Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Launch of the longitudinal mass monitoring application for OvaWatch, expanding the clinical utility and commercial opportunity for the OvaSuite portfolio.
- Significant increase in the total addressable market for OvaSuite tests, now estimated between 2 million and 4 million tests per year.
- Positive momentum from the commercial strategy refresh, resulting in sequential growth and a new high watermark of 6,471 OvaSuite tests in Q2 2024.
- Successful addition of new commercial and Medicaid coverage, including Anthem Plans in California and the Northeast, and Blue Cross Blue Shield of Texas and Illinois.
- Meaningful increase in Medicare and Medicare Advantage reimbursement for OvaWatch in the first half of 2024.
Negative Points
- Slight decrease in gross margins to 59% compared to 62% last year due to increased product costs, including higher shipping costs.
- Research and development expenses increased by 37% year-over-year, driven by collaboration costs with research partners.
- Sales and marketing expenses increased by 21% over the second quarter of the prior year due to higher personnel costs.
- Cash used in operations was $3.7 million in Q2 2024, a slight increase of 9% compared to last year.
- The company's cash position as of June 30, 2024, was approximately $962,000, necessitating new funding arrangements and cost containment measures.
Q & A Highlights
Q: Can you parse out growth between increasing utilization by existing customers versus attracting new doctors to Aspira's portfolio?
A: Growth has been consistent across both categories. We continue to bring on new providers and see growth in existing provider adoption. - Nicole Sandford, CEO
Q: Do you plan to submit OvaWatch for FDA approval, and can you walk through that process?
A: We are holding off on FDA clearance for OvaWatch to accumulate additional clinical utility data. OvaWatch can remain as an LDT indefinitely, but we have the option to clear it before mid-2028 if needed. - Sandra Milligan, President
Q: Will John Kallassy be considered for a full-time CFO hire?
A: John Kallassy has been brought in as an interim CFO, but we will keep all options open for a long-term CFO position. - Nicole Sandford, CEO
Q: How do you envision the growth of OvaWatch with the implementation of longitudinal monitoring?
A: We expect a faster ramp-up for OvaWatch compared to Ova1Plus, given the existing familiarity and trust among providers. The growth should be steady but faster than previous launches. - Nicole Sandford, CEO
Q: Have you received any feedback on the level of physician enthusiasm about the publications and mass monitoring with OvaWatch?
A: The reception has been very positive, especially regarding the utility of the test for pre-menopausal and asymptomatic women. The new data and longitudinal monitoring application have been warmly received. - Nicole Sandford, CEO
Q: What are the next steps for enhancing OvaSuite, and do you have any current plans?
A: The next steps involve driving adoption of the longitudinal monitoring feature. We are also running additional experiments on EndoCheck, which could potentially enhance OvaWatch with an EndoCheck score. - Nicole Sandford, CEO
Q: What does the droplet PCR platform encompass, and what are the opportunities?
A: We are currently using it for our microRNA. It has advantages in throughput and multivariate analysis. For more scientific details, our scientist Todd Pappas can provide further insights. - Sandra Milligan, President
Q: Can you give more details on the clinical utility study for OvaWatch?
A: The first phase involves gathering data from payers to identify gaps in clinical data needed for policy enhancement. The main objective is to quickly answer these questions and prioritize views from larger payers. - Nicole Sandford, CEO
Q: Can you update us on your ability to boost the balance sheet and visibility into non-dilutive financing?
A: We have made progress in monetizing assets like the biobank and data. We are also applying for various grants and looking for partners to expand our commercial offerings. Our goal is to continue reducing the quarterly burn rate. - Nicole Sandford, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.