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spk06: Good afternoon, ladies and gentlemen, and welcome to ASEERA 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 management's 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 Kylie Zager, Chief Operating Officer, Dr. Leslie Northrup, Chief Scientific Officer, and Dr. Elena 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 Aspera's expected future performance future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the control of 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. Participants are directed to the cautionary note set forth in today's press release, as well as the risk factors set forth in a SPHERES annual report and third quarter 10Q files with the SEC. For factors that could cause actual results to differ, materially from those anticipated in a forward-looking statement. 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.
spk03: 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 accomplishments, our financial performance, as well as an update on our Q1 developments in terms of an acceleration of a product launch, a strategic agreement, and payer coverage. In addition, I will be introducing two of our newest members of our executive team, Dr. Elena Ratner, Global Chief Medical Advisor of Clinical and Translational Medicine, and Kylie Zager, our Chief Operating Officer. In addition to our executive team additions, we also recently appointed two new board members as well, Dr. Sandra Brooks, MD, and Nicole Sanford. Dr. Brooks is the Senior Vice President and Chief Medical Officer of Thomas Jefferson University Hospitals and is regarded in her field as a thought leader in health equity. Ms. Sanford, a CPA, is currently the Executive Vice President and Global Board Services Leader at the Ellie Group. And prior to this role, she was the National Managing Partner for Deloitte's 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 in 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 in the first half of 2022, 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 Overnext, 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 prevalence of disease and has a total available market, which is three times that of Oval One Plus, of 1.2 million patients per year. Second, I am very happy to announce we've entered into a significant strategic research collaboration agreement for the development and commercialization of an ovarian cancer detection test for high-risk women. The collaboration is with Dana-Farber Cancer Institute, Brigham and Women's Hospital, and the Medical University of Lutz. They have collectively published a novel microRNA panel, which we intend to use in combination with our current technology. We believe the high 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 an early-stage high-risk screening test. Dr. Northrup 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% of the population in the state. This is a significant add to serve the underserved population in New York, and this brings our total covered lives to 179 million, or 54% of the U.S. population, as of April 1, 2021. Number four, last month we completed a public offering for $45 million, which was oversubscribed, and this significantly strengthened our financial position. And finally, in March, we presented at the congressional briefing titled Advancing Health Outcomes for Women and Minorities. We delivered a call to action for OVA-1 as a standard of care for ovarian cancer risk assessment for Caucasian and non-Caucasian women in and the need to fund large race and ethnicity-based trials. I am now moving on to 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 weathered 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 teams. We also continue to advance our product pipeline and strengthen our financial position as well during 2020. Highlights of 2020 included seven major milestones. Number one, 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 in-network agreement added an additional 16 million lives to our contracted plans and and includes OVA-1 in addition to our ovarian and cancer genetic testing panels known as Aspira Genetics. Number two, we added to our Medicaid coverage with 13 new state plans. Major states added last year were Georgia, New Jersey, and South Carolina. With the addition of New York, our total credential Medicaid population now stands at 60 million lives, which is 78% of the U.S. Medicaid population. Having this coverage in place is so critical to managing the underserved population as we believe Oval-1 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 CN-125 in both early detection of ovarian cancer and the detection of ovarian cancer risk in 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. AbbVie agreed to provide us serum specimens, data, and clinical metrics from their Elagolix trial. These samples will support the development of EndoCheck. In the first quarter of 2021, we also submit an application to the FDA for breakthrough device designation and expect to have a dialogue with the FDA in the second quarter of 2021. Number five, as a patient-centric organization, we formed our own internal patient advisory board led by chief spokeswoman, Dr. Diane Powis. 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 Vermilion to Aspira Women's Health. The successful rebranding centered on our commitment to focus on women's health. In addition, we rebranded two products, Oven Next to Oversight and Aspira Genetics Technology Transfer to Aspira Synergy as well. And finally, we executed this year during extraordinary and unprecedented times. Before I turn the call over to Kylie, who will cover Aspira's commercial momentum in detail, I want to summarize the impact of our investment in commercialization and the progress we had. Our fourth quarter volume grew sequentially over third quarter by 7%. Our over one revenue was up 15% due to volume growth, as well as an 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 to emerge stronger from the pandemic, And we believe we have accomplished this with our stronger team, our stronger financial position, and our stronger pipeline. We are well positioned to invest, to grow, and to drive adoption, and most importantly, save lives. It is now my pleasure to turn the call over to Kylie Zager, a seasoned healthcare transformation executive whose experience spans across multiple healthcare industry disciplines. She brings extraordinary talent and abilities in building white space business verticals, disrupting standard of care with net new technologies, and elevating senior leadership teams to optimize performance. In a short period of time, Kylie has launched a commercial strategy that is preparing us to significantly scale our commercial operations for standard of care adoption. We are thrilled to welcome her to the executive ranks of Aspira Women's Health. I'd like to introduce Kylie.
