Aspira Women's Health Inc.

Good afternoon, ladies and gentlemen, and welcome to Aspire's Women's Health Second Quarter 2021 conference call. My name is Shamali, 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 call is being recorded today. Leading the call today are Valerie Palmieri, President and Chief Executive Officer, Bob Beachy, Chief Financial Officer, and Kale Zager, Chief Operating Officer, and Dr. Leslie Northrup, Chief Scientific Officer, and Dr. Lena Ratner, Global Chief Medical Advisor, 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 this experience, 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 the spirit. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Participants are directed to the cautionary note set forth in today's press release, as well as the risk factors set forth in this year's annual report filled with the SEC, for a description of factors that could cause actual results to differ materially from those anticipated in the four leading statements. At this time, I would like to turn the call over to Valerie Palmieri, President and Chief Executive Officer. Valerie?

Thank you, Operator. Good afternoon, everyone, and thank you for joining us today. This afternoon, we will review our second quarter accomplishments, financial performance, as well as provide an update on our overall strategic developments. Our end in mind is to truly transform women's health, starting with ovarian cancer. Our goal is to eradicate late stage detection of ovarian cancer and ensure all our solutions will meet the needs of women for all ages, races, ethnicities, and stages of disease. We seek to develop a lifelong relationship with each patient from puberty to cure, ensuring each woman has access to the best in class diagnostics. Let me begin with a review of our core business. We are pleased to announce the growth of our revenue and volume despite COVID-19 restrictions. We reported second quarter over one only revenue of $1.72 million, an increase of 136% over prior year and 21% sequentially. Our over one product volume was 4,553 tests, which is up 85% compared to the same period last year and up 21% sequentially as well. This impressive outcome was driven primarily by growth of our customer base where strong commercial execution was bolstered by increased access to our physician customers, as well as a reflection of the initiation of our Salesforce expansion in Q2. Regarding our decentralized platform, Aspira Synergy, we are making progress, and the interest level is very high, as we have several deals in the pipeline. More to come on this front. I will now provide an update on a number of strategic developments regarding our pipeline, payer and evidence development, government affairs, and the additions to our senior leadership team. Before I move on to the pipeline, we have a significant paper that was just published this week and we'd like to discuss up front. The paper titled, Salvaging Detection of Early-Stage Ovarian Cancer Malignancies When COIN25 is Not Informative, has been published in a special ovarian cancer edition of Diagnostics. It is a 2,300 patient retrospective study to evaluate the performance of Oval-1 in a cohort of patients with low-risk serum CA-125 values. This study demonstrates the ability of Oval-1 to identify early-stage disease, while CA-125 reflected 0% sensitivity due to the low-risk cutoff. This paper further validates and supports the superior early-stage detection of ovarian cancer with Oval-1 versus the current standard of care in a large population. Dr. Ratner will be discussing this in detail later in the call. Now starting with our pipeline, I will review our EndoCheck breakthrough device program application. We continue to have a positive dialogue with the FDA regarding our planned EndoCheck product. In addition, we are very pleased to announce that we have signed a specimen collaboration agreement with our second pharmaceutical company, Obziva. Abziva is pursuing new treatments for endometriosis pain. We believe the specimen collaboration will advance our overall endometriosis research. Having two pharma companies contribute specimens demonstrates the critical need for a diagnostic. This collaboration between Abziva and Aspira represents a mutual dedication to create solutions to help the six to seven million women suffering with endometriosis by radically improving the time to diagnosis, as today it may take seven to nine years for a diagnosis. EndoCheck will allow patients to be treated appropriately and effectively without the need for unnecessary surgery. We are in very productive communications with the FDA regarding our Breakthrough Device Program application. Importantly, the FDA has acknowledged that there are many compelling reasons why this type of device is needed for both the treating physicians and for patients. The FDA has indicated they are very interested in continuing to work with Aspira on EndoCheck, and Aspira will be continuing our discussions with the agency on breakthrough device designation. I am now moving on to our second pipeline update regarding our Ovinherit product in collaboration with Dana-Farber Cancer Institute, Harvard. We are making very positive progress on our product collaboration with Dana-Farber Cancer Institute, which we disclosed in the first quarter. We expect to