Q4 2020 Aspira Women's Health Inc Earnings Call
[music].
Good afternoon, ladies and gentlemen, and welcome to our sphere of women's health fourth quarter, 2020 Conference call. My name is Laura 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 is being recorded leading the call today are Valerie Palmieri, President and Chief Executive Officer, Bob Beachy, Chief Financial Officer and <unk>.
And I leave Dogger, Chief operating officer, Dr. Leslie North book, Chief Scientific Officer, and Doctor Alina, Ratner Global Chief Medical advisor and 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 a spheres and 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.
Fuel 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 our spear. The company assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise.
Weapons are directed to the cautionary note that fourth and today's press release as well as the risk factors set forth and our fears annual report and third quarter 10-Q filed with U S E C.
For factors that could cause actual results to differ.
Materially from those anticipated and the forward looking statements at this time I would like to turn the call over to Valerie Palmieri, President and Chief Executive Officer Valerie. Thank you you may begin.
Thank you operator, good afternoon, everyone and thank you for joining US today. This afternoon, we will review, our fourth quarter and full year, 2020 accomplishment, our financial performance as well and update on our Q1 developments in terms of and acceleration of a product launch a strategic agreement and payer.
Average and addition, I will be introducing two of our newest members of our executive team.
That's our later Ratner global Chief Medical advisor of clinical and translational medicine, and Kylie Zag or our chief operating officer.
In addition to our executive team additions. We also recently appointed two new board members as well that's a standard Brooks M D and Nicole Sanford Gotcha.
And that's your breath is the senior Vice President and Chief Medical Officer of Thomas Jefferson University hospitals, and it's regarding your field as a thought leader and health equity.
MS. Sanford C. P. A is currently the executive Vice President and Global Board services leader at the early group and prior to this role she was a national managing partner for Deloitte regulatory and operational risk practice.
Both appointees bring tremendous expertise to our board to help us take our company to the next level.
I would also like to note that the majority of our board is now comprised of female directors at 71%, which we feel is important as a women's health company.
I would now like to update you on five recent developments and the first quarter before I move into the 2020 review.
Today, we are announcing the acceleration of the target launch date of oversight to the fourth quarter of 2021.
This technology was originally planned to launch and the first half of 2020 two.
But based on the unmet market need, especially during the pandemic. We have made some additional investments and advancements in our algorithm. So we were able to launch ahead of schedule. This test which was previously named open next will allow physicians to monitor a pelvic mass and patients who are not planned for surgery.
This is specifically designed for a population with a low prevailing a disease and has a total available market, which is three times that of over one plus a $1 2 million patients per year.
Second I am very happy to announce we have entered into a significant strategic research collaboration agreement for the development and commercialization of and ovarian cancer detection test for high risk women. The collaboration with Dana Farber Cancer Institute, Brigham and Women's Hospital, and the medical University of what they have.
Collectively published a novel Microrna and micro RNA panel, which we intend to use in combination with our current technology.
We believe the highest specificity demonstrated by this technology, coupled with our strong sensitivity has the potential to be the base technology for a diagnostic which will function as a early stage high risk screening test.
Doctor and Northrop will cover more details in her section.
Number three we announced coverage by New York State Medicaid one of the largest Medicaid populations in the U S. Covering 29 per cent of the population and the state. This is six and there's significant add to serve the underserved population in New York and this brings our total covered lives to 179 million or <unk> 54 per cent of the U S population.
And as of April one 2021.
Number four last month, we completed a public offering for $45 million, which was oversubscribed and has significantly strengthened our financial position and finally in March we presented at the congressional briefing titled advancing health outcomes for women and minorities, we deliberately.
The action for over one as a standard of care for ovarian cancer risk assessment for Caucasian and non Caucasian women and the need to fund large race and ethnicity based trials.
I am now moving onto a recap of our 2020 performance.
Last year was unlike anything we could have ever imagined, but I am so proud of our employees and how we effectively whether the pandemic storm.
We delivered solid test volume growth improved price added to our covered lives and lastly made significant key additions to our board medical and executive team.
We also continued to advance our product pipeline and strengthen our financial position as well during 2020.
Highlights of 2020 included seven major milestones number one and adding to our payer network with the addition of the Cigna contract agreement. This is our first national payer and we received very favorable rates.
