STOCK TITAN

OraSure Reports Fourth Quarter 2024 Financial Results

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags

OraSure Technologies (NASDAQ: OSUR) reported Q4 2024 financial results showing total net revenues decreased 51% to $37.4 million from $75.9 million in Q4 2023, primarily due to declining COVID-19 revenues. Core revenues increased 10% year-over-year to $36.5 million, with Diagnostics revenues up 9% to $18.8 million and Sample Management Solutions up 14% to $14.8 million.

The company reported a GAAP operating loss of $12.4 million compared to operating income of $3.9 million in Q4 2023. Cash and cash equivalents stood at $267.8 million. Notable developments include the acquisition of Sherlock Biosciences to expand molecular diagnostics capabilities, FDA approval for expanded age range of OraQuick HIV Self-Test, and a $7.5 million BARDA contract for Marburg Virus Disease test development. The company guides Q1 2025 revenues between $27.5-31.5 million.

OraSure Technologies (NASDAQ: OSUR) ha riportato i risultati finanziari del Q4 2024, mostrando che i ricavi netti totali sono diminuiti del 51% a $37.4 milioni rispetto ai $75.9 milioni del Q4 2023, principalmente a causa della diminuzione dei ricavi legati al COVID-19. I ricavi core sono aumentati del 10% rispetto all'anno precedente, raggiungendo i $36.5 milioni, con i ricavi da Diagnostica in aumento del 9% a $18.8 milioni e le Soluzioni di Gestione dei Campioni in crescita del 14% a $14.8 milioni.

La società ha riportato una perdita operativa GAAP di $12.4 milioni rispetto a un utile operativo di $3.9 milioni nel Q4 2023. Le disponibilità liquide e equivalenti ammontano a $267.8 milioni. Tra gli sviluppi significativi ci sono l'acquisizione di Sherlock Biosciences per espandere le capacità di diagnostica molecolare, l'approvazione della FDA per l'ampliamento della fascia di età dell'OraQuick HIV Self-Test e un contratto BARDA di $7.5 milioni per lo sviluppo di test per la malattia da virus Marburg. L'azienda prevede ricavi per il Q1 2025 compresi tra $27.5 e $31.5 milioni.

OraSure Technologies (NASDAQ: OSUR) informó los resultados financieros del Q4 2024, mostrando que los ingresos netos totales disminuyeron un 51% a $37.4 millones desde $75.9 millones en el Q4 2023, principalmente debido a la disminución de los ingresos por COVID-19. Los ingresos principales aumentaron un 10% interanual a $36.5 millones, con ingresos por Diagnósticos en aumento del 9% a $18.8 millones y Soluciones de Gestión de Muestras en aumento del 14% a $14.8 millones.

La compañía reportó una pérdida operativa GAAP de $12.4 millones en comparación con un ingreso operativo de $3.9 millones en el Q4 2023. El efectivo y equivalentes de efectivo se situaron en $267.8 millones. Entre los desarrollos notables se incluyen la adquisición de Sherlock Biosciences para expandir las capacidades de diagnóstico molecular, la aprobación de la FDA para ampliar el rango de edad de la prueba de autoevaluación de VIH OraQuick, y un contrato de BARDA de $7.5 millones para el desarrollo de pruebas para la enfermedad del virus Marburg. La compañía prevé ingresos para el Q1 2025 entre $27.5 y $31.5 millones.

오라세어 테크놀로지스 (NASDAQ: OSUR)는 2024년 4분기 재무 결과를 발표하며 총 순수익이 2023년 4분기 7590만 달러에서 3740만 달러로 51% 감소했다고 보고했습니다. 이는 주로 COVID-19 관련 수익 감소 때문입니다. 핵심 수익은 전년 대비 10% 증가하여 3650만 달러에 달했으며, 진단 수익은 9% 증가하여 1880만 달러, 샘플 관리 솔루션은 14% 증가하여 1480만 달러에 도달했습니다.

회사는 GAAP 기준 운영 손실이 1240만 달러로, 2023년 4분기 운영 수익 390만 달러와 비교되었습니다. 현금 및 현금성 자산은 2억 6780만 달러에 달했습니다. 주요 개발 사항으로는 분자 진단 능력을 확장하기 위한 셔록 바이오사이언스 인수, OraQuick HIV 자가 검사의 연령대 확대에 대한 FDA 승인, 마르부르크 바이러스 질병 테스트 개발을 위한 750만 달러 BARDA 계약이 포함됩니다. 회사는 2025년 1분기 수익을 2750만 달러에서 3150만 달러 사이로 안내하고 있습니다.

