AUSTIN Aug 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Aspira Women's Health Inc earnings conference call or presentation Thursday, August 13, 2020 at 8:30:00pm GMT

Aspira Women's Health Inc. - Global Medical Director of Genetic Services

Aspira Women's Health Inc. - CFO

Aspira Women's Health Inc. - CEO, President & Director

Good afternoon, and welcome to Aspira Women's Health Second Quarter 2020 Conference Call. My name is Jessie, and I will be your coordinator for the call today. (Operator Instructions) As a reminder, this conference is being recorded today.

Leading the call today are Valerie Palmieri, President and Chief Executive Officer; Bob Beechey, Chief Financial Officer; and Dr. Lesley Northrop, Global Head of Innovation and Clinical Development. After the prepared remarks, we will open the call for Q&A.

Before we begin, I'd like to remind everyone that some statements made during the prepared remarks and the Q&A session, including statements relating to Aspira Women's Health expected future performance, future business prospects or future events or plans are forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the control of Aspira Women's Health. 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 in today's press release as well as the risk factors set forth in Aspira Women's Health annual report on Form 10-K filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements.

At this time, I would like to turn the call over to Valerie Palmieri, President and Chief Executive Officer. Valerie?

Valerie Barber Palmieri, Aspira Women's Health Inc. - CEO, President & Director [2]

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. This afternoon, we will review our second quarter 2020 accomplishments and financial performance. I'll also provide an update on our strategy to manage the near-term COVID-19 disruption as well as our longer-term plans to emerge stronger when the pandemic is behind us.

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 in the care pathway. It's all about getting the right patient to the right doctor and finding cancer at the earliest stage. This mission is the core of our company.

Let me first start with our new company name Aspira Women's Health, which now better reflects our organization's mission and vision. We have already established ourselves as a market leader for ovarian cancer risk assessment. But with this new name, we are also elevating our brand and highlighting our key focus on women's health. Women's health, or known as Femtech, is one of the fastest-growing sectors in health care. Through our data-driven approach, we aim to deliver solutions that help women aspire to take control of their gynecologic health and empower providers to deliver optimal care.

Keep in mind that our CLIA lab's name has always been ASPiRA LABS. So we already have a well-respected brand recognition with this name, and this was simply a matter of synchronizing our corporate name. Our website domain has been changed to Aspira Women's Health, and we have launched a new company logo and brand, CUSIP and stock symbol AWH. In summary, our team is very excited about this long overdue change to better reflect our vision to help globally transform women's health.

I am now moving on to the business update. I will focus first on the pandemic's impact on our company and what we've seen so far in the third quarter.

As I mentioned on our Q1 call, we continue to execute on our 4-part COVID strategy. Number one, first and foremost is our focus to ensure employee safety and business continuity. All office-based employees nationwide as well as on average, 60% of our sales team are still working remotely. While keeping their health and safety paramount, our sales team is able to enter the field on a limited targeted basis in accordance with local guidelines. We continue to expect limitations on the number of face-to-face customer calls for a period of time relative to specific geographies. We have also developed protocols and training for instances where physical visits are allowed to ensure both employee, customer and patient safety.

I'm now moving on to business continuity. Our lab operations requires on-site essential employees. As previously discussed, we have put in place staffing and reagent contingency plans to ensure 0 downtime.

The second part of our strategy is focused on cash preservation and liquidity management. We continue our efforts to reduce costs, such as travel, entertainment and discretionary spend while we are maintaining our commitment to critical product development. Bob will discuss our balance sheet and how we were able to strengthen it over the quarter in detail.

The third part of our plan is maximizing productive use of employee time and emerging from this crisis even stronger. In terms of productivity, our sales team is focused on maintaining close relationships with existing customers remotely, so that we can resume our sales trajectory upon return to normalcy. We developed a virtual territory management process using a number of tools. These tools include virtual sales rep visits, digital marketing, social media and a new provider/patient ordering portal. Regarding telehealth, we are also developing a process for our genetics offering, which will allow patients to access genetic testing directly.