This and network agreement added an additional 16 million lives to our contracted plans and includes over one and addition to our ovarian and cancer genetic testing panels known as the spiral genetics.
And number two added we added to our Medicaid coverage with 13, New state plans major states added last year, where Georgia, and New Jersey, and South Carolina with the addition of New York, Our total credential and Medicaid population now stands at 60 million lives, which is 78 per cent of the U S. Medicaid population.
Having this coverage and play it is so critical to managing the underserved population as we believe over one is the only technology available today that has adequate sensitivity for ovarian cancer detection and specifically black women.
Number three through our digital and media campaign, we continue to increase the awareness of our technology and its superior performance relative to C and 125, and both early detection of ovarian cancer and the detection of ovarian cancer risk and the black population our campaign had a total of 133.
Media placements with a total of 139 million total media impressions.
Number four we entered into a specimen collaboration agreement with Abbvie and the agreed to provide us the arms specimens and data and clinical metrics from the illegal ex trial. These samples will support the development of Endo check and the first quarter of 2021, we also submitted an application to the FDA for a breakthrough device.
Nation and expect to have a dialogue with D E and the second quarter of 2021.
Five as a patient centric organization, we formed our own internal patient Advisory Board led by Chief spokeswoman. Dr. Diane pilot. This board includes ovarian cancer patients and survivors, whose mission is to lead how we serve and educate patients.
Number six we also successfully rebranded the company from Vermillion to aspire and women's health. The successful rebranding centered on our commitment to focus on women's health. In addition, we rebranded two products over next to oversight and aspire and genetics technology transfer to a spiral synergy as well and finally.
And we executed this year doing and extra ordinary and unprecedented times.
Before I turn the call over to Kiley, who will cover Spyros commercial momentum in detail I want to summarize the impact of our investment and commercialization and the progress we had.
Our fourth quarter volume grew sequentially over third quarter by 7%.
<unk> revenue was up 15% due to volume growth as well as and 8% price expansion on a per unit basis, Bob will cover that in detail.
In summary, we continue to work towards our overall strategic goal, which was two and emerge stronger from the pandemic and we believe we have accomplished this with a stronger team our stronger financial position and a stronger pipeline.
We are well positioned to invest to grow and to drive adoption and most importantly save lives.
Yeah.
It is now my pleasure to turn the call over to Kylie zag, or a seasoned healthcare transformation executive whose experience spans across multiple health care industry disciplines.
She brings extraordinary talent and abilities and building white space business verticals disrupting standard of care with net new technologies and elevating senior leadership teams to optimize performance.
And a short period of time Kelly has launched a commercial strategy that is preparing us to significantly scale, our commercial operations from standard of care adoption.
We are thrilled to welcome her to the executive ranks of aspire and women's health.
I'd like to introduce Kylie.
Thank you Valerie I'm unequivocally excited to be a part of this leadership team and this company, which represents a very important and personal message to me early detection of gynecological disease, beginning with ovarian cancer undoubtedly we have a robust pipeline of products and are positioned to disrupt the standard.
Care and the health care community and will subsequently and exponentially.
The lives of women by intercepting these diseases prior to late stage diagnosis.
At the commencement of my tenure deep analysis was performed with the intention of understanding the patient lifecycle of our products and overall value they bring to the patient and order to maximize and optimize our commercial position, we have enhanced our strategic plan and the following ways number one the repositioning and investment and of course.
Sales to capture 100 per cent coverage of North America, and strategically focus on significant practitioners that can and will impact the standard of care conversion.
We are markedly focus on a race and they'll disparity within the core sales team and with our increase in Medicaid coverage. We are diligently focused on accelerating access to care for these patients we will be increasing our sales team investment by 38% and Q2 to prepare for continued growth as well as the Q4 oversight want.
Number two we have launched a health systems team that will integrate our technology and the clinical pathways across various ology that intersect and ovarian cancer patients and integrate into the complex workflow environments of the system.
With over 80 per cent that physician scheduled to be owned by health systems by 2020. Three we are confident that this strategy is critical and timely for our organization.
Number three we have sat and motion and integration team comprised of highly experienced clinicians with informatics expertise. This team will work and a matrix drive informatics integrations within the health system and create seamless workflows for adoption of our products.
Number four we are creating a world class customer experience for all customers book small and large we are expanding the size of this organization with the intention of providing optimal communications white glove service and create an impeccable experienced for health system providers and patients alike.
