. I hope that gives you enough granularity.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes, definitely provides a lot of good information. I guess just a follow-up. It sounds like fully increased size sales force full productivity in the -- and call it, the fourth quarter and then beyond, do you focus on new prescribers or new users more so than within a prescriber's practice? Or how would you define success going forward? Because I think Kaile mentioned 14% increase sequentially in terms of prescribers. And I guess, what would you like to see that?

Kaile Zagger -- Chief Operating Officer

So it's actually a great question, very timely for what we're looking at right now. So new physicians have always been a very strong metric within the organization, and we continue to be very, very focused on that. However, and simultaneously, we are also very, very focused on customer retention. And we have seen this be something that we want to work on going forward.

And I'm very happy to tell you that in the second quarter, we've seen some incredible numbers with retention come up and stickiness within customers be created. But this is just the beginning of what I think you can expect to see from us. We're very focused on building a customer experience division and translating our -- what now is the customer service division into more of an experience and doing some work to retain and increase our footprint within the physician practices that we have worked so hard to get on board and looking at expansion plans, land and expand plans inside of those practices. But the big focus that we have right now is on ensuring we understand where retention problems might exist, how to rapidly fix those, address them, bring them back into the fold, and continue to move down this road with them.

So I expect to see the new position percentage continue to increase, but that continues to be our big focus. But simultaneously, you will see our inside sales force and our customer experience team, work to increase our customer retention, create a wonderful customer experience and create stickiness within our important customers.

Valerie Palmieri -- President and Chief Executive Officer

Yes. Just to piggyback on that, Charles, it's also within a customer, we want to get -- so if a practice has 10 physicians, we want to land all 10 and keep all 10. So I want to make sure you understand that piece, too. So it's usually the friendly or the first physician that starts, but then it's going through that whole practice.

Extremely important to -- as we close these large practices that are 100-plus physicians. So it's getting that 80-20 from those practices, and that's a different cell process, as you know, but it's that continuity and that maintenance is also very important. And as Kaile pointed out, with the inside sales force, and once that we have some service reps in certain territories, but it's really, I want to say, a multi front approach as we build the products within that customer and also the retention within that customer.

Charles Duncan -- Cantor Fitzgerald -- Analyst

You feel like you're at sufficient capacity now? Or would you anticipate in the next, call it, 12 to 18 months some additional hires in the sales force?

Valerie Palmieri -- President and Chief Executive Officer

Well, I think with EndoCheck, that market is 20 times over. That's going to take us to a whole another hemisphere. So right now, we're at about 35. We'll probably go up to about 40, whole tight through OVASight.

This is really prep for OVASight. So we can really get that market being adopted. But with EndoCheck, there will be growth in the sales force as well as, I would say, strategic partnerships as well in parallel because of the size of the market.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Can I ask you one last question since you brought up EndoCheck and I know you're not going to be able to be all that disclosive given discussions with the agency, but you mentioned sensitivity and specificity and pleased that you will exceed that of endoscopy, surgical assessment. But I guess, beyond just talking about certain numbers, I'm wondering how you would see a clinically meaningful improvement. It seems like your EndoCheck is much more convenient or fast all than endoscopy. So do you need a big change in terms of sensitivity or specificity to be clinically valuable or even a small change would be compelling? And then I know this one is really difficult.

But with regard to timing of those FDA discussions, can you provide any color?

Valerie Palmieri -- President and Chief Executive Officer

Sure. So let me just walk you through. It's not a complicated answer, but this is on multi fronts EndoCheck will make a difference. I'm just going to walk through pain, delay in treatment in the major -- just the care pathway, to start with pain, what EndoCheck will provide is immediate disease detection, right? So a patient may try OCPs or NSAGs, Motrin, etc., but it will basically supply immediate detection because of the high sensitivity and specificity, and that will allow medical therapy immediately.

And we believe, potentially avoid surgical intervention, but it avoids this trial and era of medical management. The second is, right now, endometriosis takes seven to nine years based on the latest data. And so what we will do is eliminate that delay in diagnosis, really hault the disease progression if the therapy is put in place and improve the quality of life by reducing time to treatment. The other piece is exploratory surgical intervention.

We can avoid surgery that's unnecessary, right? Only perform at if it's clinically warranted. And I would say the last piece is really when the GnRH antagonist is actually therapeutically administered, this will prevent the delay, of course, in treatment. Prevent the delay in major disease progression. And again, I think, in summary, some major improvement in quality of life because right now, the current process is not in the best interest of the patient, and that is very important to the FDA.

I will also say with the FDA, we're going up against mostly, I'd say, oncology changes, so oncology diagnostics and oncology breakthrough. What we are doing here is really novel in that we are taking about nine disease, and really, I would say, there's an education process, but putting it right out in the open. And it's not only us presenting to the FDA. It was experts on all different facets.

But having them truly understand that it is a irreversibly debilitating disease so I would say the conversations, Charles, have gone very well. The fact that we are in dialogue and it's breakthrough because they're giving you advice as you're building your, I want to say, your protocol and recognizing that this is uncharted territory and there's no predicate device. So they're really working with you. So the fact that they see there is a problem, the fact that they see that we've gotten a lot of great feedback, I do believe that there is a partnership here.

So things are going well.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Thanks for taking my questions.

Valerie Palmieri -- President and Chief Executive Officer

Our pleasure, Charles.

Operator

And we have reached the end of the question-and-answer session. I'll now turn the call over to Valerie Palmieri for closing remarks.

Valerie Palmieri -- President and Chief Executive Officer

Thank you, operator. In closing, we believe that our accomplishments during Q2 set us up nicely for the second half of 2021 and beyond. We are focusing on doing the right things to drive sustainability and growth. With our increased commercial footprint, strengthened balance sheet and a guideline endorsed and differentiated test, a differentiated portfolio test within the same call point, and now we're at 54% of the lives under coverage in the U.S., we believe we are in a position to support continued growth and profitability.

Our end goal is to serve a large global public mass population and overall women's health market with a platform coupled with proprietary science and data tools, which will better serve and improve better health and well-being to each and every patient we serve. Thank you for joining us today, and we appreciate your support and interest in Aspira Women's health.

Operator

[Operator signoff]

Duration: 61 minutes

Call participants:

Valerie Palmieri -- President and Chief Executive Officer

Kaile Zagger -- Chief Operating Officer

Elena Ratner -- Global Chief Medical Advisor

Lesley Northrop -- Chief Scientific Officer

Bob Beechey -- Chief Financial Officer

Brian Weinstein -- William Blair & Company-- Analyst

Charles Duncan -- Cantor Fitzgerald -- Analyst

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