OraSure Technologies (NASDAQ: OSUR) a annoncé les résultats financiers du 4e trimestre 2024, montrant que les revenus nets totaux ont diminué de 51 % pour atteindre 37,4 millions de dollars, contre 75,9 millions de dollars au 4e trimestre 2023, principalement en raison de la baisse des revenus liés au COVID-19. Les revenus principaux ont augmenté de 10 % par rapport à l'année précédente, atteignant 36,5 millions de dollars, avec des revenus de diagnostic en hausse de 9 % à 18,8 millions de dollars et des solutions de gestion d'échantillons en hausse de 14 % à 14,8 millions de dollars.

L'entreprise a enregistré une perte d'exploitation GAAP de 12,4 millions de dollars, contre un bénéfice d'exploitation de 3,9 millions de dollars au 4e trimestre 2023. Les liquidités et équivalents de liquidités s'élevaient à 267,8 millions de dollars. Parmi les développements notables figurent l'acquisition de Sherlock Biosciences pour étendre les capacités de diagnostic moléculaire, l'approbation de la FDA pour élargir la tranche d'âge du test de dépistage du VIH OraQuick, et un contrat BARDA de 7,5 millions de dollars pour le développement de tests pour la maladie à virus Marburg. L'entreprise prévoit des revenus pour le 1er trimestre 2025 compris entre 27,5 et 31,5 millions de dollars.

OraSure Technologies (NASDAQ: OSUR) berichtete über die finanziellen Ergebnisse für das 4. Quartal 2024 und zeigte, dass die gesamten Nettoumsätze um 51% auf 37,4 Millionen Dollar im Vergleich zu 75,9 Millionen Dollar im 4. Quartal 2023 gesunken sind, hauptsächlich aufgrund rückläufiger COVID-19-Einnahmen. Kernumsätze stiegen im Jahresvergleich um 10% auf 36,5 Millionen Dollar, wobei die Diagnostikeinnahmen um 9% auf 18,8 Millionen Dollar und die Lösungen für das Probenmanagement um 14% auf 14,8 Millionen Dollar zunahmen.

Das Unternehmen meldete einen GAAP-Betriebsverlust von 12,4 Millionen Dollar im Vergleich zu einem Betriebsgewinn von 3,9 Millionen Dollar im 4. Quartal 2023. Die liquiden Mittel und Zahlungsmitteläquivalente beliefen sich auf 267,8 Millionen Dollar. Zu den bemerkenswerten Entwicklungen gehören die Übernahme von Sherlock Biosciences zur Erweiterung der molekularen Diagnostikfähigkeiten, die FDA-Zulassung für die erweiterte Altersgruppe des OraQuick HIV-Selbsttests und ein BARDA-Vertrag über 7,5 Millionen Dollar zur Entwicklung von Tests für die Marburg-Virus-Krankheit. Das Unternehmen prognostiziert für das 1. Quartal 2025 Umsätze zwischen 27,5 und 31,5 Millionen Dollar.

Positive
  • Strong cash position of $267.8 million
  • Core revenue growth of 10% year-over-year
  • Sample Management Solutions revenue up 14%
  • Diagnostics revenue increased 9%
  • $7.5M BARDA contract awarded for Marburg virus test development
Negative
  • 51% decline in total net revenues to $37.4M
  • GAAP operating loss of $12.4M vs income of $3.9M in Q4 2023
  • Gross margin declined to 36.2% from 46.3% year-over-year
  • 98% decrease in COVID-19 revenues
  • Expected Q1 2025 revenue guidance shows sequential decline

Insights

OraSure Technologies' Q4 2024 results reveal a company in strategic transition, with total revenue declining 51% to $37.4 million year-over-year due to the expected wind-down of COVID-19 testing. However, the 10% growth in core revenues to $36.5 million demonstrates the underlying strength of the company's fundamental business segments, with Diagnostics and Sample Management growing at 9% and 14% respectively.