We believe it will be a strong differentiator and contributor to the top line growth.
Number five.
We have redeployed our synergy sales force to drive rapid adoption and penetration of our cutting edge technology transfer platform. This is our decentralized platform, which is focused on health care system does this and labs and clinics synergy will also expand access for all fireeye commercialized products and future.
Her pipeline innovate innovation will be blended into the synergy platform.
All commercial verticals or horizontals like connected with sharp focus on penetration ease of use of our products and rapid acceleration of our growth across the continuum of care. We are now poised for growth to allow standard of care adoption of book over one class and genetics as a solution offering.
And finally, the glue to our strategy and.
And the commercial activation of the market and awareness to the greater population. They are critical cornerstones and will be the fuel for growth behind the sales organization. We have built our marketing organization and the past 90 days and have amplified the focus around driving strong call to action campaigns across multiple channels.
The center of this strategy, we have placed the patient advisory Board led by Dr. Diane Palace Archie spokeswoman. This board is working to bring the patient experience and journey to life, while simultaneously magnify the horrific nature of ovarian cancer across the health continuum and with key constituent and such as the F. D. A.
And then insurance community.
Now I would like to pivot and Q4 performance and offer and insight into how the teams are performing and Q1 as Valerie mentioned, we delivered 7% sequential volume growth and the fourth quarter and the context of continued COVID-19 restriction ease restrictions continued and the first quarter and our sales territories.
In February we also experienced and patient and delivery disruptions due to inclement weather.
And we are seeing a pick up in volume and Mark as the transformation strategies are gaining traction and the impact of the pandemic. Christy. We believe Q1 will track very similar to Q4 in terms of volume due to these compounding factors and expect momentum to begin to build at a strong pace in terms of ordering physicians for the quarter 2000 and.
605 physicians ordered over one plus with 82 per cent of the providers being repeat providers consistent with our prior run rate. It's clearly illustrates the impact of technology has on patient care and stickiness of the technology and the overall retention and growth opportunity, we have with our expanded portfolio and <unk>.
And of ordering physicians increased 6% from the third quarter and flat year over year signaling and we are back to pre COVID-19 levels and Q4, I would now like to hand, the call over to Dr and Northrop to provide and update on our innovation pipeline.
Thank you Kylie.
Good afternoon, everyone I would like to provide a brief update on our upcoming products and enhancements as previously discussed with over 10 years of expertise and ovarian cancer risk assessment, we are creating a portfolio, which is comprised of products the impact of women's entire lifecycle, starting with young adults with endo check.
Two our hereditary risk for cancer cannot ex including high risk diagnostic screening ova inherit to benign mass monitoring oversight and lastly, our ovarian cancer risk assessment prior to surgery over one plus we are continuing to increase our investment and R&D and.
And one of our key investments is our efforts on closing the disparity gap and women's health care specific to the diagnostic accuracy of ovarian cancer detection, we have five active sites and world and our disparity clinical study. The most recent addition was Wayne State University, and Detroit, Michigan, and our first national.
Cancer Institute site.
Our timeline for completing the study is still on track for the end of this year. The goal is to publish the manuscript by the first half of 2020 two.
In parallel we are continuing to recruit additional ethnic populations such as Hispanic black Asians into our oversight clinical studies as well as our international over one and ovarian study sites and the Philippines and Israel.
Both of these studies sites are ending soon and we are actively working on the data from multiple publication efforts. It is imperative, we continue to capture and enrich population of women and so that all of our current products and future products, our pan ethnic focused.
Our second key investment is on our third generation ovarian cancer risk assessment test, which is now branded as oversight. We are pleased to announce today that we are now accelerating the launch date to the fourth quarter of this year with full national availability in 2020 two.
This was driven by our belief and the clinical need to offer a risk assessment testing for all women, who present with a suspected pelvic mass.
During the pandemic it became clear that assessment of masses, not requiring surgery is a critical need. This pass allows physicians to clearly classified masses as low or high risk from malignancy to help guide clinical management.
We submitted an abstract to the American society for clinical oncology for their early June conference of this year and we'll be publishing both the analytical and clinical validation findings in Q3 of 2021.
We have received well over 500 prospectively collected specimens from our clinical studies that will provide real world evidence data on the performance of the test.
