Q2 2021 Aspira Women's Health Inc Earnings Call

[music].

Good afternoon, ladies and gentlemen, and welcome to aspire walking women's health second quarter 'twenty 'twenty. One conference call. My name is Somalia, and I will be your coordinator for the call today.

At this time all participants are in a listen only mode.

Following managements prepared remarks, we will open the call for your questions. As a reminder, this conference call is being recorded today.

Leading the call today are Valerie Palmieri, President and Chief Executive Officer, Bob <unk>, Chief Financial Officer, and Calzaghe, Chief Operating Officer, Dr. Leslie Natera, Chief Scientific Officer, and Dr. Lena Ratner Global Chief Medical advisor clinical and transit translational medicine.

After their 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 this.

As 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 90.95.

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.

Certainties and could differ materially from those anticipated due to the impact of many factors beyond the control of the sphere.

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 note set forth in today's press release as well as the risk factors set forth in the Spirit annual report filed with the S E C.

Description of factors that could cause actual results to differ materially from those anticipated before looking statements at this time I'd like to turn the call over to Valerie Palmieri, President and Chief Executive Officer salary.

Thank you operator, good afternoon, everyone and thank you for joining us today.

Afternoon, we really view, 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.

Reported second quarter over one only revenue of 1.72 million, an increase of 136% over prior year and 21% sequentially.

Our other one product volume was 4553 test, 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 were 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, it's virus synergy we are making progress and the interest level is very high as we had 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 in evidence development.

Chairs 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. Once you went 25 is not informative has been published in a special ovarian cancer edition of diagnostics.

It is a 2003 hundred patient retrospective study to evaluate the performance of over one and a cohort of patients with low risk serum C 125 values.

This study demonstrates the ability of over one to identify early stage disease, well see you in twenty-five reflected zero percent sensitivity due to the low risk cut off.

This paper further validates and supports the superior early stage detection of ovarian cancer with over one versus the current standard of care and a large population.

Dodger Ratner, we'll be discussing this in detail later in the call.

Now starting with our pipeline I will review, our Endo check breakthrough device program application.

We continue to have a positive dialogue with the FDA regarding our planned endo check product.

In addition, we are very pleased to announce that we have signed a specimen collaboration agreement with our second pharmaceutical company that's either.

I believe is pursuing new treatments for endometriosis pain.

We believe the specimen collaboration will advance our overall endometriosis research.

Having to pharma companies contribute specimens demonstrates the critical need for a diagnostic.

This collaboration between I believe that inspire.

Ah represents a mutual dedication to create solutions to help the six to 7 million women suffering with endometriosis by radically improving the time to diagnosis as today. It may take seven to nine years for a diagnosis.

Endo check 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 a breakthrough device program application importantly, the FDA has acknowledged that there are many compelling reasons why this type of devices needed for both the treating physicians and for patients.

D. A has indicated they are very interested in continuing to work with the spiral on endo check and a spiral will be continuing our discussions with the agency on breakthrough device designation.

I am now moving onto our second pipeline update.

Regarding our Ova inherent product in collaboration with Dana Farber Cancer Institute Harvard.

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

Regarding our payer and evidence development, we have three major updates.

Number one first is the coverage of over one and the aim specialty health Laboratory medicine clinical guidelines.

Over one 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 considerate investigational and experimental.

AME 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.

AME is a wholly owned subsidiary of anthem, serving more than 50 million members across 50 states, including D C 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 remember plans.

Moving on to number two.

We also recently obtained coverage determinations from Highmark, Delaware as well as the Dallas, 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 and the aim and Evercore guidelines gives us further validation and credibility in our discussions with all health plans.

Moving on to number three on the evidence development front, we released our first analytical and initial clinical validation performance for oversight at <unk> 2021.

Oversight is a third generation Ova technology and as a laboratory developed blood based pelvic mass risk assessment test for ovarian cancer and a low prevailing 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 mask who are not recommended for surgery.

A total of 596 patients were tested from real world patients to validate the oversight diagnostic algorithm.

Validation data demonstrated 91 per cent sensitivity, 89% specificity and a negative predictive value of 99, 6% and a low prevailing population of three 8%.

In addition, clinical sensitivity for all stages of disease and more importantly, early stage sensitivity was significantly better than seeing 125 as well.

I am now moving onto the government Affairs front.

We are continuing to gain momentum post our congressional briefing.

The company is actively engaged with Congress and several advocacy organizations, including healthy women the national ovarian cancer coalition and the ovarian cancer Research Alliance and an effort to increase awareness about over one over there.