have data at the end of third quarter. Dr. Northrup will discuss this further in her section. Regarding our payer and evidence development, we have three major updates. Number one, first is the coverage of OVA-1 in the AIMS Specific Health Laboratory Medicine Clinical Guidelines. Oval-1 is now considered medically necessary according to the AIM specialty health clinical appropriateness guidelines. Notably, they have not included a competitive product called ROMA in their guidelines and consider it investigational and experimental. AIM is a member of the Anthem Blue Cross Blue Shield family of companies, which promotes optimal care through the use of evidence-based clinical guidelines and real-time decision support for both providers and their patients. AIM is a wholly owned subsidiary of Anthem, serving more than 50 million members across 50 states, including D.C. and U.S. territories. This represents an opportunity for an incremental 50 million increase to our total covered lives. We have commenced a targeted program to obtain contractual coverage with all of the AIM member plans. Moving on to number two. We also recently obtained coverage determinations from Highmark, Delaware, as well as Fidelis, New York, with contracts pending for both. In addition, we continue to gain traction with Medicaid, and are now being paid by California Medicaid. Our payer adoption strategy is making significant progress, and we believe inclusion in the AIM and EVACOR guidelines gives us further validation and credibility in our discussions with all health plans. Moving on to number three. On the evidence development front, we released our first analytical and initial clinical validation performance for Ovisight at ASCO 2021. Ovisight is a third-generation Ovid technology and is a laboratory-developed blood-based pelvic mass risk assessment test for ovarian cancer in a low-prevalence population. It was developed to increase specificity while maintaining high sensitivity with early-stage and allow for conservative management of women with a suspected benign mass who are not recommended for surgery. A total of 596 patients were tested from real-world patients to validate the oversight diagnostic algorithm. Validation data demonstrated 91% sensitivity, 89% specificity, and a negative predictive value of 99.6%, and a low-prevalence population of 3.8%. In addition, clinical sensitivity for all stages of disease, and more importantly, early stage sensitivity, was significantly better than CN125 as well. I am now moving on to the government affairs front. We are continuing to gain momentum post our congressional briefing. The company is actively engaged with Congress and several advocacy organizations, including Healthy Women, the National Ovarian Cancer Coalition, and the Ovarian Cancer Research Alliance in an effort to increase awareness about Oval-1 ovarian cancer and encourage legislation that provides financial support for additional trials. This also includes starting the discussions on the trial requirements for adding the company's ovarian cancer technology into guidelines, such as the U.S. Preventative Services Task Force, which would support the company's objective to launch a product that is more broadly applicable as a screening tool. The company will also be presenting to a congressional committee in September focused on women's healthcare access issues. In addition, the company is also working on the Medicare Innovation Technology Initiative to ensure coverage and reimbursement immediately following breakthrough approval for any of its products. And lastly, we have made significant addition to our leadership team Laura McPadden joined the company as head of people and culture. People are the core of our innovation and growth engine. Laura joins us with over 25 years' experience leading human resources and talent engines and providing strategic guidance for employee relations, performance management, talent acquisition, and organizational design. Before I turn the call over to Kylie to provide a commercial update, We are reaffirming the investment in sales and marketing and our investment in our pipeline. Our target launch date of oversight is on track for our fourth quarter of 2021 launch. This test initially will allow physicians to assess benign pelvic masses not recommended for surgery with much better performing technology versus CA-125. While our next revision of this technology will allow a mass to be monitored over time. This new test will leverage its high negative predictive value to assist in rule out, as well as its high PPV to assess risk of malignancy. In summary, we continue to work toward our overall strategic goal, which was to emerge from the pandemic stronger, and we believe we will continue to accomplish this irrespective of any resurgence in the COVID pandemic. We have had a faster than expected recovery with a limited sales force coming into Q2 as well. Our team is now stronger on all fronts with a solid financial position plus improved price appreciation year over year. And our development pipeline has matured with our third generation product expected to launch in Q4 2021. We are well positioned to invest, to grow, and to drive adoption. and most importantly, save lives. I would now like to turn the call over to Kylie Zager, our Chief Operating Officer. Kylie?