This is an exciting time for the innovation team and this will be our third product launched under my leadership, our CSO first being the genetics platform and second being the spire synergy genetics.
I will now review, our aid and diagnosis of endometriosis test known as Endo check.
We believe there is market demand for our non surgical blood based test to confirm the cause of the chronic pelvic pain of endometriosis early and help guide clinical management.
Currently endometriosis is treated based on symptoms and is diagnosed by surgical visualization and or biopsy.
And do check will address the patient population of women, who are experiencing chronic pelvic pain and want to forego surgery by providing reassurance that their symptoms are indicative of endometriosis.
The goal of this test is to allow for early diagnosis to direct appropriate clinical management that potentially reduces the progression of this disease.
The early validation of an intended use population from illegal ex trial was submitted as part of the breakthrough device designation and January and we are and dialogue with the F. D. A.
In addition, we receive access to another valuable specimen bank from a consortium of six academic centers entitled and Doe marker study. This study was funded by and I C. H D and support of the reproductive Medicine network and endometriosis and research.
These specimens will support additional validation efforts of Endo check.
Additionally, we are in and early proof of concept of our Ova inherent tests of diagnostic tests and specific to high risk population of women predisposed to ovarian cancer, either due to family history personal history or genetic inheritance.
As mentioned earlier by Valerie we are evaluating Dana Farber cancer Institute bring them and women's hospital and the medical University of lots and micro RNA technology with diagnostics specificity in conjunction with our oversight proteomics panel, which has high sensitivity as it potential diagnostic measurement of ovarian cancer.
Answer.
Currently clinicians can order CA 125 was suboptimal and sensitivity and specificity in conjunction with ultrasound to assess risk and this patient population we.
We feel the combination of proteins and transcriptome ex well outperform the current standard of care and provide better early detection of ovarian cancer.
We are very excited about the innovation product pipeline.
With these products and we are circling the ovarian cancer disease state and a 360 degree view and.
Ensuring that we understand the patient's hereditary rest for gynecologic cancers, with our genetics product to help prevent disease evaluating the cute risk for cancer and women with massive planned for surgery with over one plus.
And those were a monitoring strategy, maybe more appropriate with oversight and moving towards a diagnostic test for women at high risk with Ova inherent.
But our greater goal as a company and to improve women's overall health to do so we must address other gynecologic disease states like endometriosis that effect up to one and 10 women worldwide.
This is the core goal of and know Jack and then eight and diagnosis of endometriosis.
We believe endo check will provide a life changing disease modification by enabling early diagnosis and treatment for women's starting as early as young adults.
I would like to now turn the call back to Valerie Valerie.
Thank you Leslie before we have Bob provide and update on our financials I would like to introduce Dr. Elena Ratner Gotcha Ratner recently joined our team as global Chief Medical advisor of clinical and translational medicine. She is currently the clinical division chief of Gynecologic oncology at Yale University School of Medicine.
And she also serves as a director of the ovarian cancer early detection program that is part of the discovery to cure Yale Medicines initiative focused on combating women's reproductive cancers.
This initiative resonates greatly with aspire is mission and vision Doctor Ratner.
Thank you Valerie I'm delighted to join the call. This afternoon.
First mission is to provide women with truly personalised ovarian cancer risk assessment and to enable early ovarian cancer detection for women and a bowl aegis ethnicities and races, which is the core of my research and clinical practice and the stride from improving survival ovarian cancer patients and changing the narrative.
Yes.
Two day survival would be and cancer patients remains dismal and unacceptable.
This is due in great part due to the challenges early cancer detection as well as considerable racial health and growth.
Peace and management of the disease.
Women of color, especially African American women continue to have significantly lower five year survival rates and Caucasian women.
The manufacturers, which drive that but.
But having access to the best risks to the best risk assessment technology in order to improve early stage cancer detection is critical.
For generations, great amount of funds is being invested and a great deal of research is being done and the fields of surgery and chemotherapy and the disease.
And yet a great majority of ovarian cancer patients still die from this cancer.
This is due in great part to the delay and early stage diagnosis, and making it clear and urgent the debates come for better and cancer early detection tests.
And the technology to serve women of all ages ethnicities and races for our best chance of changing the future of this disease.
Our end goal is to implement our technology as part of the care pathway and the institution level. So that all care providers and every patient has equal access to the best personalized risk assessment solutions.