In 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 health care access issues.

In addition, the company is also working on the Medicare Innovation Technology initiative change their coverage and reimbursement immediately following breakthrough approval for any of its products.

And lastly, we have made significant addition to our leadership team Laura Mcfadden joined the company as head of people and culture.

People are the core of our innovation and growth engine, where joins us with over 25 Years' experience, leading human resources and talent engine and providing strategic guidance for employee relations performance management talent acquisition and organizational design.

Before I turn the call over to Kylie 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 oversight 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, which much better performing technology versus C. A 125.

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 and rule out as well as its high P. T V to assess risk of malignancy.

Okay.

In summary, we continue to work towards our overall strategic goal, which was to emerge from the pandemic stronger and we believe we will continue to accomplish that irrespective of any resurgence in the COVID-19 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 products 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 Kylie Zager, our Chief operating Officer Kiley.

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 journey through the health ecosystem.

Coupled with the convoluted present in Houston of ovarian cancer, we have expanded and are deploying across our three direct sales channels and supported these three vertical we have invested additionally, and critical support functions that will allow for rapid acceleration and adoption of our products into the clinical care pathway that we're supporting.

Functions, our commercial activation enterprise integration solution and business analytics, we have aligned our strategies with the consolidation of the health system and providers and the transition to the digital health in preparation for our much anticipated launch of oversight.

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 for the organization to build and lead our marketing organization.

Jennifer comes to us with deep C. P D healthcare and private equity marketing experience and then Andrew just a few months has made significant strategic progress.

Actual achievements and key talent acquisitions within the organization.

With our core vertical it had strong performance in Q2, but 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 2951 an increase.

That's 65% over prior year, and 14% sequentially, our new customers were up 69%.

Paired with the same period last year and up 7% sequentially Q2 was the strongest quarter. The company had seen across all drivers assertion revenue an ordering physician.

Regarding our health system team, which we originated in March of this year, we have scaled it to fixed sales representatives as of July and they are establishing a deep funnel of health system that we are actively working with them to transition the standard of care and bi directionally integrate our solution into the electronic system, which should allow for the use of <unk>.

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 aspire synergy has executed a second agreement since product launch in Q1 disagreement will be announced shortly.

Listen we are in final stages of approval with a third agreement.

Which is one of the largest health networks in the United States.

We believe that arrangements like this.

Well form the fundamental building blocks to truly change the standard of care.

Finally, the fundamental key to our strategy as the commercial activities and activities that are fueling our sales force support function, namely marketing business analytics commercial activation and the in sourcing 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 and seven weeks double the span of our digital and social media reach and develop cutting edge campaigns to 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 in insurance coverage are all critical factors in driving adoption at to provide.

And patient awareness level.

Visits to our website have more than doubled from a year ago and followers honest virus major social media platforms have increased year to date by double digits.

In addition, we were present at a cog and S. T O held virtually in 2021 and we presented our oversight abstract at <unk> in June which there'll be further discuss my Doctor Northrop's later in the call.

Our enterprise implementation and solutions team have rapidly expanded and it's comprised of highly talented system engineers and industry experts and the digital informatics space.

He is working closely with our core synergy and health system vertical.

Bidirectional integration interfaces to ensure we are well positioned to displace the standard of care and move the market towards a better solution for early detection of ovarian cancer.

In summary, we have invested in our growth strategy by constructing deployment model 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 <unk>.

St lunch in Q4.

Pacifically regarding sales, we started to Europe with 15 sales representatives in our core vertical and we now have 35 sales representatives across three sales vertical within these vertical the majority of the representative.

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 Doctor Alina 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 breast detection.

Berrien cancer specifically.

Thank you Kylie as a physician 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 our awareness and education. We have hosted multiple successful highly attended educational series and are currently launching Zhu I am enjoying oncology Advisory board directed at better management of pelvic masses, and a proven ovarian cancer early deter.

Sure.

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 a physician initiated research program for health care systems.

This program provides nominal funding for projects that helped 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 the significant paper, which was accepted and published as of August 10th.

It is an evaluation of the performance of over one and a cohort of patients with normal serum C. You want to refi values that was accepted to the special ovarian cancer addition of diagnostics.

Device title salvaging detection of early stage ovarian malignancies. When she was only five is not informative.

In this publication, we analyzed 2300 patient data from previous collections with a prevalence of four 5%, whereas he went to five levels who are in the normal range, depending on the age of the patients which is less than 67 units familiar for premenopausal women and less than 35 units.

