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Aspira Women’s Health Reports Second Quarter 2024 Financial Results

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Aspira Women's Health Inc. (Nasdaq: AWH) reported its Q2 2024 financial results. Key highlights include:

- OvaSuiteSM revenue of $2.4 million with 6,471 units sold

- Cash utilization decreased by 16% compared to Q1 2024

- Full year 2024 cash guidance reduced to $13-$14.5 million

- OvaWatch product volume grew 48% year-over-year

- Expanded addressable market to 2-4 million tests per year

- Gross profit margin of 59%

- Raised $4 million through private placement and warrant exercise

- Appointed John Kallassy as interim CFO

The company focuses on developing gynecologic disease diagnostic tools and aims to make OvaSuite the standard of care for adnexal mass diagnosis.

Aspira Women's Health Inc. (Nasdaq: AWH) ha riportato i risultati finanziari del secondo trimestre del 2024. I punti salienti includono:

- Ricavi da OvaSuiteSM di 2,4 milioni di dollari con 6.471 unità vendute

- L'utilizzo di cassa è diminuito del 16% rispetto al primo trimestre del 2024

- Le previsioni di cassa per l'intero anno 2024 sono state ridotte a 13-14,5 milioni di dollari

- Il volume del prodotto OvaWatch è cresciuto del 48% rispetto all'anno precedente

- Mercato indirizzabile ampliato a 2-4 milioni di test all'anno

- Margine di profitto lordo del 59%

- Raccolti 4 milioni di dollari tramite collocamento privato e esercizio di warrant

- Nomina di John Kallassy come CFO ad interim

L'azienda si concentra nello sviluppo di strumenti diagnostici per le malattie ginecologiche e mira a far diventare OvaSuite il trattamento standard per la diagnosi delle masse annessiali.

Aspira Women's Health Inc. (Nasdaq: AWH) reportó sus resultados financieros del segundo trimestre de 2024. Los puntos destacados incluyen:

- Ingresos de OvaSuiteSM de $2.4 millones con 6,471 unidades vendidas

- La utilización de efectivo disminuyó un 16% en comparación con el primer trimestre de 2024

- La guía de efectivo para todo el año 2024 se redujo a $13-$14.5 millones

- El volumen del producto OvaWatch creció un 48% interanual

- Mercado direccionable ampliado a 2-4 millones de pruebas por año

- Margen de utilidad bruta del 59%

- Recaudados $4 millones a través de colocación privada y ejercicio de opciones

- Nombramiento de John Kallassy como CFO interino

La empresa se centra en el desarrollo de herramientas de diagnóstico para enfermedades ginecológicas y tiene como objetivo hacer de OvaSuite el estándar de atención para el diagnóstico de masas anexiales.

Aspira Women's Health Inc. (Nasdaq: AWH)는 2024년 2분기 재무 결과를 발표했습니다. 주요 사항은 다음과 같습니다:

- OvaSuiteSM 수익 240만 달러와 6,471개 판매

- 현금 사용량은 2024년 1분기 대비 16% 감소

- 2024년 전체 연도 현금 가이던스가 1300만~1450만 달러로 축소됨

- OvaWatch 제품의 판매량이 전년 대비 48% 증가

- 연간 대상 시장이 200만~400만 테스트로 확대됨

- 총 이익률 59%

- 사모로 400만 달러 유치 및 워런트 행사

- John Kallassy를 임시 CFO로 임명

회사는 부인과 질병 진단 도구 개발에 집중하며 OvaSuite를 부속종괴 진단의 표준으로 설정하는 것을 목표로 하고 있습니다.

Aspira Women's Health Inc. (Nasdaq: AWH) a annoncé ses résultats financiers pour le deuxième trimestre de 2024. Les points clés incluent :

- Revenus d'OvaSuiteSM de 2,4 millions de dollars avec 6 471 unités vendues

- L'utilisation de liquidités a diminué de 16% par rapport au premier trimestre 2024

- Les prévisions de liquidités pour l'année 2024 ont été réduites à 13-14,5 millions de dollars

- Le volume du produit OvaWatch a augmenté de 48% d'une année sur l'autre

- Marché accessible élargi à 2-4 millions de tests par an

- Marge brute de 59%

- Levée de 4 millions de dollars par le biais d'un placement privé et de l'exercice d'options

- John Kallassy nommé CFO par intérim

L'entreprise se concentre sur le développement d'outils de diagnostic pour les maladies gynécologiques et vise à faire d'OvaSuite le standard de soins pour le diagnostic des masses annexielles.