The company's profitability metrics reflect this transition period, with gross margins contracting from 46.3% to 36.2% and a shift from operating income to a $12.4 million operating loss. This margin compression stems from both the loss of high-margin COVID revenue and an increasing proportion of international sales, which typically carry lower margins.

What's particularly notable is OraSure's cash position of $267.8 million, representing approximately 92% of the company's current market capitalization. This substantial cash reserve not only provides significant downside protection but also enables strategic investments during this transition phase. The December acquisition of Sherlock Biosciences for $5 million represents a pivotal strategic move, providing OraSure with an advanced molecular diagnostics platform that could substantially expand their addressable market.

The Sherlock acquisition signals a clear strategic pivot toward higher-value molecular diagnostics, with their first product targeting Chlamydia and Gonorrhea expected for FDA submission by end of 2025. This platform's potential for over-the-counter molecular testing represents a significant market opportunity, as it would bring lab-quality results directly to consumers without the need for specialized equipment or professional oversight.

Additional growth catalysts include the expanded FDA labeling for their HIV Self-Test to include adolescents 14 and older, potentially increasing market penetration in a critical demographic. The $7.5 million government contract (expandable to $11 million) for Marburg Virus testing development further diversifies their revenue streams while leveraging their core competencies in rapid diagnostics.

The Q1 2025 revenue guidance of $27.5-31.5 million suggests a sequential decline from Q4, though this may reflect typical seasonality patterns. The planned exit from Risk Assessment testing by mid-2025 represents another strategic streamlining to focus resources on higher-growth opportunities.

OraSure appears to be methodically repositioning itself from a COVID-beneficiary to a focused diagnostics innovator with multiple growth vectors. The market's current valuation, with the stock trading near cash value, suggests investors may be underappreciating both the stability of the core business and the potential of their strategic initiatives in molecular diagnostics.

BETHLEHEM, Pa., Feb. 25, 2025 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended December 31, 2024.

“Our Q4 revenue was consistent with our expectations, including 10% growth in our core revenue. We continue to see signs of gradual recovery in our key end markets, and we are diversifying our business by expanding our product portfolio and adding new customers, offset by elevated uncertainty for some of our existing customers related to government funding sources,” said OraSure President and CEO Carrie Eglinton Manner. “We made tremendous progress in our strategic transformation in 2024, which gives us confidence that OTI is positioned to deliver growth in our core business and drive further productivity gains.”

She added, “Our strong balance sheet has allowed us to significantly advance our innovation strategy, including the acquisition of Sherlock Biosciences, which brings to our pipeline an advanced molecular platform that we expect will expand access to diagnostic insights through convenient, effortless tests. Overall, we continue to progress operationally to leverage our differentiated products and our strong customer relationships to drive profitable long-term growth and create shareholder value.”

Financial Highlights

 For the Three Months Ended December 31, For the Years Ended December 31,
  2024  2023 % Change  2024  2023 % Change
Core Business (1)$36,482 $33,310 10% $138,950 $143,219 (3)%
Molecular Services 13  907 (99)  1,705  4,474 (62)
COVID-19 950  41,664 (98)  45,172  257,779 (82)
Total Net Revenues$37,445 $75,881 (51)% $185,827 $405,472 (54)%
                

(1) Includes Diagnostics, Sample Management Solutions, Risk Assessment Testing, other products and services revenues, and non-product and services revenues.

 For the Three Months Ended December 31, For the Years Ended December 31,
  2024   2023  % Change  2024   2023  % Change
Net revenues$37,445  $75,881  (51)% $185,827  $405,472  (54)%
Gross profit 13,566   35,126  (61)  79,390   171,652  (54)
Gross margin 36.2%  46.3%    42.7%  42.3%  
Non-GAAP gross profit 15,000   35,264  (57)  82,490   173,262  (52)
Non-GAAP gross margin 40.1%  46.5%    44.4%  42.7%  
            
Operating income (loss) (12,418)  3,898  NM   (28,250)  32,684  NM 
Operating margin(33.2)%  5.1%    (15.2)%  8.1%   
Non-GAAP operating income (loss) (6,745)  11,151  NM   (6,422)  62,350  NM 
Non-GAAP operating margin(18.0)%  14.7%    (3.5)%  15.4%   
              