I would like to turn the call back over to Bob for review of our financial results Bob.
Thank you Dr Radnor.
Good afternoon, everyone I'm delighted to be here and I welcome our new team members.
We've had continued volume growth from the fourth quarter and now I'd like to make some high level comments on the financials.
Revenue was $1 4 million for the three months ended December 31, 2020, compared to $1 2 million from the third quarter. The 17% sequential increase is primarily due to an increase and a one touch volume compared to the prior quarter and a sequential price improvement per over one plus.
Tests perform two three and $364 compared to 338 and the third quarter.
The number of day, one post test performed increased 7% to 3849 and a one plus test during the three months ended December 31, 2020, compared to 3596 over one plus tests performed from the third quarter volume increase was primarily due to our commercial.
And you shouldn't investment and a further increase and patient doctor visits as patients have adjusted to the Covid environment.
Profit margin on a one plus was 50% and the fourth quarter as compared to 45% and the third quarter driven by improved volume and improved price realization.
Research and development expenses for the three months ended December 31, 2020 were 735000 or 24% increase from the third quarter level of 594000.
This increase was primarily due to product Rome and cost related to oversight as well as investments in bioinformatics and aspire with synergy sales.
Sales and marketing expenses for the three months ended December 31, 2020 were $2 8 million compared to $2 2 million and the third quarter, a 32% increase this increase was primarily due to increased expenditures and marketing to improve awareness as well as slightly higher travel and entertainment.
And 19 pandemic restrictions slightly eased and investments and the commercial team.
General and administrative expenses for the three month period ended December 31.
2020 were $2 7 million compared to 2 million and the third quarter and 39% increase this increase was primarily due to an increase and legal expenditures as well as board of director fees as we settled the fourth quarter and storm and aboard restricted stock units and cash to defray.
Tax liabilities, which arose in connection with ours and <unk> grants earlier and the year.
Our total cash utilization and the fourth quarter was $4 2 million compared to $3 1 billion and the prior quarter. The fourth quarter included 428000 and related to the onetime cash settlement of restricted stock units. The remaining sequential increase from cash utilization was due to the increased investment and market.
And and.
Warehouse as well as the investment and commercial and R&D.
Ended the year with approximately $16 6 million and cash and February 2021, the company completed a secondary stock offering resulting in net proceeds of approximately $48 4 million after giving effect to underwriting discounts book before expenses, we believe the current strength of our balance sheet.
So as to properly fund book for commercial and innovation opportunities facing the company and then I'll turn it back to Valerie. Thank.
Thank you Bob before we open the call for Q&A, Let me restate our focus on building the company for sustainable growth for the near term and the long term.
And a year dominated by the pandemic, we delivered record enterprise value growth financial stability as well as we strengthen our team and our board I am proud of what we have achieved and optimistic for a strong 2021.
We firmly believe that our strategy is the right one and that our technology and pipeline will be vital to lowering the overall health care burden and reducing significant inefficiencies and that care pathway.
It's all about getting the right patient to the right Doctor and finding the cancer at its earliest stage and all women. This mission is the core of our company.
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.
And our work and products are at the forefront of changing the standards of care and the detection of ovarian malignancies. We believe we are helping close the gap and detection and more importantly survival for women.
Yeah.
And the near term, we believe oval and plus coupled with our disparity differentiation and genetics testing will become the standard of care and pelvic mass risk assessment for ovarian cancer for.
For the longer term, we are moving ahead with our planned launches of oversight and go check and lastly, Ova inherit.
We also believe and this new Covid era that racial and ethnic disparities and the importance of diagnostic information might actually be further elevated to reduce disparate care and ensure that all women of every socioeconomic background and you see the best care possible. We are now happy to open the call for Q&A and answer any of your.
Questions operator.
At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad and confirmation tone will indicate your line is and the question queue. You May Press Star two true and most of your question from the queue for participants using speaker equipment and they.
Be necessary for you to pick up your handset before pressing the star keys, one moment, while we poll for questions.
Our first question comes from the line of Brian Weinstein with William Blair. You May proceed with your question.
Hi, Good afternoon, and this is Andrew on the day. Thanks for taking the question maybe to start on the partnership announced today are Valerie could you maybe just talk about sort of your level of confidence and bring it from products like this.