spk05: 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 mission to me, early detection of gynecological disease beginning with ovarian cancer. Undoubtedly, we have a robust pipeline of products that are positioned to disrupt the standard of care in the healthcare community and will subsequently and exponentially save 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 life cycle of our products and overall value they bring to the patient. In order to maximize and optimize our commercial position, we have enhanced our strategic plan in the following ways. Number one, the repositioning and investment in core sales to capture 100% coverage of North America and strategically focus on significant practitioners that can and will impact the standard of care conversion. We are markedly focused on our racial disparities 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% in Q2 to prepare for continued growth as well as the Q4 oversight launch. Number two, we have launched a health systems team that will integrate our technology into clinical pathways across various ologies that intersect ovarian cancer patients and integrate into the complex workflow environments of these systems. With over 80% of physicians scheduled to be owned by health systems by 2023, we are confident that this strategy is critical and timely for our organization. Number three, We have set in motion an integration team comprised of highly experienced clinicians with informatics expertise. This team will work in a matrix to 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, both small and large. We are expanding the size of this organization with the intention of providing optimal communication, white-glove service, and create an impeccable experience for health systems, providers, and patients alike. We believe it will be a strong differentiator and contributor to the top-line growth. Number five, we have redeployed a synergy sales force to drive rapid adoption and penetration of our cutting-edge technology transfer platforms. This is our decentralized platform, which is focused on healthcare systems, physician labs, and clinics. Synergy will also expand access for all Aspira commercialized products, and future pipeline innovations will be blended into this Synergy platform. All commercial verticals are horizontally 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 both OVA1 plus and genetics as a solution offering. And finally, the glue to our strategy is 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 in the past 90 days and have amplified the focus around driving strong call to action campaigns across multiple channels. At the center of this strategy, we have placed the patient advisory boards. led by Dr. Diane Powis, our chief 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 constituents such as the FDA and the insurance community. Now I would like to pivot to Q4 performance and offer an insight into how the teams are performing in Q1. As Valerie mentioned, we delivered 7% sequential volume growth in the fourth quarter in the context of continued COVID-19 restrictions. These restrictions continued in the first quarter in our sales territories. In February, we also experienced some patient and delivery disruptions due to inclement weather. We are seeing a pickup in volume in March as the transformation strategies are gaining traction and the impact of the pandemic recedes. 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, 2,605 physicians ordered OVA1+, with 82% of the providers being repeat providers, consistent with our prior run rate. This clearly illustrates the impact that technology has on patient care, stickiness of the technology, and the overall retention and growth opportunity we have with our expanded portfolio. The number of ordering physicians increased 6% from the third quarter and flat year over year, signaling we are back to pre-COVID levels in Q4. I would now like to hand the call over to Dr. Northrup to provide an update on our innovation pipeline.