Net income (loss) (10,794)  20,073  NM   (19,500)  53,655  NM 
Non-GAAP net income (loss) (4,230)  13,521  NM   3,943   66,311  (94)
Diluted GAAP EPS$(0.14) $0.27  NM  $(0.26) $0.72  NM 
Diluted Non-GAAP EPS$(0.06) $0.18  NM  $0.05  $0.89  (94)

NM – not meaningful

  • Total net revenues for the fourth quarter of 2024 decreased 51% to $37.4 million from $75.9 million in the fourth quarter of 2023 primarily due to the decline in COVID-19 revenues.
  • Core revenues (all revenues excluding COVID-19 and Molecular Services revenues) of $36.5 million in the fourth quarter increased 10% year-over-year. Diagnostics revenues in the fourth quarter increased 9% year-over-year to $18.8 million and Sample Management Solutions revenues increased 14% to $14.8 million.
  • COVID-19 revenues of $1.0 million in the fourth quarter decreased 98% year-over-year primarily due to the completion of our largest government contract earlier in 2024.
  • GAAP gross margin was 36.2% in the fourth quarter of 2024 compared to 46.3% in the fourth quarter of 2023. Non-GAAP gross margin in the fourth quarter of 2024 was 40.1% compared to 46.5% in the fourth quarter of 20231. On a year-over-year basis, gross margin was impacted by the decline in COVID-19 revenues and the higher mix of international revenues.
  • GAAP operating loss in the fourth quarter of 2024 was $12.4 million compared to operating income of $3.9 million in the fourth quarter of 2023. Non-GAAP operating loss was $6.7 million in the fourth quarter of 2024 compared to non-GAAP operating income of $11.2 million in the fourth quarter of 2023.
  • Cash and cash equivalents were $267.8 million as of December 31, 2024. Cash flow from operations in the fourth quarter of 2024 was $0.1 million. During the fourth quarter, we deployed $5.0 million for the acquisition of Sherlock Biosciences.

1 For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules.

Recent Business Developments

  • OTI acquired Sherlock Biosciences in December to expand our innovation pipeline with the addition of a molecular diagnostics platform that, subject to approval by the U.S. Food and Drug Administration (FDA), is expected to provide rapid results with strong sensitivity and specificity in a disposable format that will be well-suited for over-the-counter usage. Sherlock’s first molecular self-test, for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), is in clinical trials and is expected to be submitted to the FDA by the end of 2025 for review.
  • Received FDA approval for a labeling change to the OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents. The change expands the approved age range for the OraQuick® HIV Self-Test to include individuals 14 years of age and older. Previously the test was approved for use in those 17 and older.
  • Received an award through the Rapid Response Partnership Vehicle (RRPV) for the development of a Marburg Virus Disease (MVD) rapid antigen test. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The initial contract award, valued at approximately $7.5 million over multiple years in the base period with potential value up to $11 million, funds the development to achieve FDA 510(k) clearance of a single-use lateral flow immunoassay intended for the qualitative detection of antigens from viruses within the Marburg virus genus.
  • Made significant progress in exiting our Risk Assessment testing business. We plan to continue to support our Risk Assessment customers and wind down remaining inventory during the first half of 2025.

Financial Guidance

The Company is guiding to Q1 2025 revenues of $27.5 million to $31.5 million. The Company anticipates Core revenues in Q1 2025 of $27 million to $31 million, which includes approximately $1 million of Risk Assessment testing revenues. The Company anticipates COVID-19 revenues in Q1 2025 of approximately $0.5 million.

Conference Call

The Company will host a conference call and audio webcast to discuss the Company’s fourth quarter 2024 results and certain business developments, beginning today at 5 p.m. Eastern Time. The call will include prepared remarks by management and a question and answer session.

A webcast of the conference call will be available on the investor relations page of OTI’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OTI’s website shortly after the call has ended and will be available for approximately 90 days. If a participant will be listen-only, they are encouraged to listen via the webcast.

For participants interested in asking a question during the conference call, please follow the link below to pre-register. After registering, you will be provided with your access details via email. It is recommended to dial in at least 15 minutes prior to the call start time.

https://register.vevent.com/register/BI400ff7eb0f2149dfa53af33625f6bdfb 

OTI intends to use the Investor Relations Section of its website as a means of disclosing material non-public information (MNPI) and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor OTI’s website in addition to following its press releases, SEC filings, public conference calls, presentations, and webcasts.

