Financial Performance - The company has an accumulated deficit of approximately $498.9 million as of December 31, 2022, and expects to incur a net loss and negative cash flows from operations for 2023[168][181]. - Total revenue for the year ended December 31, 2022, was $8,184,000, a 20% increase from $6,812,000 in 2021[1]. - Product revenue increased by 21% to $7,970,000, driven by a 23% increase in OvaSuite test volume to approximately 21,423 tests[2][3]. - Genetics revenue decreased by 12% to $214,000, with a 32% drop in the number of tests performed due to the discontinuation of the genetics testing line[4][5]. - Total cost of revenue was $3,865,000, a slight increase of 3% from $3,750,000 in 2021, with product costs rising by 23%[6]. - Research and development expenses rose by 12% to $5,953,000, primarily due to costs related to sponsored research collaborations[7]. - Sales and marketing expenses decreased by 13% to $14,948,000, attributed to reduced employment and consulting costs[8]. - General and administrative expenses increased by 22% to $16,183,000, mainly due to insourcing corporate functions and increased personnel costs[9]. - Net loss for the year was $27,170,000, an improvement of 14% from a net loss of $31,662,000 in 2021[10]. - Cash used in operating activities was $32,185,000, primarily due to the net loss and changes in fair value of warrant liabilities[11]. - Net cash provided by financing activities was $8,544,000, resulting from the 2022 Offering, with net proceeds of approximately $7,675,000[12]. - The company has incurred significant net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[209]. Strategic Initiatives - The company plans to launch its second diagnostic algorithm, EndoCheck, for endometriosis diagnosis in the second half of 2023[166]. - The company aims to expand access to its tests among Medicaid patients and raise public awareness regarding the diagnostic superiority of Ova1Plus compared to CA-125[163]. - The company plans to continue commercializing Ova1Plus and expand managed care coverage in select markets in 2023[164]. - The company has established a Key Opinion Leader Network and added to its direct salesforce to support its commercialization efforts[164]. - The company is now credentialed to provide services to a total of 64 million Medicaid lives, representing 80% of the Medicaid population[213]. - A major global commercial payer agreed to cover OvaWatch effective April 1, 2023[213]. - The company plans to continue the development of a novel combined assay utilizing a new platform with collaborators, with Phase II collaboration beginning in 2023[215]. - The company added Medicaid coverage for multiple states, including Virginia and Pennsylvania, enhancing its market reach[212]. - The company has made significant advancements in its government strategy, including a requirement for CMS to develop a National Coverage Determination for multi-marker testing for ovarian cancer[212]. Financial Transactions - The company completed a public offering in 2021 resulting in net proceeds of approximately $47.86 million and another offering in 2022 with net proceeds of about $7.68 million[174][176]. - The company has entered into agreements to raise up to $22.5 million through equity offerings with Cantor Fitzgerald and Lincoln Park Capital[178]. - Payments of approximately $1.25 million are due for a sponsored research agreement with Harvard's Dana-Farber Cancer Institute, with 68% already paid[218]. Operational Challenges - The company has experienced labor shortages and may face future shortages of qualified employees, impacting its commercialization objectives[166]. - The company is engaged in two lease agreements, with one expiring on January 31, 2024, and the other on June 30, 2026[172]. Leadership Changes - Leadership updates include the appointment of a new Chief Financial Officer effective December 1, 2022[211]. Research and Development - The company published a paper validating the OvaWatch algorithm for ovarian cancer detection, highlighting its potential for early diagnosis[214].

