Aspira Women's Health Inc.
Q4 2020 Earnings Call Transcript

Published: 25 Mar 2021

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to Aspira 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 Beechey, Chief Financial Officer; and Kaile Zagger, Chief Operating Officer; Dr. Lesley Northrop, 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.

[Valerie Palmieri:]

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 Kaile Zagger, 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 Sandford. 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 and health equity. Nic Sandford, a C.P.A., is currently the Executive Vice President and Global Board Services Leader at the Ellig Group. And prior to this role, she was a 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 woman's health company.

[Kaile Zagger:]

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 and the healthcare community and will subsequently and exponentially save the lives of the 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. In order to maximize and optimize our commercial position, we've 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 OVASight launch.

[Lesley Northrop:]

Thank you, Kaile. 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 woman's entire lifecycle starting with young adults with EndoCheck to our hereditary risk for cancer GenetiX, including high-risk diagnostic screening OVAInherit to benign mass monitoring OVASight. And lastly, our ovarian cancer risk assessment prior to surgery OVA1plus. 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, 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 OVASight clinical studies, as well as our international OVA1 and OVERA study sites in the Philippines and Israel. Both of these study 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 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 OVASight. 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 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 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 as this will be our third product launched under my leadership as CSO, first being the GenetiX platform and second being the Aspira Synergy GenetiX. I will now review our aid in diagnosis of endometriosis test known is 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 elagolix trial was submitted as part of the breakthrough device designation in January, and we are in dialog 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 and supported 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 OVAInherit 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 Lodz microRNA technology with diagnostic specificity in conjunction with our OVASight proteomic panel, which has high sensitivity as a potential diagnostic measurement of ovarian cancer. Currently, clinicians can order CA-125, the sub-optimal sensitivity and specificity in conjunction with ultrasound to access 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 and a 360 degree view, ensuring that we understand the patients' hereditary risk for gynecologic cancers with our GenetiX product to help prevent disease. Evaluating the acute risk for cancer in women with masses planned for surgery with OVA1plus 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 effect up to one in 10 women worldwide. This is the core goal of EndoCheck 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 it early as young adults. I would like to now turn the call back to Valerie. Valerie?

[Valerie Palmieri:]

Thank you, Lesley. 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 Medicine's initiative focused on combating women's reproductive cancers. This initiative resonates greatly with Aspira's mission and vision. Dr. Ratner?

[Elena Ratner:]

Thank you, Valerie. I am 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 and the strive for improving survival of ovarian cancer patients and changing the narrative of the disease. Today, survival ovarian cancer patient remains dismal and unacceptable. This is due in great part due to the challenges of early cancer detection as well as considerable racial health and inequities and management of the disease. We will have 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, great amount of funds is being invested and a great deal of research is being done in the fields of surgery and chemotherapy in the disease. And yet, 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 days has come for 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 the disease. Our end goal is to implement our technology is part of the care pathway at the institutional 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 a review of our financial results. Bob?

[Robert Beechey:]

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 OVA1 test volume compared to the prior quarter and a sequential price improvement per OVA1plus test performed to $364 compared to $338 in the third quarter. The number of OVA1plus tests performed increased 7% to 3,849 OVA1plus tests during the three months ended December 31,2020, compared to 3,596 OVA1plus 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 OVA1plus 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 31, 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 OVASight, 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 31, 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 secondary stock offering, resulting in net proceeds of approximately $48.4 million after giving effect to underwriting 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.

[Valerie Palmieri:]

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, as well as we strengthened our team and our board. I am proud of what we've 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 this 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 in 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 OVA1plus, coupled with our disparity differentiation and genetics testing will become the standard of care in pelvic mass risk assessment for ovarian cancer. For the longer term, we are moving ahead with our planned launches of OVASight, EndoCheck and lastly, OVAInherit. 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 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?

[Operator:]

Our first question comes from the line of Brian Weinstein with William Blair. You may proceed with your question.

[Andrew Brackmann:]

This is Andrew on today. Thanks for taking the questions. Maybe to start on the partnership announced today. Valerie, could you maybe just talk about sort of your level of confidence in bringing the products like this to market, which you just said technology, and I guess related to that, is there anything that you might be able to share with us around the development work that has been done so far to date, and when we should be thinking about any additional development updates from here?

[Valerie Palmieri:]

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 has been two papers published. This is a partnership that we started a couple of years ago in terms of evaluating their technology, and as you can hear the earnings script, it is focused on microRNA panel, so it's a collection of a panel. Harvard, as well as Dana Farber and Brigham and the University of Lodz 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 a very significant PPV and very high specificity. The study that was initially done is about 454 patients, and of that study about 34% of it was early stage.

[Andrew Brackmann:]

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 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 and for a broader uptick here?

[Valerie Palmieri:]

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 are 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.

[Andrew Brackmann:]

Perfect. And then, Bob, just one for you. Didn't forget about you here. One, 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.

