Aspira Women's Health Inc.

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.

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.

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.