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Aspira Women's Health Inc. (AWH)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 revenue was $2.423M (down 3% YoY), with a record 6,471 OvaSuite tests; gross margin was 59% (down 300 bps YoY due to higher shipping costs) .
  • OvaWatch volume rose 48% YoY and 24% sequential; AUP was $374 (up from $369 in Q1, but below $396 in Q2 2023; $381 when adjusted) .
  • Operating cash use was $3.7M (down 16% sequential); management cut full-year operating cash guidance to $13–$14.5M from $15–$18M; balance-of-year cash use guided to $4.8–$6.3M .
  • Post-quarter financings and warrant exercises added $4.0M gross, pro forma cash would have been $5.0M at June 30; new $4.5M ATM facility executed in August .
  • Management highlighted payer wins (Anthem regional plans, Blue Cross additions) and a focus on nondilutive funding (grants, biobank monetization) as key execution catalysts .

What Went Well and What Went Wrong

What Went Well

  • Record quarterly test volume (6,471), with sequential growth and OvaWatch contributing “more than 20%” of volume; OvaWatch volume +24% q/q and +48% y/y .
  • Payer coverage expanded (Anthem plans adding ~8M lives; additional Blue Cross and Medicaid states), and Medicare/Medicare Advantage reimbursement for OvaWatch increased meaningfully in H1 2024 .
  • Management reduced full-year cash use guidance and emphasized nondilutive funding pathways; quote: “Each person in the company sees it as their personal responsibility to continue forward progress while minimizing costs.” — CEO Nicole Sandford .

What Went Wrong

  • Product revenue declined YoY ($2.423M vs $2.491M), and gross margin fell to 59% (from 62%) due to shipping cost increases .
  • AUP fell vs prior year ($374 vs $396; $381 adjusted), indicating pricing headwinds despite sequential improvement .
  • Net loss widened YoY to $(3.530)M; EPS was $(0.28), with higher R&D and S&M reflecting investment in molecular tests and commercial capabilities .

Financial Results

Summary Financials (sequential trend)

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)$2.10 $2.20 $2.423
Gross Margin (%)N/A56.3% 59%
Net Loss ($USD Millions)N/AN/A$(3.530)
EPS (Diluted) ($USD)N/AN/A$(0.28)

Year-over-Year and Sequential Comparisons (Q2 2024 vs Q2 2023 vs Q1 2024)

MetricQ2 2023Q1 2024Q2 2024
Product Revenue ($USD Millions)$2.491 $2.20 $2.423
OvaSuite Tests (Units)6,289 5,829 6,471
AUP ($USD)$396 ($381 adj.) $369 $374
Gross Margin (%)62% 56.3% 59%
Cash Used in Ops ($USD Millions)$3.4 (approx., not disclosed)$4.4 $3.7

Operating Expense Detail (Q2 2024 vs Q2 2023)

Metric ($USD Millions)Q2 2023Q2 2024
Research & Development$0.693 $0.952
Sales & Marketing$1.772 $2.137
General & Administrative$3.406 $2.725
Total Operating Expenses$5.871 $5.814

Balance Sheet and Liquidity

MetricDec 31, 2023Jun 30, 2024Pro Forma Jun 30, 2024
Cash & Cash Equivalents ($USD Millions)$2.597 $0.962 $5.0 (incl. July financings)
Warrant Liabilities ($USD Millions)$1.651 $0.511 N/A
Total Liabilities ($USD Millions)$8.627 $7.670 N/A

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Cash Use ($USD Millions)FY 2024$15–$18 $13–$14.5 Lowered
Operating Cash Use ($USD Millions)Balance of 2024N/A$4.8–$6.3 New disclosure

Earnings Call Themes & Trends

TopicQ4 2023 (Prev-2)Q1 2024 (Prev-1)Q2 2024 (Current)Trend
OvaWatch adoption & longitudinal monitoringPreparing manuscripts; expansion to monitoring in development Two peer-reviewed publications validating monitoring; 114% YoY growth in Q1 Launch of longitudinal monitoring; +24% q/q, +48% y/y volume; >20% of total tests Accelerating adoption
Pricing/AUPAUP improved in 2023; Q4 AUP $376 AUP stable at $369 (mix shift toward OvaWatch) AUP $374; converging OvaWatch with Ova1 pricing; YoY down vs $396 ($381 adj.) Stabilizing sequentially
Gross margin & costFull-year 2023 margin improved to 57% GM 56.3% GM 59%; shipping cost pressure Slight improvement q/q, YoY down
Regulatory (LDT rule)Monitoring FDA LDT rule; no immediate impact expected FDA finalized rule; existing LDTs may be exempt; minimal impact expected Maintain OvaWatch as LDT for now; potential FDA submission later Managed neutrality
Reimbursement coverageOngoing progress; new PLA, CMS crosswalk aiding AUP Anthem CA credentialing; more territories pending Anthem additional regions targeted; Medicaid MD/KY added; Medicare/MA increased Broadening coverage
R&D pipeline (OvaMDx/EndoMDx/EndoCheck)OvaMDx/EndoMDx design and PCR transfer targeted 2024 ARPA-H/NIH grants submitted; EndoCheck traction OvaMDx assay feasibility complete; EndoCheck samples processed; grants pending Advancing milestones
Funding/liquidity$5.5M Jan offering; FY24 cash use guided $15–$18M Equity line access; nondilutive funding pursued Guidance cut to $13–$14.5M; $4.0M July proceeds; $4.5M ATM Improving cash runway focus