Financial Data and Key Metrics Changes - Total product revenue for 2022 was $8.2 million, a 20% increase from 2021, with a fourth quarter revenue of $2.1 million, up 16% year-over-year [24] - Gross profit margin improved to 53% for the year compared to 45% in 2021, and 57% for the fourth quarter compared to 55% in the same period last year [24] - Cash used in operations for 2022 was $32.2 million, with an anticipated cash usage for 2023 between $16 million and $19 million [26][15] Business Line Data and Key Metrics Changes - Test volumes increased to 21,423 for the year, a 23% increase, with fourth quarter volume increasing 18% to 5,642 tests [24] - Ova1Plus test volumes contributed significantly to revenue growth, with the average unit price decreasing to $372 for the year [24][29] Market Data and Key Metrics Changes - The company is actively pursuing payer adoption and fair pricing for the OvaSuite test portfolio, achieving important milestones in 2022 [12] - OvaWatch received coverage from a leading global payer shortly after its launch, indicating positive market reception [12] Company Strategy and Development Direction - The company is focused on growth, innovation, and operational excellence, with a commitment to transparency and effective resource utilization [5] - Plans for 2023 include engaging in high-impact media and refining sales strategies to enhance provider adoption [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for OvaWatch and the overall market for ovarian cancer diagnostic tools, emphasizing the critical need for better diagnostics [27] - The company is navigating challenging market conditions while maintaining a focus on revenue growth and operational efficiency [15][49] Other Important Information - The company reduced its workforce by nearly 30%, resulting in significant payroll savings for 2023 [14] - A $12.5 million equity placement was established to enhance liquidity [15] Q&A Session Summary Question: What is the outlook for OvaWatch's average selling price (ASP) following national payer agreements? - Management indicated that establishing payer relationships takes time, but they are optimistic about aligning OvaWatch's ASP with Ova1Plus by the end of the year [29] Question: How are discussions progressing with potential partners for OvaWatch? - Management noted that reimbursement is a key factor for potential partners, and they are actively engaging with interested parties [31][32] Question: What needs to happen from a development and regulatory perspective before launching the endometriosis test? - The availability of high-quality samples for validation remains a challenge, and management is exploring various regulatory paths for the test [36] Question: What feedback is being received on OvaWatch, and is there any cannibalization of Ova1Plus? - Management reported no cannibalization of Ova1Plus and positive feedback from physicians regarding OvaWatch's utility [39] Question: What is the timeline for the serial monitoring assay for OvaWatch? - The company aims to launch the serial monitoring test in the second half of 2023, with ongoing clinical studies supporting its development [43]

Aspira Women's Health Inc. (NASDAQ:AWH) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Nicole Sandford - President and Chief Executive Officer Ryan Phan - Chief Scientific Officer and Chief Operating Officer Robert Beechey - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Griffin Soriano - William Blair & Company Operator Good morning, ladies and gentlemen, and welcome to Aspira Women’s Health Incorporated Third Quarter 2022 Conference ...

Aspira Women's Health, Inc. (NASDAQ:AWH) Q2 2022 Earnings Conference Call August 10, 2022 8:30 AM ET Company Participants Nicole Sandford - President and Chief Executive Officer Robert Beechey - Chief Financial Officer Ryan Phan - Chief Scientific Officer and Chief Operating Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Operator Good morning, ladies and gentlemen and welcome to Aspira Women's Health Inc. Second Quarter 2022 Conference Call. My name is Vikram and I will be your coordin ...

Call Start: 08:30 January 1, 0000 9:06 AM ET Aspira Women's Health, Inc. (NASDAQ:AWH) Q1 2022 Earnings Conference Call May 11, 2022, 08:30 ET Company Participants Nicole Sandford - President, Chief Executive Officer and Director Robert Beechey - Chief Financial Officer Michael Newton - Head, Commercial Conference Call Participants Brian Weinstein - William Blair & Company Ross Osborn - Cantor Fitzgerald & Co. Operator Good morning ladies and gentlemen and welcome to Aspira Women's Health Inc. First Quarter ...