spk04: 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 in ovarian cancer risk assessment, We are creating a portfolio which is comprised of products that impact a women's entire life cycle, starting with young adults with endo check to our hereditary risk for cancer genetics, including high-risk diagnostic screening, OVA Inherit, to benign mass monitoring, OVA CITE. And lastly, our ovarian cancer risk assessment prior to surgery, OVA One Plus. We are continuing to increase our investment in R&D And one of our key investments is our efforts on closing the disparity gap in women's healthcare specific to the diagnostic accuracy of ovarian cancer detection. We have five active sites enrolled in our disparity clinical study. The most recent addition was Wayne State University in Detroit, Michigan as 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 2022. In parallel, we are continuing to recruit additional ethnic populations such as Hispanic, Black, Asians into our OVA site clinical studies, as well as our international OVA-1 and OVARA study sites in the Philippines and Israel. Both of these study sites are ending soon, and we are actively working on the data for multiple publication efforts. It is imperative We continue to capture and enrich population of women so that all of our current products and future products are pan-ethnic focused. Our second key investment is on our third generation ovarian cancer risk assessment test, which is now branded as Ovisight. 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 2022. This was driven by our belief in the clinical need to offer a risk assessment test 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 test allows physicians to clearly classify masses as low or high risk for 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 will 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 as this will be our third product launched under my leadership as CSO. first being the Genetex platform and second being the Aspire Synergy genetics. I will now review our aid and diagnosis of endometriosis tests known as EndoCheck. We believe there is market demand for a 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. EndoCheck 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 the ELIGOLIX trial was submitted as part of the breakthrough device designation in January, and we are in dialogue with the FDA. In addition, we received access to another valuable specimen bank from a consortium of six academic centers entitled EndoMarker Study. This study was funded by NICHD in support of the Reproductive Medicine Network on Endometriosis Research. These specimens will support additional validation efforts of EndoCheck. Additionally, we are in an early proof of concept of our ova-inherent test, a diagnostic test 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, Brigham and Women's Hospital, and the Medical University of Lutz microRNA technology with diagnostic specificity in conjunction with our ovocyte proteomic panel, which has high sensitivity, as a potential diagnostic measurement of ovarian cancer. Currently, clinicians can order CA-125 with suboptimal sensitivity and specificity in conjunction with ultrasound to assess risk in this patient population. We feel the combination of proteins and transcriptomics will 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, we are circling the ovarian cancer disease state in a 360-degree view, ensuring that we understand the patient's hereditary risk for gynecologic cancers with our Genetics product to help prevent disease, evaluating the acute risk for cancer in women with masses, plan for surgery with OVA1+, and those where a monitoring strategy may be more appropriate with OvaSight, and moving towards a diagnostic test for women at high risk with OvaInherit. But our greater goal as a company is to improve women's overall health. To do so, we must address other gynecologic disease states like endometriosis that affect up to 1 in 10 women worldwide. This is the core goal of EndoJet. as an aid in diagnosis of endometriosis. We believe EndoCheck will provide a life-changing disease modification by enabling early diagnosis and treatment for women starting as early as young adults. I would like to now turn the call back to Valerie. Valerie?
spk03: Thank you, Levly. Before we have Bob provide an update on our financials, I would like to introduce Dr. Elena Ratner. Dr. 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. 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 Aspira's mission and vision. Dr. Ratner.
spk02: Thank you, Valerie. I'm delighted to join the call this afternoon. Aspira's mission is to provide women with truly personalized ovarian cancer risk assessment and to enable early ovarian cancer detection for women of all ages, ethnicities, and races, which is the core of my research and clinical practice as I strive to for improving survival of ovarian cancer patients and changing the narrative of this disease. Today, survival of ovarian cancer patients remains dismal and unacceptable. This is due in great part due to the challenges of early cancer detection, as well as considerable racial health inequities in management of the disease. Women of color, especially African American women, continue to have significantly lower five-year survival rates than Caucasian women. There are many factors which drive this, but having access to the best risk assessment technology in order to improve early stage cancer detection is critical. For generations, a great amount of funds is being invested and a great deal of research is being done in the fields of surgery and chemotherapy in this disease. And yet, a great majority of ovarian cancer patients still die from this cancer. This is due in great part to the delay in early stage diagnosis, making it clear and urgent that the day has come for a better ovarian cancer early detection test, better 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 at the institution level so that our 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 a view of our financial results. Bob?