Miletus proposed to Nepal for women.

Of most importance with demonstrated that in those women over one detecting detected over 50% of ovarian malignancies in premenopausal women that see what 25 would have missed.

Over one also correctly identified 62% of early stage cancers missed by C 125.

Cause the Standalone test. So you went to a five Mrs more than 50% of ovarian malignancies that can be detected by over one in both early stage cancers, and premenopausal women, which have a much better long term survival if detected early.

He is a clinician who constantly loses women's ovarian cancer is diagnosed with advanced stage, finding and treating 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.

Thank you Doctor 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 focus on clinical validity and utility of our current product over one plus more.

More specifically, we have two recently accepted publications, one which doctor Ratner just discussed and the second which is an update on our over one 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.

The risk assessment for women within the next one that it.

It is expected to be published at a future date.

This paper highlights an orthogonal laboratory reflects called over one plus that benefits patients who are not readily stratified as lower high risk using over one alone and classified as intermediate.

D O Vera is employed in these cases and it allows for a higher specificity.

This study was validated over a thousand prospectively collected retrospectively analyzed here on sample dataset and a prevalence of 22% and further verified using an independent dataset of 207 with a prevalence of 40%.

35% of the samples were defined as intermediate risk by over one test and reflex to ovarian which eliminated 58% of the false positives and improve the overall specificity to 72%.

Oh, very reflex testing of samples, which have an over one 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.

So let me reiterate my optimism for Endo check 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 endometriosis is an irreversible debilitating disease.

We are also excited to boost their specimen bank of endometriosis cases as diagnosed by laparoscopic surgical assessment with the collaboration agreement, we just announced with <unk> see that as it will assist in our future refinement of the endo check product.

I would now like to provide updates on oversight.

We continue to be on track for our accelerated launch of oversight. This fall the analytical and initial clinical validation of oversight performance metrics was presented at an ASP of poster presentation on June 4th of this year.

Accepted abstract presented data demonstrating the initial clinical and analytical validity of the virus oversight blood based biomarker tests for ovarian malignancy risk assessment and all women within the Knoxville math.

Samples collected from real World evidence studies with a low prevalence of cancer, 3.8%.

We're 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 and 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 2020 one.

I would like to now give an update on Ova inherit.

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.

Crease their study cohort to support the Ova inherit pesticide.

Our proof of concept study with Dana Farber Cancer Institute and 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 oversight with the high specificity by detecting micro Rnas here.

A multi omics approach that can help eradicate late stage ovarian cancer detection.

Multi omics technology will allow us the opportunity to develop the diagnostic 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 and innovation. These past two quarters is to enhance our clinical studies and enrollment despite COVID-19 restriction.

We are continuing to recruit larger academic institutions in clinical practices to allow us to collect from our 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 where we're building a lifetime relationship with the patient.

This is our over 360 approach and providing a circular loop of products to better women's health.

We are developing products that can start as early as men seized with endo check allow early detection risk of hereditary cancer with genetic hereditary cancer testing monitoring of high risk women with over and hear it and until later in life in a population of background risk of one 3% for ovarian cancer with no heritable detection.

Overwhelm Classman oversight.

And we look into the future and developing residual risk assessments as well as a reoccurring monitoring and eventually therapeutic clinical diagnostic testing innovation as the core of our strategy. Our goal is to invest and accelerate our evidence development and pipeline and surround it was wrong I P. As we maximize.

Shareholder value I will now turn it over to Bob for an update on our financials.

Thank you Dr North of where.

We reported second quarter revenue of 1.72 million, an increase of 136% over prior year and 21% sequentially.

6% product revenue increase was primarily due to a lower number of tests performed in 2020 due to COVID-19, as well as an increase in.

Average revenue per test in 'twenty, 'twenty, one compared to the prior year.

The revenue per every one plus transport increased to approximately $377 compared to 375 for the first quarter. The year on your price increase was 28% compared to the prior year second quarter of $295. This increase was primarily driven by an increase in payments right.

Interact with payers and improved collections, while we've made progress with payers in the second quarter. We took a conservative approach to revenue recognition and did not recognize revenue until we establish a track record of payments received.

Gross profit margin of Rogue, one plus was 52% in the second quarter compared to 54% in the first quarter of 'twenty 'twenty. One 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 over one plus increase from 37% to 52% compared to the second quarter of 2020, as we leverage our fixed cost with the increased volume.