Aspira Women's Health Inc. (Nasdaq: AWH) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht. Zu den wichtigsten Highlights gehören:

- OvaSuiteSM Einnahmen von 2,4 Millionen Dollar mit 6.471 verkauften Einheiten

- Der Cashverbrauch sank um 16% im Vergleich zum ersten Quartal 2024

- Die Cash-Prognose für das gesamte Jahr 2024 wurde auf 13-14,5 Millionen Dollar gesenkt

- Das Verkaufsvolumen des Produkts OvaWatch wuchs um 48% im Jahresvergleich

- Erweiteter adressierbarer Markt auf 2-4 Millionen Tests pro Jahr

- Bruttogewinnmarge von 59%

- 4 Millionen Dollar durch private Platzierung und Ausübung von Warrants aufgenommen

- John Kallassy als vorläufigen CFO ernannt

Das Unternehmen konzentriert sich auf die Entwicklung von Diagnosewerkzeugen für gynäkologische Erkrankungen und zielt darauf ab, OvaSuite zum Standard für die Diagnose von Adnexveränderungen zu machen.

Positive
  • OvaWatch product volume grew 48% year-over-year
  • Expanded addressable market to 2-4 million tests per year, ten times the Ova1Plus test market
  • Sales efficiency increased 29% for the first six months compared to 2023
  • Cash utilization decreased by 16% compared to Q1 2024
  • Raised $4 million through private placement and warrant exercise
  • Full year 2024 cash guidance reduced to $13-$14.5 million from $15-$18 million
Negative
  • Product revenue decreased to $2.4 million from $2.5 million in Q2 2023
  • Gross profit margin decreased to 59% from 62% in Q2 2023
  • Research and development expenses increased by 37% to $1.0 million
  • Sales and marketing expenses increased by 21% to $2.1 million
  • Cash balance decreased to $1.0 million from $2.9 million at the end of 2023

Insights

Aspira Women's Health's Q2 2024 results show mixed signals. Revenue declined slightly to $2.4 million from $2.5 million in Q2 2023, despite a 3% increase in test volume. The average unit price (AUP) dropped to $374 from $396, indicating pricing pressure. However, sales efficiency improved 29% year-over-year, suggesting better resource utilization.

The company's cash position is concerning, with only $1 million as of June 30, down from $2.9 million at year-end 2023. Recent financing efforts have boosted this to $5 million, but ongoing cash burn remains a challenge. Positively, management has reduced full-year cash utilization guidance to $13-$14.5 million, down from $15-$18 million.

While R&D expenses increased, G&A costs decreased, reflecting a focus on product development while controlling overhead. The expanded addressable market for OvaWatch is promising, but Aspira needs to demonstrate sustained revenue growth and improved cash management to instill investor confidence.

Aspira's focus on expanding its OvaSuite portfolio, particularly the OvaWatch test, is strategically sound. The 48% growth in OvaWatch volume year-over-year is impressive, indicating strong market adoption. The expanded addressable market to 2-4 million tests annually for OvaWatch's longitudinal mass monitoring application is a significant opportunity, potentially 10 times larger than Ova1Plus.

The company's ongoing research in molecular tests for ovarian cancer and endometriosis could be game-changing. The upcoming presentations at major conferences (NPWH and The Menopause Society) suggest continued scientific progress. However, the 37% increase in R&D expenses to $1 million indicates that significant investment is still required to bring these tests to market.

While Aspira's diagnostic tools show promise, the company needs to balance R&D investments with revenue growth to ensure long-term sustainability. The focus on "prudent, properly paced R&D spending" is important given the current financial constraints.

Q2 2024 OvaSuiteSM revenue of $2.4 million and volume of 6,471 units

Q2 2024 cash utilization decreased by 16% compared to Q1 2024

Full year 2024 cash guidance decreased to $13-$14.5 million

Conference Call and Webcast scheduled for today at 4:30 pm ET

AUSTIN, Texas, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today reported its financial results for the second quarter ended June 30, 2024.

“OvaWatch product volume grew an impressive 48% in the second quarter when compared to last year, which we believe is the most important indicator of future growth,” said Nicole Sandford, Chief Executive Officer of Aspira. “We expanded the addressable market of our commercial portfolio to between 2 and 4 million tests per year when we launched the longitudinal mass monitoring application of the OvaWatch test based on powerful new data published in May. This is ten times the addressable market of the Ova1Plus test, which currently enjoys a 5-10% market share. With the hard work of rebuilding the commercial team and tools from the ground up, I believe we are uniquely positioned to take full advantage of the opportunity in front of us. We are now fully focused on making our OvaSuite test portfolio the universal standard of care for every woman diagnosed with an adnexal mass.”

Ms. Sandford added, “We continue to aggressively pursue nondilutive sources of cash. However, our recent financing brought in the cash we needed to stay focused on our goals based on our lower cash projections for the year. Each person in the company sees it as their personal responsibility to continue forward progress while minimizing costs.”