The last part of our plan is to help our communities while continuing to work on our product pipeline development. Regarding community support, in the second quarter of 2020, we began offering COVID-19 antibody testing and began preparations for offering COVID-19 antigen testing. This testing is part of our presurgical risk assessment program as well as preparing for potential Connecticut State support. On June 10, we announced the completion of our laboratory validation of COVID antibody test as well as a laboratory validation of several additional oncology biomarkers, which we will also add to our presurgical risk test offering. We are offering the Roche Elecsys Anti-SARS-CoV-2 antibody assay, which has a 99.81% sensitivity and 100% specificity. The current turnaround time for this assay for a test is 24 to 48 hours. Our planned offering of COVID-19 antigen testing has been postponed due to manufacturer instrumentation delays. We are now planning to offer this test in late Q3 or early Q4 2020.

Regarding our product pipeline development, we've made several significant strides in the pipeline. And as a result, on the call today, we have Dr. Lesley Northrop, our Global Head of Innovation and Clinical Development. Dr. Northrop has been with the organization just over a year and has been leading all of our clinical trial and product development efforts. On the call today, she will provide a comprehensive update on our product development pipeline.

As you remember, our core focus last year was commercial adoption. For 2020, we are continuing our focus on commercialization, but we are also in-sourcing many of our development capabilities. Coupling our strong customer base, internalizing our development team, we are now looking to expedite trial enrollment. In fact, during COVID, we have seen improvements in enrollment with this approach.

The 2019 and 2028 advancements we have made in our protein technology, our genetic technology and now with a strong base of clinical practices will pave the way to build a strong portfolio of proprietary solutions which Dr. Northrop will discuss in detail.

Before I turn the call to Dr. Northrop, I would also like to discuss our commercial performance in Q2. As you know, we have a 2-pronged commercialization approach, direct sales and a platform strategy. We continue to believe that our platform strategy to penetrate large IDNs and OB/GYN super groups will pay off with accelerated adoption of our overall product pipeline.

The decentralized arrangement should help our products integrate into the care pathway of the respective institutions and super groups. These large deals have a significant lead time. And with the COVID-19 pandemic, it may slow down our efforts to finalize these deals. That being said, our partners continue to engage and are excited about the prospect of internalizing our technology. We will continue to work on this model as we seek to drive wider adoption of OVA1Plus in our expanded portfolio pipeline.

I am now moving on to our direct sales channel. We hit our low point in volume during the third week of April, as previously discussed. The volume is tracking at 40% to 50% of pre-COVID volume. This volume decrease was driven by 2 major factors. First, most hospital facilities eliminated all elective surgeries, and in the case of suspected late-stage ovarian cancer, biopsies were only performed to confirm malignancy and chemotherapy was administered without surgery. This allowed deferring primary surgery to reduce disease to a later safer time.

The second major factor affecting volume was deferral of annual visits. Relative to the scarcity of limited operating room capacity based on a survey of 124 customers, we saw that the majority of customers were using OVA1Plus to determine who needs surgery immediately or determine who can postpone surgery. In fact, based on the survey, 82% of these patients were high-risk or symptomatic, they needed to be seen with a high sense of urgency or post an ER visit.

After April's low point, we have seen a steady increase of volume. In fact, in May, the volume was at 60% of pre-COVID run rate; in June, it was at 74%; and in July and August, it is holding in the low 80% range. Keep in mind, this is during a time when major states such as Texas, Arizona and Florida, are experiencing a second wave of COVID, so we are encouraged by the rate of volume pickup that we are seeing with OVA1Plus.

In terms of total ordering physicians for the quarter, 1,789 physicians ordered OVA1Plus with 85% of these customers being repeat customers. The repeat customer rate of Q2 2019 was 73%. So even with the majority of our reps having limited face-to-face visits, we experienced a 16% improvement in the rate of repeat business year-over-year. This clearly illustrates the impact of our technology has on patient care, the stickiness of the technology and the overall retention and growth opportunity we have with our expanded portfolio with this customer base.

