ASPIRA WOMEN’S HEALTH INC. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) – Marketscreener.com

Posted: August 11, 2022 at 2:19 am

Forward-Looking Statements

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Forward-looking statements are subject to significant risks and uncertainties,including those discussed in Part I Item 1A, "Risk Factors," of our AnnualReport on Form 10-K for the year ended December 31, 2021, as supplemented by thesection entitled "Risk Factors" in this Quarterly Report on Form 10-Q, thatcould cause actual results to differ materially from those projected in suchforward-looking statements due to various factors, including our ability tocontinue as a going concern; our ability to comply with Nasdaq's continuedlisting requirements; impacts resulting from or relating to the COVID-19pandemic and actions taken to contain it; anticipated use of capital and itseffects; our ability to increase the volume of our product sales; failures bythird-party payers to reimburse for our products and services or changes toreimbursement rates; our ability to continue developing existing technologiesand to develop, protect and promote our proprietary technologies; plans todevelop and perform LDTs; our ability to comply with Food and DrugAdministration ("FDA") regulations that relate to our products and to obtain anyFDA clearance or approval required to develop and commercialize medical devices;our ability to develop and commercialize additional diagnostic products andachieve market acceptance with respect to these products; our ability to competesuccessfully; our ability to obtain any regulatory approval required for ourfuture diagnostic products; or our suppliers' ability to comply with FDArequirements

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for production, marketing and post-market monitoring of our products; ourability to maintain sufficient or acceptable supplies of immunoassay kits fromour suppliers; in the event that we succeed in commercializing our productsoutside the United States, the political, economic and other conditionsaffecting other countries; changes in healthcare policy; our ability to complywith environmental laws; our ability to comply with the additional laws andregulations that apply to us in connection with the operation of ASPiRA LABS;our ability to use our net operating loss carryforwards; our ability to useintellectual property; our ability to successfully defend our proprietarytechnology against third parties; our ability to obtain licenses in the event athird party successfully asserts proprietary rights; the liquidity and tradingvolume of our common stock; the concentration of ownership of our common stock;our ability to retain key employees; our ability to secure additional capital onacceptable terms to execute our business plan; business interruptions; theeffectiveness and availability of our information systems; our ability tointegrate and achieve anticipated results from any acquisitions or strategicalliances; future litigation against us, including infringement of intellectualproperty and product liability exposure; and additional costs that may berequired to make further improvements to our laboratory operations.Company Overview

?Growth. In 2022, we have continued to grow the top line in terms of bothproduct volume and revenue. Our focus has been on OVA1plus, and, in the secondhalf of 2022, we plan to drive OVA1plus sales volume not only through our owncommercial team but also through our collaboration with BioReference Health,LLC, formerly known as BioReference Laboratories, Inc. ("BRL"). We believeAspira GenetiX and Aspira Synergy should also contribute to increased revenue.In addition, positive trends in the tenure of our sales professionals shouldlead to volume growth. As of June 30, 2022, 67% of our sales professionals hadbeen with us for more than three months and 58% had been with us for more thansix months. We aim not only to increase the number of physicians ordering forthe first time but also to increase repeat orders from existing physiciancustomers.

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In parallel to building our OVA platform offering and our commercial deployment,we have been working on several key publications and product extensions.The OVAWatch manuscript, "Analytical Validation of a Deep Neural NetworkAlgorithm for the Detection of Ovarian Cancer," has been published online in theJournal of Clinical Oncology Clinical Cancer Informatics. The Company hasprepared an application for a Proprietary Laboratory Analyses code with the

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American Medical Association for the OVAWatch test to distinguish it fromOVA1plus with an expectation that Novitas and other payers will apply theOVA1plus Centers for Medicare & Medicaid Services fee to OVAWatch, ensuringconsistent coverage and pricing for both OVA products.COVID-19 Pandemic

In December 2019, a novel strain of coronavirus was reported to have surfaced inWuhan, China. The novel coronavirus has since spread to over 100 countries,including every state in the United States. In March 2020, the World HealthOrganization declared COVID-19, the disease caused by the novel coronavirus, apandemic, and the United States declared a national emergency with respect tothe coronavirus outbreak. This outbreak has severely impacted global economicactivity, and many countries and many states in the United States have reactedto the outbreak by instituting quarantines, mandating business and schoolclosures and restricting travel periodically throughout the pandemic. In orderto reduce the impact of limitations on visiting physician offices due toclosures and quarantines, we implemented other mechanisms for reachingphysicians such as virtual sales representative meetings, Key Opinion Leaderpresentations, and increased digital sales and marketing. Patient enrollment forour planned clinical research studies has been slower than originally planneddue to the impact of clinic closures and patients not seeking medical care insome states, which has led to delays in the completion of such studies.Given the potential for future resurgences of COVID-19 cases and the variety offederal and state actions taken to contain them, we are unable to estimate thepotential future impact of the COVID-19 pandemic on our business, results ofoperations or cash flows as of the date of the filing of this Form 10-Q.In addition, as of the date of the filing of this Form 10-Q, we haveapproximately four months of reagents, one of our key testing supplies, instock, depending on volume of tests performed, and we are working with themanufacturer to ensure a consistent supply over the next six months. Aspreviously disclosed, we have put in place staffing and reagent contingencyplans to ensure there is no down time at our lab. We believe the lab couldcontinue to operate in the event any isolated infection were to impact a portionof the workforce. The full impact of the COVID-19 pandemic continues to evolveas of the date of the filing of this Form 10-QCritical Accounting Policies and Estimates