Research and development expenses for the three months ended June 30 of 2021.1.47 million, an increase of 599000 or <unk> 69 per cent compared to the first quarter of 2021.

This increase was primarily due to clinical utility and product development costs related to oversight, our third generation product as well as investments in bioinformatics spiral synergy and consulting expenses associated with Endo check regulatory clearance in the second quarter spend represents.

Approximately $1 million compared to the second quarter 2020 spring or as we've made investments in personnel focused primarily in oversight and endo check.

Sales and marketing expenses were $4 million for the three months ended June 30th 2021 an increase of approximately 900000 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.

Ravi was 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're making in market awareness and the sales team additions general administrative expenses were $3.3 million for the three months ended June 30th 2021.

<unk>, an increase of approximately 793000 or 32% compared to the first quarter 'twenty 'twenty. One the increase was primarily due to an increase in head count and personnel expenses as well as stock compensation expense, we incurred $1.9 million in general and administrative expenses in the prior year quarter.

We entered the second quarter with approximately 53 million in cash cash use 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 endo check.

I'll now turn the call back over to Valerie.

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 Ova inherit 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 in 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 of one 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 oversight technology for benign mass management in Q4, 2021.

For the longer term, we are moving forward with our planned launch of Endo check for endometriosis, and lastly, ova inherit for high risk genetic predisposition monitoring.

Our end in mind as 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 a 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're now happy to open up the call for Q&A and answer any of your questions operator.

At this time, we'll be conducting a question and answer session.

I'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Press Star two if you would like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please while we poll for questions.

Okay.

And our first question is from Brian Weinstein with William Blair.

Please proceed with your question.

Hey, guys. Good afternoon, Hey, Brian a question or my pleasure.

We have a lot going on and so trying to come up with a couple of questions that are.

Kind of our targeted but.

On the oversight yeah, obviously, the Q4 launches great can you talk a little bit about how you're preparing the organization for that I 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 oversight.

Should we be thinking about.

Our price point here.

Here I think you had made some comments about their previously but just wanted to kind of confirm kind of the price point, there and your plans for payer outreach on that front on that product.

Sure. Thank you for the question. So I'll start and then I'm like highly chime in so it was always say because the market size for oversight is three times that of Oba.

So we are launching oversight in all of our verticals in terms of did you I am as well as the hospital market in the future it'll also be a synergy product as well.

Our go to market with this and we're also you know I want to caveat with this COVID-19 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 he is a virtual approach as well. So it's a twofold approach, but what we're really pleased about the progress we have.

<unk> brought in some I wanted to say outside consultants from a creative standpoint to really help us launch this.

From a continuing medical education to ensure the reps have had 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 are they wanting to use ova, but I'm gonna have Kylie go into details in terms of the physical launch.

And how we are readying the sales team.

Hi, Bryan. Thank you for the question. So I'll go into a little bit of the commercial design of what we've constructed in preparation for the whole bank side.

March we had as we mentioned we increased our commercial organization and the sales book, specifically by 75% since January and this is really to address the fact that oversight 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 the 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 I'm.

Actually we have we are really focused on putting salespeople, where it matches. The ICD 10 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 a 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 I'm very targeted campaigns and approaches whether it's through web or social or web search and Google too.

To ensure that we've got proper education that we're effectively priming the market before lunch.

Hope that answers your question, but I'm happy to take any further.

No. That's all that's great and then.

Just on the on the payer outreach out there for OSA how how.

Our players how are you going to be working with payers here to to to generate adoption.

Sure. So over one is really grease, the skids with pairs are Brian. So as we just received the <unk> guidelines it opens up the door for Overwatch.

Overwatch or oversight them you know in a big way. So we're starting with the PMA code. We are we've 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 paths that we can get reimbursement as quickly as possible. So.

I think all of us really grease, the skids were already priming, the pump and getting B I would say renegotiations on the contracts, where we have contracts the inclusion of oversight into those contracts and as we brought on board a Greg Richard from the managed markets perspective, we are adding resources because between the aim.

And now over say, we really have quite a bit of work on the managed care side.

Yeah.

Great. Thanks, and then on the synergy side, you know I'm I'm, just curious kind of what constitutes a large account I mean, how do you guys bifurcate that market figure out you know, what's what's an appropriate synergy accounting can you remind us when the economics are for.

Are you guys there versus having these tests rather than your own lab and then I guess, that's it on the synergy stuff and then I'll have one more after that.