Dr. Sandy Milligan, President of Aspira said, “Our in-development molecular tests for ovarian cancer and endometriosis have the potential to be truly ground-breaking for women’s health. Our focus on prudent, properly paced R&D spending has not materially impacted our progress towards our near-term milestones. I am excited to continue leading the design and development of cutting-edge diagnostic tools for gynecologic diseases that have plagued women for far too long.”

Recent Corporate Highlights

  • Announced its poster entitled: “Association of the Endometriosis Health Profile-5 (EHP-5) with Non-invasive Biomarkers in Patients with Suspected Endometriosis,” will be presented on September 26 and 27th at the 27th Annual National Association of Nurse Practitioners in Women’s Health (NPWH) Women’s Healthcare Conference being held in Chicago, IL.
  • Announced its poster entitled “Application of Deep Neural Network-Based Algorithm to Provide Additional Information in the Assessment of Adnexal Masses Classified as Indeterminate by Imaging” will be presented on September 12, 2024, at The Menopause Society’s 2024 Annual Meeting being held in Chicago, Il.
  • Appointed Mr. John Ragard to its Board of Directors. Mr. Ragard is an accomplished executive with extensive experience successfully managing several billion-dollar portfolios over his career.
  • Closed private placement for the issuance and sale of shares of the Company’s common stock and accompanying warrants to purchase an equal number of shares for gross proceeds of $1.9 million in July 2024.
  • Completed a warrant exercise transaction with gross proceeds of $2.1 million in July 2024.
  • Announced the appointment of John Kallassy as interim chief financial officer, effective August 15, 2024.

Second Quarter 2024 Financial Highlights

  • Product revenue for the three months ended June 30, 2024, was $2.4 million compared to $2.5 million for the same period in 2023. The number of OvaSuite tests performed was approximately 6,471 during the three months ended June 30, 2024, a 3% increase compared to the approximately 6,289 OvaSuite tests for the same period in 2023. The average unit price (AUP) for the Company’s OvaSuite tests was $374 for the three months ended June 30, 2024, compared to $396 for the same period in 2023 ($381 when adjusted for a change in estimate). Sales efficiency, as measured by volume per average full-time sales representative, increased 29% for the first six months of the year when compared to the same period of 2023.
  Field Sales Rep
Ending Quantity
 
 2024 Q2 17 
 2024 Q1 13 
 2023 Q4 15 
 2023 Q3 16 
 2023 Q2 18 
 2023 Q1 18 
 2022 Q4 24 
 2022 Q3 32 
 2022 Q2 27 
 2022 Q1 26 
    
  • Gross profit margin for the three months ended June 30, 2024, was 59% compared to 62% for the same period in 2023. Gross profit was impacted by an increase in shipping costs this quarter.
  • Research and development expenses for the three months ended June 30, 2024, were $1.0 million, an increase of 37%, compared to $0.7 million for the same period in 2023. This increase was primarily due to an increase in collaboration costs for the Company’s molecular test product development program offset by a decrease in personnel costs.
  • Sales and marketing expenses for the three months ended June 30, 2024, were $2.1 million, an increase of 21%, compared to $1.8 million for the same period in 2023. The increase was primarily due to an increase in personnel costs for strategic account leaders, marketing, and inside sales.
  • General and administrative expenses for the three months ended June 30, 2024, were $2.7 million, a decrease of 20%, compared to $3.4 million for the same period in 2023. This decrease was primarily due to a decrease in personnel and consulting costs.

Balance Sheet Highlights
As of June 30, 2024, Aspira had $1.0 million in cash, compared to $2.9 million in cash as of December 31, 2023. Subsequent to the end of the quarter, Aspira raised $1.9 million in gross proceeds in a registered direct offering and $2.1 million in a warrant inducement offering. Adjusting for this, the cash balance as of June 30, 2024, would have been $5.0 million. Additionally, the Company entered into a $4.5 million at-the-market facility with H.C. Wainwright.

Cash used in operating activities was $3.7 million for the three months ended June 30, 2024. The Company is updating its expected operating cash utilization target for the balance of 2024 to be between $4.8 million and $6.3 million, or $13 million and $14.5 million for the full year 2024, down from its original 2024 target of between $15 million and $18 million.

Conference Call and Webcast Details
Aspira’s management team will host a conference call beginning at 4:30 pm ET today, August 12, 2024. Investors and other interested parties may participate in the conference call by dialing 1-877-407-4018. The call will be available via webcast by clicking HERE or on the events page of the Company’s website after the conclusion of the call.

About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.

OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is comprised of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in women planned for surgery.

Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDxSM risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDxSM test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis. 