spk01: Thank you, Dr. Ratner. Good afternoon, everyone. I'm delighted to be here, and I welcome our new team members. As discussed, we've had continued volume growth in the fourth quarter, and now I'd like to make some high-level comments on the financials Product revenue was $1.4 million for the three months ended December 31, 2020, compared to $1.2 million for the third quarter. The 17% sequential increase is primarily due to an increase in number one test volume compared to the prior quarter and a sequential price improvement per over one plus test performed to $364 compared to $338 in the third quarter. The number of Oval One Plus tests performed increased 7% to 3,849 Oval One Plus tests during the three months ended December 31, 2020, compared to 3,596 Oval One Plus tests performed for the third quarter. The volume increase was primarily due to our commercialization investment and a further increase in patient doctor visits as patients have adjusted to the COVID environment. Gross profit margin on over one plus was 50% in the fourth quarter as compared to 45% in the third quarter driven by improved volume and improved price realization. Research and development expenses for the three month ended December 31st, 2020 were 735,000, a 24% increase from the third quarter level of 594,000. This increase was primarily due to product development costs related to oversight as well as investments in bioinformatics and Aspira Synergy. Sales and marketing expenses for the three months ended December 31, 2020, were $2.8 million compared to $2.2 million in the third quarter, a 32% increase. This increase was primarily due to increased expenditures on marketing to improve awareness, as well as slightly higher travel and entertainment as COVID-19 pandemic restrictions slightly eased and investments in the commercial team. General and administrative expenses for the three-month period ended December 31st, 2020, were $2.7 million compared to $2 million in the third quarter, a 39% increase. This increase was primarily due to an increase in legal expenditures as well as board of director fees as we settled the fourth quarter installment of board-restricted stock units in cash to defray tax liabilities which arose in connection with RSU grants earlier in the year. Our total cash utilization in the fourth quarter was $4.2 million compared to $3.1 million in the prior quarter. The fourth quarter included $428,000 related to the one-time cash settlement of restricted stock units. The remaining sequential increase in cash utilization was due to the increased investment in marketing and awareness, as well as the investment in commercial and R&D. We ended the year with approximately $16.6 million in cash. On February 8, 2021, the company completed a secondary stock offering resulting in net proceeds of approximately $48.4 million after giving effect to under-rated discounts but before expenses. We believe the current strength of our balance sheet enables us to properly fund both the commercial and innovation opportunities facing the company. I'll now turn it back to Valerie.
spk03: 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. In a year dominated by the pandemic, we delivered record enterprise value, growth, financial stability, and 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 healthcare burden and reducing significant inefficiencies in the care pathway. It's all about getting the right patient to the right doctor and finding the cancer at its earliest stage in 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. 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 in detection and, more importantly, survival for women. In the near term, we believe Oval One Plus, coupled with our disparity differentiation and genetics testing, will become the standard of care and pelvic mass risk assessment for ovarian cancer. For the longer term, we are moving ahead with our planned launches of Ovisite, EndoCheck, and lastly, Ovinherit. We also believe in 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 and ensure that all women of every socioeconomic background receive the best care possible. We are now happy to open the call for Q&A and answer any of your questions. Operator?
spk06: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation film will indicate your line is in the question queue. You may press star 2 to remove your question from the queue. For participants using speaker equipment, it may 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.
spk09: Hi, good afternoon. This is Andrew on the day. Thanks for taking the question. Maybe to start on the partnership announced today, Valerie, could you maybe just talk about sort of your level of confidence in bringing a product like this to market using this technology?
spk08: And I guess related to that, is there anything that you might be able to share with us around the development work that's been done so far today and when we should be thinking about any additional development or validation updates from here?
spk03: Hi, Andrew. Good afternoon. Thank you for joining. Your line was going in and out a little bit, so I don't know if it's your line or our line. I'm hoping it was your line. So a couple of things. There's been two papers published. This is a partnership that we started a couple years ago in terms of evaluating their technology. And as you can hear from the earnings script, it is focused on microRNA panels. So it's a collection of a panel. Harvard, as well as Dana-Farber and Brigham and the University of Lutz, have 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 significant PPV. We haven't stated the PPV in public domain, but we can send you the papers. And it's very significant PPV and very high specificity. The study that was initially done was about 454 patients. And of that study, about 34% of it was early stage.
spk09: Great. Thanks for that. And then maybe just following up here and recognizing it's still pretty early in 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? I guess really sort of what levels of sensitivity and specificity at that early stage should we be thinking about for broader uptake here?
spk03: So I would say that two things is that the colorectal screening guidelines just came out, right? And honestly, I thought that the performance metrics were on the lower side. We are aiming something in that 95-95 range. Ideally, we'd like to get our specificity up to that 99%, but I want to say 95-95 is kind of what we are aiming for.
spk09: Perfect. And then, Bob, just one for you. Didn't forget about you here. One, you know, with the number of initiatives ongoing, how should we be thinking about the OPEX and cash burn for 2021 and pacing of that throughout the year? Thanks for taking the question.
spk01: So I think that, you know, Kylie referenced the fact that we're expanding on. I think Q2 is the area where we're going to have a little bit of cost investment 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 I think the ads phased over Q1 in that team will be in the high single digits. And we're also looking at some IT investment as well. as well as the spending on the R&D. So I think, you know, I think in those terms that we'll be phasing over time and as the hospital group starts to turn revenue in the third quarter, a 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 having that bridge us to castro positive that was our stated intention when we did the deal and we're staying with that great thanks everyone thank you andrew 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
spk06: Nixon with cancer Fitzgerald. You may proceed with your question.
