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AW

Aspira Women's Health Inc. (AWH)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 OvaSuite revenue was $2.3M (+2% y/y; -4% q/q) on 6,001 tests, with gross margin of 60%; OvaWatch volumes grew 27% y/y despite late-quarter weather disruptions in mature markets .
  • Operating cash use improved to $2.9M (first sub-$3M quarter since Ova1Plus launch); cash ended at $2.1M, and FY24 operating cash utilization guidance was reconfirmed at $13.0–$14.5M .
  • Strategic catalysts advanced: OvaWatch secured NYSDOH CLEP approval (Oct 15), enabling New York access; BioReference distribution expanded to include OvaWatch in NY/NJ (Nov 7), positioning for broader adoption without incremental cost .
  • S&P Global consensus estimates for Q3 2024 were unavailable for AWH; no beat/miss vs consensus can be assessed (S&P mapping missing). This may limit near-term sell-side narrative but does not change fundamental progress on adoption and funding [GetEstimates error: Missing CIQ mapping for AWH].

What Went Well and What Went Wrong

What Went Well

  • OvaWatch adoption momentum: OvaWatch volume +27% y/y; OvaWatch AUP +4% to $360; OvaWatch now 22% of total test volume vs 18% a year ago, illustrating mix shift toward the growth driver .
  • Margin resilience and cash control: Gross margin improved to 60% (from 59% y/y); operating cash use fell to $2.9M, with FY24 cash use guidance reconfirmed at $13.0–$14.5M, signaling execution on cost discipline .
  • Strategic/regulatory tailwinds: NYSDOH approval opened New York; BioReference expansion enables full OvaSuite distribution in NY/NJ; ARPA‑H $10M award supports ENDOinform development and molecular lab build, with the first $2M milestone payment expected by year‑end (management’s expectation) .

Quotes:

  • “OvaWatch product volume... grew an impressive 27%... We have seen continued momentum in the first half of the fourth quarter as well.” — CEO Nicole Sandford .
  • “We were thrilled to be awarded a $10 million ARPA‑H contract... [to] fund the development and commercial launch of ENDOinformSM within the next 24 months.” — CEO Nicole Sandford .
  • “We... submitted the deliverables... [for] the first milestone and... expect to receive the first payment of $2 million before the end of the year.” — President Dr. Sandra Milligan .

What Went Wrong

  • Sequential softness: OvaSuite revenue declined to $2.3M from $2.4M in Q2 (−$0.1M), impacted in part by severe weather at quarter end; overall AUP dipped modestly y/y as OvaWatch’s mix rose (lower AUP than portfolio) .
  • Commercial spend timing: Sales & marketing rose $441K (+26% y/y) in Q3 on field force additions and website launch; while strategic, it weighed on operating loss trajectory in the period .
  • 10‑Q filing delay: Company sought a short 10‑Q filing extension to Nov 19 to finalize accounting for a July 31 warrant inducement; management does not expect a material impact on cash or metrics disclosed in the press release, but the delay can introduce optics risk .

Financial Results

Core P&L and Operating Metrics

MetricQ3 2023Q2 2024Q3 2024
OvaSuite Revenue ($M)$2.2 $2.4 $2.3
OvaSuite Test Volume (Units)5,783 6,471 6,001
Average Unit Price (AUP, $/test)$383 $374 $376
Gross Margin (%)59% 59% 60%
Cash Used in Operating Activities ($M)—$3.7 $2.9
Cash & Cash Equivalents ($M, period-end)—$1.0 $2.1
Diluted EPS ($)—$(0.28) NA (not disclosed in press release; 10‑Q pending)

Notes: Q3 2024 press release provided “selected” results and did not include full GAAP EPS; the 10‑Q was delayed via a short extension .

KPIs and Mix

KPIQ3 2023Q3 2024
OvaWatch Volume Growth (y/y)—+27%
OvaWatch AUP ($)$347 $360
OvaWatch Share of Total Volume (%)18% 22%
Sales Efficiency (Vol per avg FTE; 9M y/y)—+21% (9M vs prior year)

Actuals vs Estimates

MetricActual (Q3 2024)S&P Global ConsensusSurprise
Revenue ($M)$2.3 NA (unavailable)NA
Primary EPS ($)NA (not disclosed) NA (unavailable)NA