Management Commentary

  • “OvaWatch product volume grew an impressive 48%… we expanded the addressable market… to between 2 and 4 million tests per year… ten times the addressable market of the Ova1Plus test.” — CEO Nicole Sandford .
  • “Our in-development molecular tests for ovarian cancer and endometriosis have the potential to be truly ground-breaking… prudent, properly paced R&D spending has not materially impacted our progress.” — President Dr. Sandy Milligan .
  • “Margins this quarter decreased slightly to 59%… due to higher shipping costs… AUP was $374… converging with Ova1.” — CEO Nicole Sandford .
  • “We are updating our guidance for cash used in operations for 2024 to be between $13 million and $14.5 million, down from $15 million to $18 million.” — CEO Nicole Sandford .

Q&A Highlights

  • Adoption drivers: Growth from both new and existing providers; OvaWatch longitudinal monitoring expected to accelerate ramp vs prior product launches .
  • Regulatory stance: Company to keep OvaWatch as LDT for now; may seek FDA clearance later; new LDT regulation not expected to impact current offerings .
  • Payer coverage: Anthem regional contracting adds ~8M lives with further regions targeted; focus on areas with volume to maximize ROI .
  • Nondilutive funding: Biobank monetization (~$500 per sample achieved) and pending grants; aim to further bolster liquidity without dilution .
  • Clinical utility study: Engaging payers to define evidence needs, then structuring a rapid study to broaden coverage .

Estimates Context

  • Wall Street consensus via S&P Global was unavailable due to missing CIQ mapping for AWH in the SPGI dataset; therefore, comparisons to consensus EPS and revenue are not provided [SpgiEstimatesError from GetEstimates].
  • Given sequential revenue growth and lowered cash burn guidance, sell-side models may adjust operating cash assumptions downward and reflect faster OvaWatch adoption momentum; however, without S&P estimates, we cannot quantify revisions .

Key Takeaways for Investors

  • OvaWatch momentum is building with longitudinal monitoring, delivering sequential and YoY growth; focus on payer coverage and protocol inclusion could further accelerate adoption .
  • Pricing and margins are stabilizing sequentially, but YoY AUP and GM pressure highlight the need to rein in shipping costs and sustain reimbursement wins .
  • Liquidity improved post-quarter with $4.0M gross proceeds and a new $4.5M ATM; full-year operating cash use guidance cut to $13–$14.5M supports runway extension without immediate large dilutive financing needs .
  • R&D pipeline (OvaMDx/EndoMDx/EndoCheck) is advancing on assay feasibility and data generation, with grant funding as a potential catalyst for nondilutive support .
  • Near-term trading implications: Potential catalysts include additional Anthem regions, payer protocol inclusion, grant awards, and shipping cost mitigations; risks include pricing/AUP variability and ongoing cash burn .
  • Medium-term thesis: If OvaWatch becomes standard of care for adnexal mass monitoring (2–4M TAM), recurring testing could materially lift revenue visibility; pipeline maturation adds optionality in ovarian cancer and endometriosis diagnostics .

KPIs (Q2 2024 focus)

KPIQ2 2023Q1 2024Q2 2024
OvaSuite Tests (Units)6,289 5,829 6,471
OvaWatch Volume GrowthN/A+114% YoY (Q1 context) +48% YoY; +24% q/q
AUP ($USD)$396 ($381 adj.) $369 $374
Sales Efficiency (Volume per FTE)N/A+22% YoY (Q1) +29% (H1 vs prior year)
Gross Margin (%)62% 56.3% 59%
Cash Used in Operations ($USD Millions)N/A$4.4 $3.7
Ending Cash ($USD Millions)$2.597 (12/31/23) $3.7 incl. restricted (3/31/24) $0.962 (6/30/24); $5.0 pro forma

Note: Estimates from S&P Global were unavailable due to missing CIQ mapping; all results and metrics above are sourced from company filings and transcripts.