Financial Data (Unaudited)

 For the Three Months Ended December 31, For the Years Ended December 31,
  2024   2023  2024   2023 
Results of Operations       
Net revenues$37,445  $75,881 $185,827  $405,472 
Cost of products and services sold 23,879   40,755  106,437   233,820 
Gross profit 13,566   35,126  79,390   171,652 
Operating expenses:       
Research and development 6,087   6,991  26,047   33,728 
Sales and marketing 6,992   6,906  30,986   36,319 
General and administrative 12,905   14,005  46,215   58,191 
Loss on impairments    3,326  4,392   10,829 
Change in the estimated fair value of acquisition-related contingent consideration         (99)
Total operating expenses 25,984   31,228  107,640   138,968 
Operating income (loss) (12,418)  3,898  (28,250)  32,684 
Other income 2,911   16,822  12,249   23,574 
Income (loss) before income taxes (9,507)  20,720  (16,001)  56,258 
Income tax expense 758   647  1,799   2,603 
Loss on equity investment (529)    (1,700)   
Net income (loss)$(10,794) $20,073 $(19,500) $53,655 
Income (loss) per share:       
Basic$(0.14) $0.27 $(0.26) $0.73 
Diluted$(0.14) $0.27 $(0.26) $0.72 
Weighted average shares outstanding:       
Basic 74,597   73,499  74,434   73,348 
Diluted 74,597   75,013  74,434   74,389 
               


 For the Three Months Ended December 31, For the Years Ended December 31,
  2024  2023 % Change  2024  2023 % Change
Consolidated Net Revenues           
Diagnostics$18,768 $17,219 9% $75,917 $73,694 3%
Sample Management Solutions 14,809  13,044 14   51,046  54,274 (6)
COVID-19 Diagnostics 950  41,617 (98)  45,136  257,493 (82)
Risk Assessment Testing 2,055  2,196 (6)  8,354  9,736 (14)
Other products and services 636  526 21   2,417  2,265 7 
Molecular Services 13  907 (99)  1,705  4,474 (62)
COVID-19 Molecular Products   47 (100)  36  286 (87)
Net product and services revenues 37,231  75,556 (51)  184,611  402,222 (54)
Non-product and services revenues 214  325 (34)  1,216  3,250 (63)
Net revenues$37,445 $75,881 (51)% $185,827 $405,472 (54)%
                

Condensed Consolidated Balance Sheets (Unaudited)

 December 31, 2024 December 31, 2023
Assets   
Cash and cash equivalents$267,763 $290,407
Accounts receivable, net 23,816  40,171
Inventories 34,197  47,614
Other current assets 7,444  8,267
Property, plant and equipment, net 45,105  45,420
Intangible assets, net 17,134  1,206
Goodwill 41,831  35,696
Investment in equity method investee 28,300  
Other noncurrent assets 15,269  14,064
Total assets$480,859 $482,845
    
Liabilities and Stockholders’ Equity   
Accounts payable$8,173 $13,151
Deferred revenue 2,961  1,559
Other current liabilities 22,349  24,826
Other noncurrent liabilities 37,038  12,638
Stockholders’ equity 410,338  430,671
Total liabilities and stockholders’ equity$480,859 $482,845
      

Additional Financial Data (Unaudited)

 For the Years Ended December 31,
  2024  2023
Capital expenditures$3,797 $10,303
Proceeds from funding under government contract (1)   48,669
Depreciation and amortization 10,872  20,936
Stock-based compensation 11,920  10,729
Cash provided by operating activities$27,374 $141,583

(1) Proceeds represent reimbursement for capital expenditures, engineering consulting costs, and guaranteed profit to cover project management costs.