We have also activated our commercial organization to transform and perform in a virtual environment. As we expand our sales force, we do anticipate a change in the mix of our sales force to put a higher emphasis on inside sales personnel to maximize the effectiveness of those reps in the field.

In summary, we have 3 fundamental commercial pillars, which we are critically and acutely focused on. We are leading a virtual and nonvirtual commercial strategy together to expedite impact in the following ways. Number one, we are strategically magnifying our newly redesigned brand and its impact to the entire patient life cycle for the short term and the long term to drive clinical trial enrollment. We are also listing the awareness of this devastating nature of the disease of ovarian cancer, and the importance of the focus on women's health, coupled with the ovarian cancer awareness month, which occurs in September. And third, we are illuminating health care disparity awareness to advance clinical care pathways to earlier and more effective diagnosis.

Embodied in all 3 pillars are awareness and adoption-driving strategies, encompassing digital marketing, search engine optimization, social media, website initiatives, telehealth, and the construction of deep and wide virtual and nonvirtual clinical KOL teams across North America.

Overall COVID initially had a major impact on doctors' visits and elective surgeries. Despite these headwinds, we continue to execute on our 4-point strategy, which included stabilizing the business, managing our balance sheet, maximizing sales productivity and driving innovation to address a very large market opportunity.

At this point, I'll turn the call over to Dr. Lesley Northrop to share the progress on our innovation pipeline. Dr. Northrop.

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Lesley Northrop, Aspira Women's Health Inc. - Global Medical Director of Genetic Services [3]

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Thank you for the introduction, Valerie. I'm pleased to be on the call and look forward to meeting you all at future investor conferences. By way of background, I'm a molecular trained Ph. D., clinically boarded molecular geneticist and licensed laboratory director working in women's reproductive health diagnostics for the past 15 years.

Being on the forefront and changing clinical management, diagnostics and IVF and now oncology, I have landed the perfect position at Aspira Women's Health, and I'm excited to continue my life passion in bettering women's health at a company with an established foundation. I've been in Aspira Women's Health for the past year immediately diving into the company goals of taking study design concepts to launching trials, active recruitment and building upon our 10 years of R&D and clinical foundation as a pelvic mass and ovarian cancer expert. I've assembled a team of experts, moved Aspira Women's Health from an outsourced model to an in-source model and believe this will improve our ability to execute our new product pipeline.

The team includes bioinformatic scientists, clinical trial coordinator, data scientists and clinical research scientists to develop new technology with a goal of developing personalized medicine for some of the most significant gynecological diseases.

Let me now provide an update on our innovation pipeline and product enhancement. As despite the pandemic, we've been able to make progress on expanding our site selection from 2 sites pre-COVID up to 9 sites with continued enrollment.

Health care quality has been a core value of our company as we lead the charge for bringing ovarian cancer risk assessment disparity to the forefront. Health care disparity is becoming more recognized during COVID. As a result, we have added 3 additional sites to our study. Our #1 goal is to remove CA125 as a standard of care for all women at risk for ovarian cancer. As stated previously, we are enriching our 2 previously published studies to expand our published disparity evidence to support and to change the standard of care. We have not only engaged site initiation with Einstein Medical Center in Philadelphia, but we have also enrolled 3 additional sites in ethnically diverse population. The goal of this study is to validate OVA1 as there is disparity in cancer detection when testing across ethnically enriched population outside of Caucasian women as compared to CA125.

Based on our initial published data, OVA1 is 2.3x more sensitive in detecting ovarian cancer in African-American women than in CA125 or 79.2% versus 33.3% sensitivity using the 2007 ACOG cutoff metric. Second, I would like to update everyone on our third-generation ovarian cancer risk assessment test, which is now branded as OVANEX. Our last call, we briefly reviewed our IRB-approved prospective trial on OVANEX. OVANEX is designed to address the market 3x that of OVA1. Specifically, it is for women who have a benign mass and are currently monitored 2 to 4 times per year with CA125 and transvaginal ultrasound. We believe that this test will help clinicians and patients to better understand the risk of malignancy and if surgery can be delayed by monitoring the patient over time.