spk07: Hi, guys. Thanks for taking the questions. Congrats on all the great updates. So I want to start on the oversight acceleration. So I guess will the training of the Salesforce be any different for oversight versus one plus and I guess genetics to talk about that. And then I really just want to help. I would love it if you could help me understand how to think about the market size here so I can get it. I'm monitoring tests, so that would be a few times a year. I think two to four times we've said in the past. But in terms of pricing, like ASB, how much lower than the typical, like, you know, 330, could that be ultimately? And I'll leave it there. Thanks a lot for the comment.
spk03: No problem. So, Kyle, I'm going to start, and then I'll let Kylie fill in as well. So in terms of training of the Salesforce, it's the same call point. So number one, same call point. And we've been selling a product in terms of a risk assessment where a woman, a doctor assesses a woman to understand which doctor to do the surgery. What doctors are really looking for is they really want to test 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 low risk patients who did not move forward surgery. Keep in mind, premenopausal women have the largest number of pelvic masses, and a lot of those women are fertile. So surgery is something that is of top of mind. So that's number one. Number two, in terms of ASP, the ASP initially that we will be rolling out will be more of a stacked code version initially, but we will be going for an AMA code just like we did with OVA. So it will be crosswalked to a similar OVA. I do think that there will be some pricing discounts on this 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 an initial product that is not for serial monitoring. I just want to make that clear. So we have three cohorts on the oversight trial. The first cohort is an assessment of the risk of malignancy for benign masses. Those, the patients, are not planned for surgery. So it's a one-time use. If 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 TAM, I would say that the TAM that we have is 1.2 to 1.5 million women In terms of the use of the product that we'll be rolling out initially, that will be, again, subjective to the doctor, and then we'll be rolling out the two to four times per patient per year. So just Kylie wants to comment on the training that she's going to be putting in place for this new product.
spk05: Hi, thank you so much. Yes, we have a robust go-to-market in place 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 in this as of June. So we have a three-month lead time of getting everyone integrated, getting up to speed on the products, understanding the new market segmentations that we are approaching and how to do this so that we can rapidly penetrate and drive towards standard of care adoption as quickly as possible. Does that answer your question, Kyle?
spk07: Yeah, Valerie and Kyle, thanks a lot for answering that. That was great. And just think about the sales force a little bit further, actually. So I guess currently, could you just kind of talk about like where you currently kind of stand? And then when you increase 30%, I think I heard in the second quarter, that would be like 27, 28 reps. Where will, like, you know, will those take the typical six months to train? And then where will, I guess, where will they be prioritized from early on? Because you're rolling out the new product and synergy, there's a lot of different things to kind of think about if you're
spk03: Yes, let me simplify it for you. Let me simplify it for you. So what we have is we have a team that's calling on the same call point. So number one, it's the GYN. We have the hospital team because there's a lot of women that actually come in at the GI level, the urology, orthopedic, and then these women have their initial ultrasound and then go to a GYN. So we want to do a horizontal care pathway in the hospital and let Kylie actually go into that So in terms of sales team, we see us evolving from, let's say, a team of, and this is hospital and core, a team of, let's say, 20 in the core and another 10 in 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 we're going to methodically add In the markets that we have not been served, where we haven't served right now, we are 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 that we have a bolus of physicians in the community, those physicians now are advocates at the hospital level. We're turning on the hospital system. So with the bringing on Kylie, Dr. Ratner, who is the section chief at Yale, these two individuals have the discipline and the know-how to convert healthcare institutions. So that is really the core, and we feel that we've got to run a parallel path, a well-synchronized crew team, but a parallel path to actually get the hospitals in place in addition to additional market share and adoption at the community-based level. So let Kylie also comment on the hospital strategy to give you more details.