Commercial Strategy and Product Development - The company aims to broaden its commercial focus from ovarian cancer to a range of gynecological diseases, leveraging its technology platform "Aspira Synergy" for distribution [202]. - The launch of the OVAWatch test is planned in two phases, with Phase I being a single-use test and Phase II allowing for serial monitoring, potentially tripling the addressable market compared to OVA1plus [203]. - A large prospective study with The Feinstein Institutes for Medical Research has been initiated to support the use of OVAWatch for high-risk women predisposed to hereditary ovarian cancer [219]. - The company plans to develop a new diagnostic algorithm, OVAInherit, to assess the risk of malignancy in genetically predisposed patients, integrating genetics and other modalities [203]. - The partnership with Genoox Ltd. aims to enhance data aggregation and analytics for better patient care and early disease detection [222]. - The company executed a strategic reorganization to enhance its national sales force and drive the adoption of OVA1plus as the standard of care for ovarian cancer risk detection [225]. Financial Performance - Total revenue for the year ended December 31, 2021, was $6,812,000, a 46% increase from $4,651,000 in 2020 [231]. - Product revenue increased by 45% to $6,568,000 in 2021, driven by a higher average revenue per test, which rose from $334 in 2020 to $378 in 2021 [232]. - The number of OVA1plus tests performed increased by 28% to approximately 17,359 tests in 2021 compared to 13,557 tests in 2020 [233]. - Genetics revenue rose by 126% to $244,000 in 2021, attributed to increased test volume and higher revenue per test [235]. - The company reported a net loss of $31,662,000 for the year ended December 31, 2021, compared to a net loss of $17,905,000 in 2020, representing a 77% increase in losses [231]. - The company has an accumulated deficit of approximately $471,728,000 as of December 31, 2021, and expects to incur further net losses in 2022 [244]. - Net cash used in operating activities for the year ended December 31, 2021, was $27,395,000, primarily due to a net loss of $31,662,000 [253]. - The Company expects to incur a net loss and negative cash flows from operations in 2022, with cash and cash equivalents projected to be sufficient for the next twelve months [252]. - Net cash provided by financing activities for the year ended December 31, 2021, was $48,378,000, mainly from a public offering that generated net proceeds of approximately $47,858,000 [255]. - The Company had $37,180,000 in cash and cash equivalents and $7,840,000 in current liabilities as of December 31, 2021 [251]. - The Company completed a public offering on February 8, 2021, resulting in net proceeds of approximately $47,858,000 [248]. Expenses and Financial Challenges - Research and development expenses surged by 153% to $5,314,000 in 2021, primarily due to costs related to OVAWatch and Aspira Synergy [238]. - Sales and marketing expenses increased by 93% to $17,086,000 in 2021, driven by higher personnel and promotional costs [239]. - General and administrative expenses rose by 60% to $13,257,000 in 2021, mainly due to increased personnel and legal expenses [240]. - The Company plans to continue investing in the marketing of its products and developing additional diagnostic tests despite ongoing financial challenges [244]. - The Company remains subject to an audit of the PPP loan, with no assurance that it will not be required to repay any portion of the loan [247]. - The Company obtained a PPP Loan of approximately $1,006,000, which was fully forgiven, resulting in a gain on forgiveness of debt of the same amount [247]. - The Company incurred net cash used in investing activities of $184,000 for the year ended December 31, 2021, primarily for property and equipment purchases [254]. Operational Challenges - The company has experienced labor shortages impacting its sales force, which may affect its commercialization objectives [204]. - The FDA has shown interest in the company's Breakthrough Device designation request for EndoCheck, which aims to expedite the development and review process for this diagnostic tool [215]. - The company has entered into a commercial enterprise agreement with Axia Women's Health, which includes over 400 providers and 150 women's health centers across multiple states [226].

Aspira Women's Health Inc. (NASDAQ:AWH) Q4 2021 Results Conference Call March 23, 2022 8:30 AM ET Company Participants Valerie Palmieri - Executive Chair of the Board Nicole Sanford - President and Chief Executive Officer Rob Beechey - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Kumar Raja - Brookline Operator Good morning, ladies and gentlemen, and welcome to Aspira Women's Health Inc.'s Full Year 2021 and Fourth Quarter 2021 Conference Call. My name is Kyle, and ...