Consolidated Statement of Cash Flows (Unaudited)

 For the Years Ended December 31,
  2024   2023 
OPERATING ACTIVITIES:   
Net (loss) income$(19,500) $53,655 
Adjustments to reconcile net (loss) income to net cash provided by operating activities:   
Stock-based compensation 11,920   10,729 
Depreciation and amortization 10,872   20,936 
Loss on impairments 4,392   10,829 
Other non-cash amortization (564)  3 
Provision for credit losses 71   (462)
Unrealized foreign currency gain (263)  103 
Interest expense on finance leases 22   51 
Loss on equity investment 1,700    
Deferred income taxes (657)  102 
Loss on sale of fixed assets 563    
Change in the estimated fair value of acquisition-related contingent consideration    (99)
Payment of acquisition-related contingent consideration    (19)
Changes in assets and liabilities:   
Accounts receivable 15,872   31,116 
Inventories 13,096   48,228 
Prepaid expenses and other assets 4,089   (2,499)
Accounts payable (7,577)  (26,976)
Deferred revenue (219)  (730)
Accrued expenses and other liabilities (6,443)  (3,384)
Net cash provided by operating activities 27,374   141,583 
INVESTING ACTIVITIES:   
Purchases of short-term investments (53,244)  (74,652)
Investment in equity method investee (30,000)   
Proceeds from maturities and redemptions of short-term investments 53,052   102,440 
Purchases of property and equipment (3,797)  (5,802)
Acquisition of business, net of cash acquired (5,037)   
Purchase of property and equipment under government contracts    (4,501)
Proceeds from funding under government contract (1)    48,669 
Net cash (used in) provided by investing activities (39,026)  66,154 
FINANCING ACTIVITIES:   
Cash payments for lease liabilities (842)  (1,345)
Proceeds from exercise of stock options 214   269 
Payment of acquisition-related contingent consideration    (46)
Repurchase of common stock (3,548)  (1,901)
Net cash used in financing activities (4,176)  (3,023)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH (6,816)  1,713 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (22,644)  206,427 
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 290,407   83,980 
CASH AND CASH EQUIVALENTS, END OF PERIOD$267,763  $290,407 
        

About OraSure Technologies

OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. OraSure, together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

About Marburg Virus Disease (MVD) rapid antigen test

The Marburg Virus Disease (MVD) rapid antigen test project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005, and the Project Identifier is RRPV-24-06-DxR2-007 (OraSure).

Forward Looking Statements

This press release contains certain forward-looking statements, including with respect to products, product candidate development and manufacturing activities, regulatory submissions and authorizations, revenue growth and guidance, expected revenue from government orders, cost savings, cash flow, increasing margins and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; the demand for our COVID-19 testing products; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of replacing distributors; inventory levels at distributors and other customers; our ability to achieve its financial and strategic objectives and increase our revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of our products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to achieve and maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity breaches or other attacks involving our systems or those of our third-party contractors and IT service providers, suppliers and customers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including inflationary pressures, the imposition of tariffs and banking stability. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Statement Regarding Use of Non-GAAP Financial Measures

In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures, including non-GAAP gross margin, non-GAAP gross profit, non-GAAP net income (loss), non-GAAP operating income (loss), and non-GAAP earnings (loss) per share. Management believes that presentation of operating results using these non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods, while excluding certain expenses that may not be indicative of the Company’s recurring core business operating results. In addition, management believes these non-GAAP financial measures are useful to investors both because they (1) allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) are used by OraSure’s institutional investors and the analysis community to help them analyze the health of OraSure’s business. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of the schedules.

The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.

OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's)

 For the Three Months Ended December 31, For the Years Ended December 31,
  2024   2023   2024   2023 
Revenue$37,445  $75,881  $185,827  $405,472 
GAAP Cost of products and services sold 23,879   40,755   106,437   233,820 
GAAP Gross Margin 36.2%  46.3%  42.7%  42.3%
Stock compensation 195   138   734   564 
Amortization of acquisition-related intangible assets          396 
Reduction in workforce severance 239      1,366   369 
Transformation related expenses          281 
Inventory reserve for product line discontinuance 1,000      1,000    
Non-GAAP Cost of Goods Sold 22,445   40,617   103,337   232,210 
Non-GAAP Gross Margin 40.1%  46.5%  44.4%  42.7%
        
GAAP Operating Income (Loss) (12,418)  3,898   (28,250)  32,684 
Stock compensation 2,741   3,127   11,919   10,729 
Amortization of acquisition-related intangible assets 103   150   279   1,549 
Reduction in workforce severance 849      3,258   3,265 
Inventory reserve for product line discontinuance 1,000      1,000    
Loss on impairment    3,326   4,392   10,829 
Transformation related expenses          707 
Transaction costs 980   650   980   650 
Government grant accounting          2,036 
Change in fair value of acquisition-related contingent consideration          (99)
Non-GAAP Operating Income (Loss) (6,745)  11,151   (6,422)  62,350 
        