Thank you, Valerie. As Valerie mentioned, we are pleased with our revenue and volume progress in the second quarter. I will now provide an update on our overall commercial progress. We are continuing to execute on our overall commercial strategy with meaningful additions of talent. Based on the complexities of the patient journey through the health ecosystem, Coupled with the convoluted presentation of ovarian cancer, we have expanded and are deploying across our three direct sales channels. In support of these three verticals, we have invested additionally in critical support functions that will allow for rapid acceleration and adoption of our products into the clinical care pathway. Those supporting functions are commercial activation, enterprise integration solutions, and business analytics. We have aligned our strategies with the consolidation of the health systems and providers and the transition to the digital health in preparation for our much anticipated launch of Oversight. We are now also very focused on the establishment and development of our marketing and customer experience organizations. We are thrilled to welcome an acclaimed marketing executive, Jennifer Van Aken, to the organization to build and lead our marketing organization. Jennifer comes to us with deep CPG healthcare and private equity marketing experience and in under just two months has made significant strategic progress, commercial achievements, and key talent acquisitions within the organization. Starting with our core vertical, it has strong performance in Q2 with our three key metrics outperforming historic performance of the company. The team delivered unprecedented record volume and total customers. The total number of ordering physicians In the second quarter was 2,951, an increase of 65% over prior year and 14% sequentially. Our new customers were up 69% compared to the same period last year and up 7% sequentially. Q2 was the strongest quarter the company has seen across all drivers, accession, revenue, and ordering physicians. Regarding our health systems team, which we originated in March of this year, We have scaled it to six sales representatives as of July, and they are establishing a deep funnel of health systems that we are actively working with to transition the standard of care and bidirectionally integrate our solutions into the electronic system, which should allow for the ease of ordering and standard of care adoption across the network. We expect to be able to announce wins in this area in the third quarter. And lastly, our specialty force focused on our decentralized platform, Aspira Synergy. has executed a second agreement since product launch in Q1. This agreement will be announced shortly. In addition, we are in final stages of approval with a third agreement, which is one of the largest health networks in the United States. We believe that arrangements like this will form the fundamental building blocks to truly change the standard of care. Finally, the fundamental key to our strategy is the commercial activation activities that are fueling our Salesforce support functions namely marketing, business analytics, commercial activation, and the insourcing of enterprise implementation and solutions teams. I will now review high-level achievement of each of these teams. First, our marketing function has implemented a myriad of new commercial strategies, including the launch of multiple programs that reached over 300 new physicians in seven weeks, doubled the span of our digital and social media reach, and developed cutting-edge campaigns to penetrate the Medicaid and Medicare market adoption, resulting in four large new ordering positions with practices focused on Medicaid. We believe increasing awareness around ovarian cancer, signs and symptoms, and the fact we have strong differentiators for early detection, specific ethnicities, and insurance coverage are all critical factors in driving adoption at the provider and patient awareness level. Visits to our website have more than doubled from a year ago, and followers on Aspira's major social media platforms have increased year-to-date by double digits. In addition, we were present at ACOG and STO, held virtually in 2021, and we presented our Oversight Abstract at ASCO in June, which will be further discussed by Dr. Northrup later in the call. Our enterprise implementation and solutions team have rapidly expanded and is comprised of highly talented system engineers and industry experts in the digital informatics space. This team is working closely with our core, synergy, and health system verticals to build bi-directional integration interfaces to ensure we are well positioned to displace the standard of care and move the market towards a better solution for early detection of ovarian cancer. In summary, we have invested in our growth strategy by constructing deployment models, formulating very strong go-to-market positioning, and are now well positioned to capitalize on acceleration and adoption. We have increased the size of our growth organization by 75% since January of this year and continue to scale in preparation for the oversight launch in Q4. Specifically, regarding sales, we started the year with 15 sales representatives in our core verticals, and we now have 35 sales representatives across three sales verticals. Within these verticals, the majority of the representatives, to name 20 of them, were hired in the last three months. We truly believe we are positioned to accelerate adoption across the healthcare continuum while driving growth and delivering a stellar customer experience. We have an innovative portfolio of products that solves for an unmet need for a large population of women and we are now prepared to mobilize and change the standard of care. I would now like to hand the call over to Dr. Elena Ratner to provide an update on our momentum to becoming the standard of care and driving awareness of our technology and its impact on early stage risk detection of ovarian cancer specifically. Thank you, Kylie.