This technology and I guess related to that.
Sure.
And so on.
Okay.
Okay.
Yeah.
Hi, Andrew and good afternoon. Thank you for joining.
Your line was going in and out a little bit. So I don't put your line or our line I'm, hoping and what was your line. So are two a couple of things Theres been two papers published and this is a partnership that we started a couple of years ago in terms of evaluating their technology and and as you can hear from the earnings script that is focused on micro.
RNA panels. So it's a collection of a panel Harvard as well as Dana Farber and break them and the University of luck had spent a number of years really studying the high risk population. So this is technology looking at a specific panel for those high risk patients and as I said, they published two papers with Signet.
And he can't P. P V and we haven't stated the P. P D and public domain, but we can send you the papers and it's a very significant P. P V and very high specificity. The study that was initially done was about four and it from 454 patients and of that study about 34 per cent of it was early stage.
Great. Thanks for that and then maybe just following up here and recognizing it's still pretty early and that development work could you just maybe provide some context around sort of levels of test performance that you think are needed for a commercially viable product and that's really sort of what level of book sensitivity and specificity at that early stage should we be thinking about.
And for brought uptick here.
So I would say that two things is that you know the colorectal screening guidelines just came out right and honestly I thought that the the performance metrics from the lower side, we are aiming some something and that 90 595 range ideally we'd like to get our specificity up to that you know, 99%, but I wanted to say 90 590.
Five is kind of what we are aiming for.
Perfect and then Bob just one for you didn't forget about you here one with a number of initiatives ongoing how should we be thinking about the opex and cash burn for 'twenty, and 'twenty, one and and pacing of that throughout the year. Thanks for taking the question.
Charlie referenced the fact that we're expanding on I think Q2 was the area, where we're going to have a little bit of.
Boston investment and that's not offset by the revenue that's not going to be dramatic. If you will I think when we phase those new hires out, but it's really this hospital group that we view.
As the driver to drive standard of care and.
And.
And it's phased over Q1 and that and that team will be in.
And the high single digits.
We're also looking at some investment.
And the investment as well as well as the spending on the R&D. So I think you know.
I think and those terms that will be phased in over time and as the hospital group starts to turn revenue in the third quarter.
Lot of those investments will start to pay for themselves. So I think it's really a relatively short term bubble and fairly modest I mean.
Our objective is to this recent raise we did.
We want to be very measured in terms of.
And having that bridge us to cash flow positive that it was our stated intention when we did the deal and we're staying with that.
Great. Thanks, everyone.
Thank you Andrea.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Our next question comes from the line of Kyle Nicks and with Cantor Fitzgerald. You May proceed with your question.
Hi, guys. Thanks for taking my questions Congrats on a.
Great Okay.
So I wanted to start on the Ob slight acceleration.
And I guess, it will be training and the sales force be any different for almost like Perceval, and plus and I guess genetics and just talk about that and then I really just wanted help from I would love. It. If you could help me understand how to think about the market five here. So I can get it and monitoring tests. So that would be a few times a year I think two to four times, what you said in the past.
But in terms of in.
In terms of price things like ASB, how much lower than the typical like 330 could that could that would be ultimately and I'll leave it there.
And so off of the.
They call them.
No problem, so kind of I'm going to start and then I'll, let kylie fill in as well and so in terms of training and the sales force. It's the same call point and so number one same call point and we've been selling a product in terms of a risk assessment, where a woman a doctor's dresses and womens and to understand which doctor to do the surgery.
And what doctors are really looking for is they really want attached for those patients that actually do not go to surgery and we saw that during the conservative management through Covid and we actually are seeing that with a paper that we recently published in October where we had a large percentage of our lowest patients who did not move forward surgery.
Keep in mind Premenopausal women had the largest number of pelvic masses and a lot of them and a fertile. So surgery is is something that is top of mind. So that's number one number two in terms of E. S. P and the E. S. P. Initially that we will be rolling out more of a stacked code version initially.
But we will be going for and a M. A code just like we did with Oba. So it will be crosswalk to a similar oba I do think that there'll be some pricing and discounts on that because it's going to be a test that we envision will be two to four times per year keep in mind. The product that we are initially rolling out will be eight initial.