We have enrolled 7 practices to date which is up from 1 site in Q1 and are continuing our enrollment to allow us large adoption under the confines of this pandemic. We are tracking to launch of the product in phases, projecting the end of 2021 to early 2022.

OVANEX will be the protein foundation of our high-risk early detection solution of OvaInherit. The study is designed across 2 separate cohorts. Those asymptomatic women with a genetic predisposition and symptomatic women who are at risk due to being observed with a pelvic mass. This, coupled with OVA1, provides a solution for monitoring as well as a solution for surgical triage risk assessment.

Our next study is focused on OvaInherit. It's a real-time, multi-site study being performed with our current OVA and genetics commercial testing sites that are also established clinical research institutions. The name of this study is OVA360, providing us a 360 view in combining the established prevalence of protein with molecular targets of gynecological cancers. This study will explore specific genomic targets with the potential to define the key driver of female gynecological cancer, starting with ovarian cancer. We are developing a cell-free cell tumor, DNA-based test to identify early cancer development. This test is being developed as a multimodal, risk-based assessment test in combination with our already established 7 protein biomarkers plus molecular profiling, including transcriptomic and epigenomic patterns, RNA and methylation. This new test will interrogate bioinformatic solutions, such as machine learning, to monitor those who are genetically predisposed due to carriers of pathogenic variants and high prevalent genes associated with breast and ovarian cancer, for instance, BRCA1 and 2.

OvaInherit will have a new algorithm developed on symptomatic women first and then trained for cancer detection in the asymptomatic, high-risk predisposed population without a pelvic mass. Currently, clinicians can order CA125 in conjunction with ultrasound to assess risk of developing cancer. However, there is a lack of clinical utility and significant concerns on false positive/negative rates using the standard method that warrants a new biomarker surveillance test for early detection of ovarian cancer.

We believe that our algorithm will outperform this current standard of care and provide a precise measurement of tissue-specific type cancer as an early detection test. We will be partnering with key thought leaders in the genomics community to support the OvaInherit product.

Finally, we mentioned in our previous call, we are working on developing a future test which is in aid in detection of endometriosis, the brand name is ENDOCHECK. With the high clinical demand for a less-invasive test for early assessment of endometriosis, ENDOCHECK will address a total addressable market in the U.S. of a roughly 6 million to 7 million women. This is a large unmet need in the OB/GYN and IVF community as endometriosis is treated based on symptoms and may take up to 10 years to diagnose, sometimes with multiple surgeries.

We have leveraged our 10 years of research and rich biorepository of benign disease and have proven proficiency in being able to decipher endometriosis from nonendometriosis. Our end goal is to develop a test with sensitivity and specificity greater than laparoscopic biopsy. We are in the early phases of assay test validations and plan to launch our prospective clinical trial by the end of the year. We will be working with well-established pharmaceutical and academic institutions in collecting enriched sample cohorts to validate and perform our prospective trials. Our goal is to bring a noninvasive endometriosis detection solutions to the market to provide proactive management of this debilitating disease.

In summary, the goal of our research and clinical efforts is to launch new products that impact a woman's entire life cycle starting at puberty with ENDOCHECK, to her hereditary risk for cancer with genetics including high-risk screening with OvaInherit, to premenopausal benign mass monitoring with OVANEX and lastly, our ovarian surgical risk assessment, OVA1Plus.

I would like to now turn the call over to Bob for a review of our financial results. Bob?

