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Aspira Women's Health Inc. (AWH)·Q4 2023 Earnings Summary

Executive Summary

  • Q4 2023 was operationally mixed: OvaSuite revenue was $2.1M (flat y/y) as strong OvaWatch growth and higher pricing were offset by lower Ova1Plus volumes; AUP rose to $376 (vs. $369 y/y) on improved reimbursement, while management deliberately accepted near‑term volume softness to complete a commercial refresh .
  • Management guided 2024 cash used in operating activities to $15–$18M and ended 2023 with $2.9M cash (subsequently bolstered by ~$5.5M gross proceeds from a January 2024 offering) .
  • Strategic progress continued: Medicare approved a reimbursement “crosswalk” setting OvaWatch at the Ova1 rate ($897) effective Jan 1, 2024, a clear pricing tailwind; OvaWatch longitudinal monitoring shifted to a Q2 2024 target; endometriosis programs advanced with positive reception and NIH grant pursuit .
  • Key stock catalysts into 2024: execution on OvaWatch longitudinal monitoring, sustained AUP uplift from payer wins, EndoCheck/EndoMDx milestones and potential non‑dilutive funding, plus continued OpEx discipline to extend runway .

What Went Well and What Went Wrong

  • What Went Well

    • Pricing/reimbursement momentum: AUP improved to $376 in Q4 (from $369 y/y), helped by OvaWatch coverage progress; Medicare approved OvaWatch at $897 effective Jan 1, 2024 .
    • Strategic focus and cost discipline: Sales & marketing spend down ~40% y/y in Q4; full‑year cash used in ops reduced ~49% y/y to $15.9M; leadership highlighted “growth, innovation and operational excellence” as the framework for execution .
    • Pipeline traction: OvaWatch longitudinal monitoring manuscripts submitted; endometriosis program (EndoCheck) showcased at SRI with strong clinician interest and NIH grant application underway; “we intend to lead the way in the creation of noninvasive AI‑based tests” .

  • What Went Wrong

    • Growth pause to reset go‑to‑market: Q4 OvaSuite revenue was flat y/y as the company “knew [it] would sacrifice some volume growth in the second half” while eliminating unprofitable territories and rebuilding processes .
    • Mix headwind: Ova1Plus volumes declined, offsetting OvaWatch growth; management is shifting off-label Ova1 usage toward reimbursable OvaWatch, which can depress near‑term volumes even as AUP improves .
    • Capital intensity and going concern risk: Despite major burn reduction, 2024 cash use is still expected at $15–$18M; 10‑K flags substantial doubt about going concern absent additional financing—AWH raised ~$5.5M gross in Jan 2024 and maintains an equity line, but financing risk remains .

Financial Results

MetricQ2 2023Q3 2023Q4 2023
OvaSuite Revenue ($USD Millions)$2.5 $2.2 $2.1
Average Unit Price (AUP, $)$396 $383 $376
Gross Margin %62% 59% —
OvaSuite Tests Performed (Units)6,289 5,783 —
Cash & Equivalents at Period End ($USD Millions)$4.5 $5.4 $2.9 (Dec 31)

Notes: AWH also disclosed a preliminary Q4 cash estimate of ~$2.6M in a Jan 25 8‑K; final year‑end cash was reported as $2.9M on the Mar 28 call .

KPIs and color:

  • Q4 revenue flat y/y as OvaWatch growth and AUP gains were offset by lower Ova1Plus volumes .
  • AUP uplift reflects OvaWatch reimbursement progress; OvaWatch now crosswalked to Ova1 at $897 Medicare rate effective Jan 1, 2024 .
  • Full‑year OvaSuite revenue +15% to $9.2M; full‑year gross margin improved to 57% on lower lab/shipping costs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash used in operating activitiesFY 2024—$15–$18MNew 2024 outlook
OvaWatch LM launch timing2023–2024“By end of 2023” target (Q3 call) Targeting Q2 2024 (10‑K) Delayed to Q2 2024
OvaWatch Medicare reimbursement2023–2024Preliminary crosswalk anticipated (Q3) Crosswalk approved to $897 effective 1/1/2024 Confirmed/implemented
EndoCheck launch planLate 2023Aim to launch by end of 2023 Evaluating best application/timeline; NIH grant pursuit Reassessing timeline