Forward-Looking Statements
This press release may contain forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including those relating to the timing and completion of any products in the pipeline development and other statement that are predictive in nature. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “risk factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact: 
Nicole Sandford
Chief Executive Officer
Investors@aspirawh.com

++++Tables to Follow ++++

 
Aspira Women’s Health Inc.
Condensed Consolidated Balance Sheets (unaudited)
(Amounts in Thousands, Except Share and Par Value Amounts)
       
  June 30, December 31,
  2024
 2023
Assets (Unaudited)   
Current assets:      
Cash and cash equivalents $962  $2,597 
Accounts receivable, net of reserves of $0 and $15, as of June 30, 2024 and December 31, 2023, respectively  1,445   1,459 
Prepaid expenses and other current assets  618   997 
Inventories  226   227 
Total current assets  3,251   5,280 
Property and equipment, net  120   165 
Right-of-use assets  559   528 
Restricted cash  -   258 
Other assets  31   31 
Total assets $3,961  $6,262 
Liabilities and Stockholders’ Deficit      
Current liabilities:      
Accounts payable $1,943  $1,261 
Accrued liabilities  2,856   2,863 
Current portion of long-term debt  316   166 
Short-term debt  166   670 
Current maturities of lease liabilities  177   159 
Total current liabilities  5,458   5,119 
Non-current liabilities:      
Long-term debt  1,264   1,430 
Non-current maturities of lease liabilities  437   427 
Warrant liabilities  511   1,651 
Total liabilities  7,670   8,627 
Commitments and contingencies      
Stockholders’ deficit:      
Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at June 30, 2024 and December 31, 2023, respectively; 12,825,090 and 10,645,049 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively  13   11 
Additional paid-in capital  522,740   515,927 
Accumulated deficit  (526,462)  (518,303)
Total stockholders’ deficit  (3,709)  (2,365)
Total liabilities and stockholders’ deficit $3,961  $6,262 


Aspira Women’s Health Inc.
Condensed Consolidated Statements of Operations (unaudited)
(Amounts in Thousands, Except Share and Per Share Amounts)
             
  Three Months Ended Six Months Ended
  June 30, June 30,
  2024
 2023
 2024
 2023
Revenue:            
Product $2,423  $2,491  $4,576  $4,806 
Genetics  -   -   -   1 
Total revenue  2,423   2,491   4,576   4,807 
Cost of revenue:            
Product  1,002   941   1,941   2,071 
Total cost of revenue  1,002   941   1,941   2,071 
Gross profit  1,421   1,550   2,635   2,736 
Operating expenses:            
Research and development  952   693   1,858   1,960 
Sales and marketing  2,137   1,772   4,026   4,367 
General and administrative  2,725   3,406   5,854   7,010 
Total operating expenses  5,814   5,871   11,738   13,337 
Loss from operations  (4,393)  (4,321)  (9,103)  (10,601)
Other income (expense), net:            
Change in fair value of warrant liabilities  889   992   1,140   968 
Interest (expense) income, net  (10)  8   (15)  34 
Forgiveness of DECD loan  -   1,000   -   1,000 
Other expense, net  (16)  4   (181)  (296)
Total other income (expense), net  863   2,004   944   1,706 
Net loss $(3,530) $(2,317) $(8,159) $(8,895)
Net loss per share - basic and diluted $(0.28) $(0.28) $(0.67) $(1.06)
Weighted average common shares used to compute basic and diluted net loss per common share  12,518,725   8,400,157   12,181,481   8,357,013 

FAQ

What was Aspira Women's Health (AWH) OvaSuiteSM revenue in Q2 2024?

Aspira Women's Health reported OvaSuiteSM revenue of $2.4 million in Q2 2024.

How many OvaSuite tests did Aspira Women's Health (AWH) perform in Q2 2024?

Aspira Women's Health performed approximately 6,471 OvaSuite tests during Q2 2024, a 3% increase compared to the same period in 2023.

What was the average unit price (AUP) for Aspira Women's Health (AWH) OvaSuite tests in Q2 2024?

The average unit price (AUP) for Aspira Women's Health OvaSuite tests was $374 in Q2 2024, compared to $396 for the same period in 2023.

How much did Aspira Women's Health (AWH) raise in financing in July 2024?

Aspira Women's Health raised a total of $4 million in July 2024, with $1.9 million from a private placement and $2.1 million from a warrant exercise transaction.

What is Aspira Women's Health (AWH) updated cash guidance for full year 2024?

Aspira Women's Health updated its full year 2024 cash guidance to $13-$14.5 million, down from the original target of $15-$18 million.

Aspira Women's Health Inc.

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In Vitro & in Vivo Diagnostic Substances
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