Sure. So let me start in terms of the size of the account in terms of customer segmentation, where we really are looking at is 100, plus physicians being a very large health network and and these health networks is not just G land focus Theres. Some health work pet health networks that are actually primary care.

Angie land.

So we are looking at 100, plus physician health networks.

We've closed one which we are actively implementing right now and we have a 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 genetic side.

There is also interest Eddie laboratory level. So theres laboratories that are sending out there H B O C testing to let's just say a you know a common H b O C 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.

<unk> for us is really depending on Ova oral genetics. It is going to be at very high margins. So the total price of course is lower than I was doing the ova ourselves, but in terms of margins. It has high contribution and I think more importantly is going to be the fact that these especially on the with Q1 'twenty.

<unk> side as well as the genetic side. It is a revenue opportunity for the 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 it will truly be a.

Software as a service model.

Great and then last one for me is on Endo check. So can you just talk about the importance of the additional set of samples that you're getting or are they different in any way from the samples that you were getting from your first partner in terms of makeup.

The individual that is who.

Where the samples are coming from or is it just getting even more samples and get them.

What is the kind of importance of getting these additional samples where you're not getting enough kind of put their first partner or is there something broader here in terms of a potential longer term relationship that youre trying to signal.

Yeah really good question. So these samples are from a second partner of Veeva Aviva is trying to build a drug to compete of course with <unk> with better safety profile and these samples are actually a different specimen type.

Their plasma versus serum and this does allow us to expand things from an analyte perspective as well as it is it more of a global population.

We're very we're really really pleased about it and I would say also in terms of I believe of being a public company you will see that actually they have actually cancelled their trial in the U S. Because they were not able to to recruit patients into their trial, because the patients with endo or not having surge.

So they truly need a diagnostic to complement that so there is there is.

A high level of dialogue with with the with this company and having two separate banks from two different separate companies has truly been a game changing for us and a really helps just bolster overall endometriosis research.

Okay. Thanks for your answers are we'll get some more info on color. Thank you.

Good Brian.

Yeah.

And again.

If you have any questions you May press star one on your telephone keypad to join the queue. Our next question is from Charles Duncan from Cancer. Please proceed with your question.

Okay. Thanks, Valerie and team congratulations on a good quarter of progress and thanks for taking my question I had a couple questions.

Questions first on the commercial side for over one I guess you have very 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 in.

To the second half of the year, particularly with the Delta there and I think you mentioned increased access for for a physician access and I guess I'm wondering how you feel the dynamics of the of the Covid pandemic could impact growth going forward.

Sure well. Thank you Charles for the question. So let me start and I'm going to have Kylie actually jump in so we we came out of Q2, and the 4500 range and I'm really pleased and by the way the majority of our sales team members did not join to the back half of that so.

We were really pleased with the Q2 performance coming into Q1 with 15 and taking up to 35. So.

Going into Q3 are each one of these reps really is going to have their first quarter of.

Our performance. So we have a larger footprint number one number two our patient base are patients that are not being screened so there's a sense of urgency they have a math.

Whether it's benign theres 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 the screening products and.

And we saw this during COVID-19. So the nice part is is that during this process. We sort of are looking back at phase one of Covid and saying, Okay. 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 O arm when they're high risk and helping doctors manage patients that were low red.

Actually say to them look you are going to do so we're gonna do surgery, but we're gonna wait wait 30, 60.90 days so that same playbook.

Going forward, but I would also say another piece of this is just the virtual element of this we really have you know just everyone's keeps on track with the news although I saw some good data in the U K, where delta has surged and that actually decreased but I would say that we are we are preparing a plan a and a plan.

Where we're prepared with our larger footprint to not only get the access but also we have a very well integrated virtual program, but I'll have to probably go into in detail.

Okay, great. Thank you. Thank you Valerie so to reemphasize salaries point 20-F, 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 towards 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 man, but to Valerie point, we are thinking very strong about the delta Varian 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 for new channels and we expect to do this we've done some of this already but we expect to continue and formalized in the next few weeks. One we have rigorously focused on the digital marketing strategy are we.

That is a segmented approach around lots of different markets and have heavily invested in ensuring that we are educating through every digital channel that we count them, we've seen incredible uptake and that's to the tune of double the amount of volume to the website then close to those numbers on our social media number two are we have put together a virtual card.

One two okay. Our marketing team is hard at work constructing that this is a toolkit that has six pillars that will allow our fourth to continue with their strategic plan virtually and effectively if necessary number three we've invested very strongly in our physician to physician platform. So before or we've had a modest number of physician.