spk05: Thank you, Valerie. So I can add some specifics around the strategy and the tactical structure. So it essentially is a five-pillar approach to creating standard of care. We have the core team, as Valerie first spoke about. That is the approach to the GYN offices. And then there is the net new health systems team that will be working to integrate the and rapidly adopt into the hospital system, disrupting the standard of care there, which is currently CA-125. The third pillar of that is our integration leader team. So this is a team comprised of clinicians, background in the clinicians, and then expertise in informatics. So they understand how to dive into workflow, how to assess process, and how to integrate into the informatics overlay, such as EMRs. Fourth pillar is the Synergy Salesforce. So that will be our decentralized platform, which will be applicable into certain healthcare environments. as well as supergroups. And the fifth pillar of this is the marketing commercial activation pillar, all working together in a matrix environment to disrupt the standard of care. The targeted approach that we've deployed is a three-pronged approach, and it's heavily data-driven around ICD-10 codes, CA-125s, and covered lives contracts that we have. So we've really structured North America to approach the places that we're strongest first, And the territories eventually will be comprised of one core sales rep, one hospital sales rep, an integration lead, and then coupled with a Synergy counterpart that covers a few territories, all working in a collective matrix.
spk03: We hope, Kyle, that filled you in in terms of the overall plan.
spk07: Yeah, that was fantastic. Thanks a lot. And I wanted to touch on the Dana-Farber, Brigham, and Ludd's partnership as well. So I know it's a research collaboration, makes sense, but could you possibly talk about the economics at all? I mean, just thinking about the role that those groups will play in the regulatory process, the ultimate commercialization, just thinking about the cash outlay over the next few years, and then any call there would be great. And then can you just confirm if the new product that kind of results of that partnership, if that is going to be part of OVA Inherit because it sounded like the mRNA technology from that plus the OVA site panel will be ultimately OVA Inherit. Thank you.
spk03: Yes. Kyle, I would say you're pretty astute. So let me start and I'll let Dr. Northrup fill in. So this is a research collaboration with experts in, I want to say, high-risk early ovarian cancer detection. So they have spent a number of years honing this panel. They've published two papers on, as I said, an N of about 454 patients, 34% early stage. Our goal is to take this microRNA and couple it with our protein component to actually have a combined algorithm. And so we are now going to be starting additional, I call proof of concept, so the combination. And then we will at that point, but we've already negotiated in terms of just the economics, Getting back to your question, so we will be the commercialization engine. We will be paying them a royalty similar to like we 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 of us developing on our own and spending, I want to say years, plus these specimens are so rare, we are jump-starting our over-inherit with the with taking on their technology and then folding in with our technology. I'll let Dr. Northrup also comment on this as well.
spk04: Thank you, Valerie. I think one of the exciting things that's so unique about coupling the transcriptome with 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 the unique microRNA expression profile that's indicative of the ovarian cancer as well as the protein profile And in combination 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 so that we're getting the patients before and they have a higher survival rate. The other beauty of it is that since it's from the same sample type, we can combine these 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 in 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 the technology so that we can use smaller blood sample volume. So we can use what's called like micro sampling. So eventually what we could do is actually launch this test in a DTC like model. so that we could actually access patient sampling directly to their home versus having to go to the clinic and utilize clinician consent 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.
spk07: Got it. That was great. Thanks for that. If I may, just one last question for me. With all these updates and the initiatives, I just was wondering if the emphasis on payer coverage or expanding the covered lives, I guess, from 179 will be a priority in the near term, or if you're okay with that kind of 180 million lives number.
spk03: So, Kyle, I would say that we're actually looking to put more resources on it, not only for OVA, but these products that are coming to market in what I call a fast fashion. So, the work that needs to go into oversight reimbursement strategy, over-inherit as well as endo-check, you know, that begins now. So, yes, we are first and foremost designing our trials or reimbursement in mind. 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 super critical, absolutely super critical even with our over-products. There are studies that we're initiating on clinical utility. I'm looking at 12- and 24-month outcomes. Plus, we have studies that have long outcome data that are coming out of the Philippines and Israel. So those studies will be published within this year, we believe.
spk07: Great. Sounds promising. Thanks a lot for taking the time. And congrats again.
spk03: No, thank you, Kyle.
spk06: 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.
spk03: In closing, as we see progress in COVID vaccinations and believe the restrictions 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 test within the same call point, of which three will be in place by Q4 of 2021, and now 54% of the lives under coverage, we believe we are in a position to support continued growth and profitability. Our end goal is to serve a large global pelvic mass population in overall women's health market with a platform coupled with proprietary science and data tools which will drive better health and well-being to each patient we serve. Thank you for joining us today. And we appreciate your support and the interest in Aspira Women's Health.
spk06: 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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