GAAP Net Income (Loss) (10,794)  20,073  $(19,500)  53,655 
Stock compensation 2,741   3,127   11,919   10,729 
Amortization of acquisition-related intangible assets 103   150   279   1,549 
Reduction in workforce severance 849      3,258   3,264 
Inventory reserve for product line discontinuance 1,000      1,000    
Loss on impairment    3,326   4,392   10,829 
Transformation related expenses          707 
Transaction costs 980   650   980   650 
Change in fair value of acquisition-related contingent consideration          (99)
Loss on equity investment 529      1,700    
Additional profit from government contract    (12,802)     (12,802)
Tax effect of non-GAAP adjustments 362   (1,003)  (85)  (2,171)
Non-GAAP Net Income (Loss)$(4,230) $13,521  $3,943  $66,311 
        
GAAP Earnings (Loss) Per Share:$(0.14) $0.27  $(0.26) $0.72 
Non-GAAP Earnings (Loss) Per Share:$(0.06) $0.18  $0.05  $0.89 
Diluted Shares Outstanding 74,597   75,013   74,434   74,389 
Diluted Shares Outstanding Used For Computing Non-GAAP Earnings (Loss) Per Share 74,597   75,013   75,329   74,389 
                

The following is a description of the adjustments made to GAAP financial measures:

  • Stock Compensation: non-cash equity-based compensation provided to OraSure employees and directors
  • Amortization of acquisition-related intangible assets: represents recurring amortization charges resulting from the acquisition of intangible assets associated with our business combinations
  • Reduction in workforce severance: termination benefits associated with the Company’s workforce reduction associated with certain business events
  • Inventory reserve for product line discontinuance: represents the write down of inventory associated with the risk assessment line of business that is discontinued
  • Loss on impairment: charges related to the write down of Company’s intangibles, PP&E, or leased assets
  • Transformation related expenses: transitory costs such as consulting and professional fees related to transformation initiatives
  • Government contract accounting: As required under International Accounting Standard Board IAS 20, Accounting for Government Contracts and Disclosure of Government Assistance, our operating expenses associated with the Department of Defense expansion contract are reflected in operating expenses with offsetting reimbursement reflected in other income
  • Change in fair value of acquisition-related contingent consideration: changes in the fair value of contingent consideration liability associated with estimate changes in reaching contingent consideration metrics
  • Loss on equity investment: we have excluded our proportionate share of our equity method investee’s net loss as we do not have direct control over the investee’s operations or resulting revenue and expenses
  • Tax impact associated with non-GAAP adjustments – tax expense/(benefit) due to non-GAAP adjustments

A reconciliation of our non-GAAP measures to their most directly comparable GAAP measures can also be found at: https://orasure.gcs-web.com/gaap-non-gaap-reconciliation

Investor Contact:Media Contact:
Jason PlagmanAmy Koch
VP, Investor RelationsDirector, Corporate Communications
investorinfo@orasure.commedia@orasure.com



FAQ

What caused OraSure's (OSUR) 51% revenue decline in Q4 2024?

The decline was primarily due to the completion of OraSure's largest government COVID-19 contract, with COVID-19 revenues dropping 98% to $1.0 million.

How much did OraSure's (OSUR) core business grow in Q4 2024?

Core revenues grew 10% year-over-year to $36.5 million, with Diagnostics up 9% to $18.8 million and Sample Management Solutions up 14% to $14.8 million.

What is OraSure's (OSUR) financial guidance for Q1 2025?

OraSure expects Q1 2025 revenues of $27.5-31.5 million, including core revenues of $27-31 million and COVID-19 revenues of approximately $0.5 million.

What strategic acquisitions did OraSure (OSUR) make in Q4 2024?

OraSure acquired Sherlock Biosciences for $5.0 million to expand their molecular diagnostics platform, with plans for an FDA submission for CT/NG self-test by end of 2025.

Orasure Tech

NASDAQ:OSUR

OSUR Rankings

OSUR Latest News

OSUR Stock Data

233.48M
72.00M
3.05%
90.64%
2.18%
Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
Link
United States
BETHLEHEM