Earnings Call Themes & Trends

TopicQ2 2023 (Prior-2)Q3 2023 (Prior-1)Q4 2023 (Current)Trend
Commercial executionLeaner sales team; S&M -50% y/y; pivot to omnichannel; Q2 AUP $396, GMs 62% Continued S&M reductions; territories turned around; inside sales; Q3 AUP $383, GM 59% “Commercial refresh” largely complete; March showing strength; still filling roles Reset largely complete; building back
Pricing & reimbursementBegan billing OvaWatch under PLA; OvaWatch AUP $326; payer strategy underway CMS prelim crosswalk expected; AUP steady; pursuing payer wins Medicare crosswalk to $897 effective 1/1/24; AUP $376; continued payer progress Positive; pricing tailwind
OvaWatch longitudinal monitoringPreparing manuscript; aim to enable serial use Paper submitted; aim to offer by end of 2023 Manuscripts under review; lab can launch without publication; Q2 2024 target in 10‑K Shifted timing; still a 2024 driver
Endometriosis (EndoCheck/EndoMDx)EndoCheck on track for late‑2023 launch Validation/verification ongoing; staggered rollout plan Strong SRI reception; NIH grant encouraged; evaluating timeline; EndoMDx progressing Clinical interest high; timeline under review
Capital & runwayEquity raise executed; cut burn; 2H’23 burn guidance $6–$8M Cash $5.4M; 2H’23 burn reiterated; LPC equity line in place YE cash $2.9M; Jan 2024 ~$5.5M gross raise; 2024 burn $15–$18M Runway extended; financing still important
Policy/advocacy—Clinical Advisory Board formed (Oct 2023) Biomarker legislation momentum; federal/state interest in women’s health research (ARPA‑H, NIH) Supportive tailwinds emerging

Management Commentary

  • “We have been methodically laying the foundation, brick by brick, for breakout growth… we are ready to reach our full potential” — CEO Nicole Sandford .
  • “OvaSuite revenue for Q4 2023 was $2.1 million… AUP rose to $376” — CFO Torsten Hombeck .
  • “We intend to lead the way in the creation of noninvasive AI-based tests to aid in the diagnosis of gynecologic diseases” — CEO .
  • On reset/near-term softness: “We knew… we would sacrifice some volume growth in the second half of the year by cutting unprofitable territories” — CEO .
  • On EndoCheck momentum: “Our poster at the SRI Conference… was one of the most popular… NIH program managers strongly encouraged a grant application” — CEO .

Q&A Highlights

  • OvaWatch longitudinal monitoring: Manuscripts under review; publication not required to launch; lab director can proceed; development continues toward a Q2 2024 launch target (10‑K) .
  • Pricing/reimbursement: Continued improvement across both Ova1 and OvaWatch; strategy to convert off‑label Ova1 usage to reimbursable OvaWatch; focused team pursuing commercial and Medicaid coverage .
  • Salesforce & territories: 17 FTE sales at YE with inside sales contribution; filling 3 roles; additions tied to reimbursement and strategic relationships .
  • EndoCheck: High clinician interest; NIH grant application imminent; balancing launch with rapid progress on EndoMDx as complementary options .
  • Therapeutic landscape: Existing and emerging endometriosis therapies increase need for non‑invasive diagnostics to accelerate care pathways .

Estimates Context

  • Wall Street consensus (S&P Global) for AWH’s Q4 2023 revenue/EPS was not available in our system; as a result, we cannot provide beat/miss analysis versus consensus at this time. Coverage for micro‑cap diagnostics can be limited (S&P Global data unavailable for this ticker mapping) [functions.GetEstimates error].

Key Takeaways for Investors

  • Pricing tailwind is real: Medicare’s $897 rate for OvaWatch (effective 1/1/24) plus commercial wins should sustain AUP uplift and improve collections as mix shifts to reimbursable tests .
  • 2024 catalysts: OvaWatch longitudinal monitoring launch (Q2 target) and EndoCheck/EndoMDx milestones—both expand TAM and create multiple shots on goal .
  • Execution focus post‑reset: The commercial refresh is largely complete; watch for sequential revenue re‑acceleration as open roles are filled and strategic accounts convert .
  • Cash runway improved but still tight: YE cash $2.9M and Jan 2024 raise (~$5.5M gross) help, yet 2024 cash use guided to $15–$18M; financing risk remains a watch item .
  • Mix matters: Continued substitution of off‑label Ova1 with OvaWatch supports AUP and reimbursement, but can pressure near‑term volumes; sustained payer traction should offset over time .
  • Policy momentum: Growing federal/state support for women’s health and biomarker testing could accelerate adoption and funding (e.g., ARPA‑H, NIH) .

Supporting Documents and Other Relevant Press Releases

  • Q4 2023 earnings call transcript (Mar 28, 2024) –.
  • 8‑K (Jan 25, 2024): financing and preliminary YE 2023 cash (~$2.6M) .
  • FY2023 10‑K (Apr 1, 2024): OvaWatch Medicare crosswalk ($897), OvaWatch LM timing (Q2 2024 target), pipeline details, risk factors .
  • Oct 23, 2023 press release: Clinical Advisory Board established (Q4 2023) –.