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Robert Harry Beechey, Aspira Women's Health Inc. - CFO [4]

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Thank you, Dr. Northrop. Product revenue was $743,000 for the 3 months ended June 30, 2020, compared to $1.1 million for the same period in 2019. The 32% product revenue decrease is primarily due to a decrease in the number of our tests due to the impact of COVID. The number of OVA1Plus tests performed decreased 21% to approximately 2,458 OVA1Plus tests during the 3 months ended June 30, 2020 compared to approximately 3,129 OVA1Plus tests for the same period in 2019. The revenue per OVA1Plus tests performed decreased to approximately $295 compared to $324 for the first quarter. Included in the Q2 revenue and the average unit price were approximately $79,000 in onetime revenue adjustments related to prior periods, which account for $32 of the sequential decline. The slight increase after excluding onetime items was driven by realization of our new contract price from Cigna as of April 1, 2020, slightly offset by a decrease in the mix of Medicare patients who, given their demographic, had reduced visits to doctors as these older patients self-quarantined due to COVID. The decrease in the mix of Medicare patients was temporary as we have seen the mix of Medicare and Medicare Advantage patients revert back to historical pre-COVID mix in July.

Gross profit margin on OVA1 was 37% in the second quarter compared to 45% for the prior year period. Total operating expenses were approximately $4 million in the second quarter as compared to $4.2 million in the first quarter due to a decrease in nonrecurring expense items.

Our cash balance at June 30, 2020, was $10.9 million, not including the proceeds of our private placement which closed in the third quarter. Cash utilization for Q2 was $3.3 million compared to $3.8 million in the prior year. The cash utilization reflects the reduced volumes we experienced, primarily in April and May, offset by cost reductions we have taken during the pandemic.

Our cash position was impacted by 3 major factors: one, we received proceeds and warrants in the amount of approximately $5.1 million when our stock price maintained levels above $1.80 for 10 consecutive days on June 13, 2020. 100% of warrant holders exercised their warrants. Secondly, we were granted a loan, pursuant to the Payroll Protection Program, which was established under the CARES Act, which is being utilized primarily to fund payroll in the amount of approximately $1 million. We are using the proceeds alone in a manner that will qualify us for complete forgiveness of the loan under the terms of the CARES Act and the PPP. Third, we implemented cost controls and cash preservation measures to continue to curtail areas of natural savings, such as travel and entertainment. In addition, we curtailed the use of contractors and consultants and reviewed our entire vendor spend for savings. We're doing this while making modest, targeted investments in our digital and remote marketing capabilities.

As we previously announced, we also successfully amended the terms of our State of Connecticut financing with respect to the target employment levels in the state. We achieved the revised employment milestones during the second quarter and have submitted the requisite forms and are awaiting final approval and funding.

Lastly, subsequent to the end of the second quarter, we closed on our private placement for $11 million prior to transaction costs. This financing, together with cash on hand at the end of the second quarter and the expected financing from the State of Connecticut will enable us to execute on our product pipeline and continue to drive growth through targeted investments and refinement of our commercial team.

I'll now turn it back over to Valerie.

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Valerie Barber Palmieri, Aspira Women's Health Inc. - CEO, President & Director [5]

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Thank you, Bob. Before we open up 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. Our goal is to strengthen our overall commercial position so we emerge stronger post pandemic. In parallel, we are executing quickly on our larger mission to serve the 20 million women in the U.S. starting with ovarian cancer risk assessment, serial pelvic mass monitoring and eventually tackling the largest disease, endometriosis. Keep in mind, the hereditary ovarian cancer monitoring test, OvaInherit, is incremental to this market, and this product will be for women with and without a mass.

Ovarian cancer accounts for more deaths than any other cancer of the female reproductive system and is the only gender-specific cancer with greater than a 50% mortality rate. Our work in products are at the forefront of changing the standards of care and detection of ovarian malignancies. We believe we are helping close the gap in detection and, more importantly, survival for women.

In the near term, we believe 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 full steam ahead with our planned launches of OVANEX for pelvic mass monitoring, ENDOCHECK for endometriosis and lastly, OvaInherit for high-risk genetic predisposition monitoring.

We also believe in this new COVID era that health care 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 possible care. Our end in mind is the incorporation of our current technology with precision-based modalities to allow for noninvasive, early detection of gynecologic disease over the entire patient life cycle. As with our brand, we aspire a woman to take control of her gynecologic health and empower providers to deliver optimal care. In order to dive more into our name change, our expanded portfolio, and our scientific leadership, we will be holding a KOL call in September during ovarian cancer awareness month.