Note: S&P Global consensus data unavailable for AWH due to missing mapping; thus, no beat/miss can be determined. Values that would have been retrieved from S&P Global are unavailable.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Cash Utilization ($M)FY 2024$13.0–$14.5 (updated in Q2) $13.0–$14.5 (reconfirmed) Maintained
R&D Expense (directional)Q4 2024—Expected to increase in Q4 (accelerate ENDOinform development with ARPA‑H) Increase (directional)
ARPA‑H Milestone Cash InflowFY 2024—$2.0M expected before year‑end (management expectation) New (timing update)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024, Q2 2024)Current Period (Q3 2024)Trend
OvaWatch adoption & mixQ1: OvaSuite rev $2.2M; vol 5,829 (foundation for growth). Q2: OvaWatch +48% y/y, portfolio TAM expanded via longitudinal monitoring; sales efficiency +29% in 1H .OvaWatch +27% y/y; OvaWatch share 22% (vs 18% LY); OvaWatch AUP +4% .Positive adoption; mix shift to OvaWatch continuing.
Gross marginQ1: 56.3% (improved y/y) . Q2: 59% (shipping costs headwind) .60% (up y/y) .Improving sequentially from Q2 to Q3.
Cash utilization/runwayQ2: FY24 cash use cut to $13–$14.5M; Q2 op cash use $3.7M .Q3 op cash use $2.9M; FY24 guidance reconfirmed .Improving quarterly burn; guidance steady.
Regulatory access (NYSDOH)—OvaWatch CLEP approval in NY (Oct 15) .Regulatory expansion; access to large market.
Distribution leverageCo-marketing with BioReference since 2022 .BioReference expansion to include OvaWatch in NY/NJ (Nov 7) .Strengthened channel for OvaWatch ramp.
Non‑dilutive funding (ARPA‑H)Q2: pursuing non‑dilutive cash; private placement and warrant exercise completed .$10M ARPA‑H award won; first $2M milestone expected before YE; lab build supports ENDOinform and OVAinform efficiency .Major external funding secured; pipeline acceleration.
10‑Q timing/accounting—Short extension to Nov 19 for warrant inducement accounting; no expected material impact on cash or figures disclosed .Administrative timing; limited financial impact per management.
Macro/operational—Severe weather affected end‑of‑quarter demand in mature markets .Transitory exogenous headwind.

Management Commentary

  • Strategy and growth: “We are fully focused on making our OvaSuite test portfolio the universal standard of care for every woman diagnosed with an adnexal mass.” — CEO Nicole Sandford .
  • Funding and pipeline: “We were thrilled to be awarded a $10 million ARPA‑H contract to fund the development and commercial launch of ENDOinformSM within the next 24 months.” — CEO Nicole Sandford .
  • Milestone progress: “We have made substantial progress against the first milestone… and… expect to receive the first payment of $2 million before the end of the year.” — President Dr. Sandra Milligan .
  • Operational cadence: Management noted momentum into early Q4 and highlighted continued sales force productivity improvements over the first nine months .

Q&A Highlights

  • Accounting/filing timing: Management addressed the 10‑Q extension, citing complexity of the July 31 warrant inducement accounting and reiterated the conclusion should not impact reported cash or figures disclosed in the release .
  • ARPA‑H deployment: Management emphasized that ARPA‑H funding supports ENDOinform and broader molecular lab infrastructure, which also benefits OVAinform development and commercialization efficiencies .

Estimates Context

  • S&P Global consensus estimates for AWH Q3 2024 (revenue and EPS) were unavailable due to a missing mapping for the ticker; as a result, beat/miss vs consensus cannot be determined. Investors should note this lack of coverage/mapping can mute near‑term estimate‑revision catalysts but does not affect operational trends [GetEstimates error: Missing CIQ mapping for AWH].

Key Takeaways for Investors

  • Mix shift to OvaWatch is accelerating (volume +27% y/y; share 22%), supporting durable test adoption and pricing power (OvaWatch AUP +4%); watch NY/NJ uptake post‑CLEP approval and BioReference expansion for incremental upside .
  • Margins held at 60% in Q3 and improved q/q; monitor scaling effects, logistics costs, and mix as OvaWatch penetration rises further .
  • Cash burn improved to $2.9M; FY24 operating cash use guided to $13.0–$14.5M; ARPA‑H milestone payment ($2M expected by YE) is a near‑term liquidity catalyst .
  • Regulatory and channel catalysts (NY approval, BioReference expansion) are key to accelerating demand in large markets; track orders and conversion in NY/NJ through Q4 and early 2025 .
  • Pipeline leverage from ARPA‑H builds molecular capabilities for ENDOinform and OVAinform; watch milestone cadence and any early validation or payer progress that could de‑risk commercialization .
  • Short‑term trading implications: potential positive catalysts include NY/NJ ramp data points, ARPA‑H cash receipt, and any early Q4 momentum indicators; an overhang could be the delayed 10‑Q optics (though management does not expect material impact to cash/metrics disclosed) .
  • Medium‑term thesis: execution on channel/regulatory access, sustained sales efficiency gains, and pipeline progress underpinned by non‑dilutive funding can drive a path toward scale, margin expansion, and improved cash dynamics .

Appendix: Other Relevant Press Releases (Q3 context)

  • NYSDOH CLEP approval for OvaWatch (Oct 15, 2024) enabling marketing in New York; validation of test rigor and potential credibility lift in other markets .
  • Expansion of distribution with BioReference to include OvaWatch in NY/NJ (Nov 7, 2024), broadening reach without additional cost burden to Aspira .

Sources:

  • Q3 2024 8‑K (Selected Financial Results/Ex. 99.1) and items therein .
  • Q2 2024 8‑K (Financial Results) .
  • Q1 2024 references (press and transcript summaries) .
  • Q3 2024 earnings call transcript references .
  • Additional Q3‑context press releases .

S&P Global estimates: unavailable for AWH this quarter due to missing mapping; no consensus comparison possible.