On stack, we've rapidly increase 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 bifurcate 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.

Seen a lot of success in this peer to peer discussions number four we are actively involved in executive leadership level.

Level within the company are looking at strategic partnerships with other organizations and this isn't a typical approach in that we're not looking at typical business to business relationships that would further research and development et cetera. 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 cars 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 up modestly to virtual.

They're very highly hope that yes, I hope that gives you enough granularity.

Yeah definitely provides a lot of good information I guess just to follow up it sounds like a full fully inc. Increased size sales force for full productivity in the income.

Call it the fourth quarter and then beyond.

Do you focus on a new new prescribers are new users more so than with prescribers.

Practice or or how how would you define success going forward, because I think Kelly mentioned, 14% increase sequentially in terms of prescribers.

And I guess, what would you like to see that.

Yeah.

Thank you so much for the question. So it's actually a great question and 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 that 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 cannot and stickiness within.

<unk> 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 in translating our what now is a customer service division into more of an experience and doing some work to retain and increase our footprint within the physician practices that we.

<unk> 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 them wherever attention problems might exist how to rapidly fix those address them bring them back into the fold and continue to move down this road with that.

I expect to see the new physician percentage continue to increase that that continues to be a big focus.

Simultaneously you will see our inside sales force and our customer experience team worked to increase our customer retention create a wonderful customer experience and create stickiness with them are important customers.

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 you know it's usually the the the friendly or the first physician that starts but then its going through that whole practice extremely important too.

As we close these large practices that are 100, plus physicians. So it's getting that 80.20 from those practices and that's that's a different cell processes, you know, but it's that continuity and that maintenance is also very important and it's clearly pointed out with the inside sales force I wont say, we have some service threats.

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 their retention within that customer.

Do you feel like you're in at a sufficient capacity now or would you anticipate in the next call. It 12 to 18 months some additional hires in the sales force.

I think you know with Endo check them you know that market is 20 times. The Ova, that's going to take us to a a whole another hemisphere. So right now we're at about 35. It will probably go up to about 40 hold tight through oversight because he's really prep for oversight. So we can we can really get that market.

Being adopted but with endo check them, 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.

Can I ask you one last question since you brought up that you'll check.

I know, you're not kind of be able to be all that disclose of a.

Given discussions with the agency, but you mentioned sensitivity and specificity and you know please that you will exceed that of endoscopy surgical assessment, but I guess, you know beyond just talking about certain numbers.

I'm wondering how you would see a clinically meaningful improvement and it seems like your endo check is much more convenient or or fast sell then 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.

This one is really difficult, but with regard to the timing of those FDA discussions can you provide any color.

Sure. So let me just walk you through this is like this is a it's not a complicated answer but this is a multi fronts endo check will make a difference.

If you look at the pain I'm, just going to walk through pain delay in treatment and the major just the care pathway to start with pain, what endo check will provide immediate disease detection right. So a patient may try O C teaser and dads, you know nutrient et cetera, but it'll it'll basically supply immediate detect.

And 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 error medical management.

Second is right now and endometriosis take seven to nine years based on the latest data and so what we will do is eliminate that delayed diagnosis really halt disease progression. If the therapy is put in place it improves the quality of life by reducing time to treatment.

The other pieces exploratory surgical intervention, we can avoid surgery, that's unnecessary right only perform it if it's clinically warranted and I would say the last piece is really when the the gnrh antagonist is actually therapeutically administered this will prevent the delay.

Of course in treatment plant the delay of major disease progression and again I think in summary, the 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.

So say with the FDA, we're going up against mostly I'd say oncology changes so mycology diagnostics in oncology breakthrough. What we are doing here is is really novel and that we are taking a benign 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 it was experts on all different facets, but having a 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 there's and it's breakthrough because theyre, giving you advice as you're building your I want to say your protocol.

And in and recognizing that there's this is unchartered territory and Theres 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 you know we've gotten a lot of great feedback.

I do believe that there is there is there is a partnership here so things are going well.

Okay. Thanks for taking my questions.

Our pleasure Charlie.

Okay.

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.

Thank you operator.

In closing, we believe that our accomplishments during Q2.

It's 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 of tests 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 the <unk>.

To support continued growth and profitability.

Our end goal.

Cause concern a large global pelvic 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 wellbeing to each and every patient we serve.

Thank you for joining us today and we appreciate your support and interest in a spiral women's health.

Okay.

This concludes today's conference and you may disconnect your lines at this time.

Thank you for your participation.

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Yes.

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