That is not for serial monitoring I just want to make that clear. So we had three cohorts on the oversight trial. The first the first cohort is a and assessment of the the risk of malignancy for benign masses. Those the patients are not planned for surgery. So it's a onetime use and the doctor elects to use it more than once.
They can do so but our next revision of this will be a serial monitoring use of the product so going back to the T. M. I would say that the team that we had is 1.2 to 1.5 point and one 5 million women in terms of the use of the product that will be rolling out initially that will be again subjective to the.
To the Doctor and then we will be rolling out the two to four times per patient per year. So just kind of he wants to comment on the training that she's going to be putting in place for this new product.
Hi, Thank you so much yes, we we have a robust go to market and placed right now over the next six months, we'll be constructing not only the marketing strategy, but the field training strategy and we will be actively getting the field team involved and that's as of June. So we have a three month lead time of getting everyone integrated getting up to speed on the products under.
Setting the new market segmentation that we are approaching and how to do that so that we can rapidly penetrate and drive towards standard of care adoption as quickly as possible.
Does that answer your question Kyle.
Do you have allergies and Pablo Thanks, a lot for answering my that's great and just a good idea on the sales force and a little bit further actually so I guess currently could you just kind of talk about like where you start from kind of standard and then when you increased 38% and I think I heard and the second quarter that would be like 27 and 28 reps.
But like you know those.
Let's take the typical six months to train and then where will I guess, the wherever you may be prioritize convertible beyond COVID-19.
Youre rolling out the new product and so and synergy and there's a lot of different things to kind of think about it if you're a rep.
Buy it for you you're only simplify your play and so what we have is we have a.
A team that's calling on the same call point and so number one it's the G Y and we had the hospital team because theres a lot of women's that actually come in at the G. I level neurology orthopedic and then these women have their initial ultrasound and then go to a G Y and so we want to do a horizontal care pathway and the hospital and like Kylie actually go into that so it.
And the sales team, we see us and evolving from let's say a team of and this is hospital and core a team of you know lets say 20, and the core and another 10 and the hospital and over time, it's not initially going to be all this year, but over time I see that team going to closer to 60, so work.
And we're gonna methodically add and the markets that we have not been served well. We haven't served right now we're going to double down in states like New York, where now we've got this Medicaid contract and we are going to be really having a very efficient relay team between the community swell that we've built for the last year and also now.
You have a bolus of physicians and the community. Those physicians now are advocates at the hospital level, where we're turning on the hospital system. So with the bringing on Kylie Gotcha Ratner, who has the section chief at Yale and these two individuals have the discipline and the know how to convert health care.
Institutions. So that is really the core and we feel it and we've got to run a parallel path and well synchronized crew team, but a parallel path to actually get the hospitals and place. In addition to additional market share and adoption at the community base level.
So like Kylie also comment on the hospital strategy to give you more details. Thank.
Thank you Valerie so I I can add some specifics around and around the strategy and the tactical structure. So it essentially is a five pillar approach to creating standard of care. We have a core team of salary first spoke about that is the approach to the Chile and offices and then there's the net new helped us to this team that will be working to integrate and wrap.
And like adopt and to the hospital system disrupting the standard of care, there, which is currently Theo and 25. The third pillar of that is our integration later teams. So this is a team comprised of clinicians background and and the clinicians and and expertise and informatics. So they understand how to dive into workflow and how does that process and how to integrate into the and for that.
Ex overlays such as Emr's.
Fourth pillar is the synergy sales force, so that will be our decentralized platform, which will be applicable into certain health care environments as well as super groups and the fifth pillar of this as the marketing and commercial activation pillar, all working together and a matrix environment to disrupt the standard of care. The targeted approach that we've deployed is a three pronged approach and it.
And it's heavily data driven around ICD 10 codes C and 125 and covered lives contracts that we have so we've we've really structured North America two to approach. The places that were strongest first and the territory. It's eventually will be comprised of one core sales Rep. One hospital, a sales rep and and a.
Grace and lead and then coupled with a synergy counterpart that covers a few territories, all working and our collective matrix.
Yeah.
The hotel that filled you in in terms of the overall plan.
Yeah that was that was fantastic.
Fantastic.
Thanks, a lot and I wanted to touch on the Dana Farber, Brigham and and <unk>.
Partnership is walk, though I know, it's a research collaboration and makes sense, but could you, possibly talk about the economics and all I mean, they're just thinking about like the role that those groups will play and the regulatory process. The ultimate commercialization and think about the cash outlay over the next two years and then.