Our product revenue is generated by performing diagnostic services using ourOVA1, OVERA, OVA1plus or Aspira GenetiX tests, and the service is completed uponthe delivery of the test result to the prescribing physician. The entiretransaction price is allocated to the single performance obligation contained ina contract with a patient. Under ASC Topic 606, Revenue from Contracts withCustomers, all revenue is recognized upon completion of the OVA1, OVERA,OVA1plus or Aspira GenetiX test and delivery of test results to the physicianbased on estimates of amounts that will ultimately be realized. In determiningthe amount of revenue to be recognized for a delivered test result, we considerfactors such as payment history and amount, payer coverage, whether there is areimbursement contract between the payer and us, and any developments or changesthat could impact reimbursement. These estimates require significant judgment bymanagement. For OVA1, OVERA, OVA1plus and Aspira GenetiX tests, we also reviewour patient account population and determine an appropriate distribution ofpatient accounts by payer (i.e., Medicare, patient pay, other third-party payer,etc.) into portfolios with similar collection experience. When evaluated forcollectability, this results in a materially consistent revenue amount for suchportfolios as if each patient account were evaluated on an individual contractbasis.

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Results of Operations - Three Months Ended June 30, 2022 Compared to ThreeMonths Ended June 30, 2021The selected summary financial and operating data of the Company for the threemonths ended June 30, 2022 and 2021 were as follows:

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Results of Operations - Six Months Ended June 30, 2022 Compared to Six MonthsEnded June 30, 2021The selected summary financial and operating data of the Company for the sixmonths ended June 30, 2022 and 2021 were as follows:

Product Revenue. Product revenue was $3,853,000 for the six months ended June30, 2022, compared to $3,136,000 for the same period in 2021. Revenue for ASPiRALABS is recognized when the OVA1, OVERA, or OVA1plus test is completed based onestimates of what we expect to ultimately realize. The 23% product revenueincrease is primarily due to an increase in OVA1 test volume compared to theprior year, partially offset by a modest decrease in AUP, which decreased from$377 in the first half of 2021 to $376 in the first half of 2022.Medicaid represents approximately 11.8% of volume in the six months ended June30, 2022, at an AUP of $90. This is compared to 11.7% of volume in the firsthalf of 2021, at an AUP of $90. Our OVA1plus AUP without Medicaid was $415 forthe six months ended June 30, 2022, compared to $417 for the same period in2021.The number of Product tests performed increased 23% to 10,257 during the sixmonths ended June 30, 2022, compared to 8,328 Product tests for the same periodin 2021. This increase was due to increased access to provider offices andincreased investment in our current commercial channel.Genetics Revenue. Genetics revenue was $106,000 for the six months ended June30, 2022, compared to $159,000 for the same period in 2021. Revenue for AspiraGenetiX is recognized when the Aspira GenetiX test is completed based onestimates of what we expect to ultimately realize. The 33% genetics revenuedecrease is primarily due to decreased volumes as compared to the same period in2021, in addition to the AUP decreasing to $424 from $483 from the same periodin 2021.

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Liquidity and Capital ResourcesWe plan to continue to expend resources selling and marketing OVA1, OVERA,OVA1plus and Aspira GenetiX and developing additional diagnostic tests andservice capabilities. We plan to launch our next generation ovarian cancer riskassessment test, OVAWatch, in the second half of 2022.We have incurred significant net losses and negative cash flows from operationssince inception, and as a result have an accumulated deficit of approximately$489,239,000 as of June 30, 2022. We also expect to incur a net loss andnegative cash flows from operations for 2022. Working capital levels may not besufficient to fund operations as currently planned through the next twelvemonths, absent a significant increase in revenue over historicrevenue or additional financing. Given the above conditions, there issubstantial doubt about our ability to continue as a going concern.We expect to raise capital through sources that may include public or privateequity offerings, debt financings, collaborations, licensing arrangements,grants and government funding and strategic alliances. However, additionalfunding may not be available when needed or on terms acceptable to us. If we areunable to obtain additional capital, we may not be able to continue sales andmarketing, research and development, or other operations on the scope or scaleof current activity, and that could have a material adverse effect on ourbusiness, results of operations and financial condition.As discussed in Note 2 to the condensed consolidated financial statements, inMarch 2016, we entered into a loan agreement (as amended on March 7, 2018 andApril 3, 2020, the "DECD Loan Agreement") with the State of ConnecticutDepartment of Economic and Community Development (the "DECD"), pursuant to whichwe may borrow up to $4,000,000 from the DECD.

As discussed in Note 3 to the condensed consolidated financial statements, onFebruary 8, 2021, the Company completed a public offering (the "2021 Offering")resulting in net proceeds of approximately $47,720,000, after deductingunderwriting discounts and offering expenses. There was a change in estimate inthe third quarter of 2021 in the amount of $138,000 relating to an expensereversal of offering costs.

In connection with a private placement offering of common stock and warrants wecompleted in May 2013, we entered into a stockholders agreement which, amongother things, gives two of the primary investors in that offering the right toparticipate in any future equity offerings by the Company on the same price andterms as

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Off-Balance Sheet ArrangementsAs of June 30, 2022, we had no off-balance sheet arrangements that arereasonably likely to have a current or future material effect on our condensedconsolidated financial condition, results of operations, liquidity, capitalexpenditures or capital resources.

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ASPIRA WOMEN'S HEALTH INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) - Marketscreener.com

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