[Robert Beechey:]

So, I think that Kaile referenced the fact that were expanding on, I think Q2 was 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 face 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 edge 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 the spending on the R&D. So, I think in those terms, that will 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 cash flow positive. That was our stated intention when we did the deal and we're staying with that.

[Operator:]

Our next question comes from the line of Kyle Mikson with Cantor Fitzgerald. You may proceed with your question.

[Kyle Mikson:]

So, I wanted to start on the OVASight acceleration. So I guess will the training of the sales force be any different for OVASight versus OVA1plus? And I guess, GenetiX, could you just talk about that, and then I really just want to help - I would love it if you could help me understand and think about the market size here, so I could get it on monitoring that, so that would be a few times a year. I think two to four times as we have said in the past, but in terms of pricing, like ASP, how much lower than a typical like $330, could that be ultimately? And I'll leave it there. Thanks a lot for the color.

[Valerie Palmieri:]

No problem. So Kyle, I'm going to start and then I'll let Kaile fill in as well. So, in terms of training of the sales force, 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 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 to surgery. Keep in mind pre-menopausal women had 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, 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 crosswalk to a similar OVA. I do think that there'll 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've three cohorts on the OVASight trial. The first cohort is an assessment of the risk of malignancy for benign masses those 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 1.2 million to 1.5 million women in terms of the use of the product that will be rolling out initially, that will be again subjective to the doctor and then we will be rolling out the 2 to 4 times per patient per year. So just Kaile wants to comment on the training that she is going to be putting in place for this new product.

[Kaile Zagger:]

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 segmentation 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.

[Valerie Palmieri:]

Did that answer your questions, Kyle?

[Kyle Mikson:]

Yes. Valerie and Kaile, thanks a lot for answering, that was great. And just stick with on the sales force and a little bit further, actually. So I guess currently could you just kind of talk about like where you currently going to stand and then when you increased 38%, I think I heard in the second quarter that would be like 27, 28 reps, where will like - will those take the typical six months to training and then where will I guess the - where will they be prioritized converted on because you're rolling out the new product and synergy, there's a lot of different things to kind of think about it if you're…

[Valerie Palmieri:]

Let me simplify it for you. So what we had is we have a 18, 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, 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 I'll let Kaile 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 today 20 in the core and then 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 between the community swell that we've built for the last year and also now we have both the physicians in the community. Those physicians now are advocates at the hospital level who were returning on the hospital system. So with the - bringing on Kaile, Dr. Ratner who is the section chief at Yale, these two individuals have the discipline and the knowhow to convert healthcare institutions. So that is really the core and we feel that we've got to run a parallel path and well synchronized protein, but at parallel path to actually get the hospitals in place in addition to additional market share and adoption at the community-based level. So I'll let Kaile also comment on the hospital strategy to give you more details.

[Kaile Zagger:]

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 help for this team that will be working to integrate and rapidly adopt into the hospital system disrupting the standard of care there which is currently CA125. 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 overlays such as EMR. 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 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, CA125 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 the synergy counterpart that covers a few territories all working in a collective metrics.

[Valerie Palmieri:]

So Kyle, given in terms of the overall plan.

[Kyle Mikson:]

Yes, that was fantastic. Thanks a lot. And I wanted to touch on the Dana-Farber Brigham and Lodz 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 like the role that those groups will play in the regulatory process, the ultimate commercialization, do you think about the cash outlay over the next, good years? And then - any color there would be great. And then can you just confirm if the new product that kind of results of that partnership if that going to be part of an inherent but it sounded like the mRNA technology from that plus the oversight panel will be ultimately OVAInherit? Thank you.

[Valerie Palmieri:]

Okay. Kyle, I would say you're pretty it's do. So let me start and I'll let Dr. Northrop fill in. So this is a research collaboration with experts and 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 a, as I said, 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 of 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 in 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 jumpstarting our OVAInherit with taking on their technology and then folding in with our technology. I'll let Dr Northrop also comment on this as well.

[Lesley Northrop:]

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 we sense it 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 platform 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.

[Kyle Mikson:]

And I just - if I may just one last question for me. With all these updates in the initiatives, I just was wondering if the emphasis on payer coverage are 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 live number?

[Valerie Palmieri:]

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 a, what I call, fast fashion. So the work that needs to go into oversight reimbursement strategy OVAInherit as well as EndoCheck that begins now. So yes, we are first and foremost designing our trials reimbursement in mind, if we don't change practice, we don't get paid and that is the spinal cord of our study protocols. So absolutely supercritical even with our OVA products, the studies that we're initiating on clinical utility and looking at 12 and 24-month outcomes plus we have studies that have long outcome data as they're coming out of the Philippines and Israel. So those studies will be published within this year we believe.

[Operator:]

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.

[Valerie Palmieri:]

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 into ours and differentiate test, a differentiated portfolio test within the same call point of which three will be in place by Q4, 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 Aspire Women's Health.

[Operator:]

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.