We are now happy to open up the call for Q&A and answer any of your questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Brian Weinstein with William Blair.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [2]

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This is actually Andrew on for Brian. Thanks for all the details in the pipeline. Valerie, maybe to start. You spoke a little bit in your prepared remarks when discussing how the product was being used in the quarter. But as we think about longer term here, I'm curious what your thoughts are on how COVID-19 changes the value proposition of your core offering today. And then have you seen any evidence already which gives you the confidence that your products are going to be sort of net winners in a post-COVID world? And if so, could you maybe talk a little bit more about that?

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Valerie Barber Palmieri, Aspira Women's Health Inc. - CEO, President & Director [3]

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Sure. Well, first off, thank you for the question, Andrew. And Brian sent me a note, so I knew that you were going to be on the call. So in terms of -- yes. So I think that when we first were told or we all were told nationwide that elective surgeries were on hold. And at first, we thought, wow, this is -- this could potentially be a major issue for us. And will they stop even utilizing OVA1 until elective surgeries are opened up. But what we saw was, and it was pretty quick when it bottomed out in middle of April -- middle of March to the middle of April, the middle April was the lowest point, we saw week-over-week volume coming back. And even with states, such as Florida, Arizona, California as well as Texas, which are big states for us, and we know they're already in a second wave of COVID, we're still seeing a lot of stickiness. And I think what's -- based on this 124 customer survey that we did, we saw that the test is being used at another level, meaning that the doctors -- there's pent-up demand right now for surgeries. There's pent-up demand in terms of just getting OR time and making sure you're taking the most-serious patient to the OR first. So we are seeing, is it a new application for the test? It's really it's on label use. But I think that now doctors are saying, I need just like going for a biopsy, whether it's a prostate biopsy or derm biopsy, I really need to assess this patient before I schedule the OR. So our goal is that it actually extends and that it actually -- as I said, we're looking at gathering the data and potentially writing a paper on how it's being used during COVID.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [4]

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Okay. Great. Thanks for the clarification on how it's being used. Maybe secondly, maybe for Dr. Northrop. You mentioned some potential biopharma and academic partnerships for the ENDOCHECK product and trial. Could you maybe give us an update on how those partnerships are intended to sort of assist in the development here? And then when should we be expecting to hear an update around any of those partnerships?

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Valerie Barber Palmieri, Aspira Women's Health Inc. - CEO, President & Director [5]

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Sure, Andrew. I'll start and then let Dr. Northrop fill in. So what you have seen and as everyone knows, if you read, whether it's pharma, whether it's any company, we have seen enrollment actually decline, right, because patients aren't going to the doctors. So I think there's a combination here is that the -- where we are starting these studies, we're starting them at large call points. And we already have very steep relationships due to some of the partnership things that we have in the queue. And so I think what you have here is as we laid the foundation last year and now when we're launching these studies, we're actually seeing quite an appetite to -- for these larger partners to join the study. So I'll let Lesley jump into some of the details, but it's actually been this -- I would say, this method at which we're gaining study partners has actually worked pretty well. Lesley?

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Lesley Northrop, Aspira Women's Health Inc. - Global Medical Director of Genetic Services [6]

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Yes. Thank you, Valerie. And nice to e-meet Andrew. Yes, we have some long-standing conversations, and we're in negotiation process with some large institutions that have enriched biorepository things where we're able to utilize their sample. And so right now, it's just more so hammering out the relationship, and how and when we'll get those samples. I can't give you a definitive date of when you could expect to hear an update, but there will definitely be something in the queue coming down the line here that we can hopefully make a formal announcement on where those samples are coming from and who are we receiving them from.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [7]

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Okay. Perfect. And then lastly, I know you referenced this in the past, but maybe for those a bit less familiar. Could you maybe talk a little bit more about the tech transfer product that you're developing? And then I guess as you go through that, could you maybe just describe the value that you think it brings to your customers?

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