Any color there would be great and then can you just confirm.
And the new projects that come and results of that partnership that is and I'm going to be part of all the inherent and it sounded like the mrna technology from from that plus the oversight panel will be ultimately open or thank you Kyle.
Kyle I would say at a pretty astute and so let me I'll start and I'll, let a doctor and Northrop fill and so this is a research collaboration with experts and I Wanna say high risk early ovarian cancer detection and so they have spent a number of years honing this panel they publish.
Two papers and on a and set in and about 454 patients 34 per cent early stage. Our goal is to take this micro RNA and couple it with our protein component to actually have a combined algorithm and so we are now going to be starting additional I called proof of concept for the <unk>.
Combination and.
And then we will at that point, but we've already negotiated in terms of just the economics and getting back to your question. So we will be the commercialization engine, we will be paying them a royalty similar to likely pay Johns Hopkins and we will have exclusivity to the product and also that will be a product that combines our technology and their technology. So.
This is a way of us instead.
Instead of us developing on our own and spending I Wanna say years pluses specimens are so rare we are jumpstarting, our ova inherit what with the wood.
With taking on their technology, and and folding and with our technology I'll, let doctor and Northrop also comment on this as well.
Thank you Valerie I think one of the exciting things that so unique about coupling the transcriptome would the proteomics is that we can use the same sample type. So we can use the same serum sample from the patient and be able to identify both day unique micro RNA expression profile, that's indicative of the ovarian cancer as well as the pro.
Teen profile and in combination and by doing this this is where we're going to get that diagnostic accuracy of the disease and really be able to capture the early stage, though so that we're getting the patients before them and they have a higher survival rate and the other beauty of it is that we sense. It's from the same sample type we can combine these two.
Two targets on the same technology platform and so that this way we're not using two separate technology platforms. So we can create a high throughput technology process and our laboratory and then at the last unique point about this is by being able to combine this on the same technology, we can optimize that.
Technology, so that we can use smaller a blood sample volume. So we can use what's called like micro sampling. So eventually what we could do is actually launched this test and a D. T C. Like model. So that we could actually access Ah patient sampling directly to their home versus having to go to the clinic and utilize a clinician can concern.
And opportunity for the patient. So this way it really harnesses on the disease and really is able for us to broaden the patient population. So that we can test all women at risk for ovarian cancer.
Got it that was great. Thanks for that and I, just if I can.
And if I may just one last question from me with all of these updates and the initiatives I just was wondering if he.
The emphasis is on payer coverage or expanding the covered lives and I guess from 179 will be.
Priority and the near term or if you are okay, and 180 million lives number.
So Kyle and I would say that we're actually looking to put more resources on it not only for over but these products that are coming to market and a what I call a fast fashion and so the work that needs to go into oversight reimbursement strategy Ova inherit as well as endo check.
And that begins now so yes. We are we are first and foremost designing our trials of reimbursement and mine. If we don't change practice, we don't get paid and that is the you know that is the spinal cord of our study protocols, so absolutely supercritical and absolutely supercritical, even with our over products are studies that we're initiating a clinical utility and I'm looking at.
And 24 month outcomes, plus we have studies that have a long outcome data and theyre coming out of the Philippines and Israel. So those studies will be will be published within this year. If we believe.
Great sounds promising thanks, a lot for taking the time and congrats again.
Thank you Kyle.
Ladies and gentlemen, we have reached the end of today's question and answer session I would like to turn this call back over to MS. Valerie Palmieri for closing remarks.
And clothing, as we see progress and Covid vaccination and believe the restrictions Wilson will subside. We believe our organization is poised for strong growth and we will continue to do the right things to drive long term sustainability and value with our increased commercial footprint, a guideline endorsed and.
Differentiated test a differentiated portfolio of tests within the same call point of which three will be in place by Q4 of 2021 and now 54 per cent of the lives under coverage. We believe we are and the position to support continued growth and profitability.
And our end goal is to serve a large global pelvic mass population and overall women's health market with a platform coupled with proprietary science and data tools, which will drive better health and wellbeing to each patient and we serve and thank you for joining us today and we appreciate your support and.
The interest and aspire and women's health.
Okay.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and enjoy the rest of your evening.
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