OraSure Reports Q2 ’24 Revenue of $54.3 Million
OraSure Technologies reported Q2 2024 financial results with total revenue of $54.3 million, down 36% year-over-year. Core revenue decreased 7% to $35.4 million, while COVID-19 revenue fell 60% to $18.9 million. The company achieved a GAAP EPS of $(0.01) and non-GAAP EPS of $0.07. Key highlights include:
- OraQuick HCV Self-test became the first globally to earn WHO pre-qualification
- Strong momentum with Syphilis Health Check launch
- Expanding Sample Management applications into saliva-based liquid biopsy
- On track to achieve operating cash flow break-even for core business by end of 2024
OraSure expects Q3 2024 revenues of $37-$41 million, including Core revenues of $36-$39 million and InteliSwab revenues of $1-$2 million.
OraSure Technologies ha riportato i risultati finanziari del secondo trimestre 2024, con un fatturato totale di 54,3 milioni di dollari, in calo del 36% rispetto all'anno precedente. Il fatturato core è diminuito del 7% a 35,4 milioni di dollari, mentre il fatturato legato al COVID-19 è sceso del 60% a 18,9 milioni di dollari. L'azienda ha registrato un EPS GAAP di $(0,01) e un EPS non GAAP di $0,07. I punti salienti includono:
- OraQuick HCV Self-test è diventato il primo al mondo a ottenere la prequalifica dell'OMS
- Forte slancio con il lancio di Syphilis Health Check
- Espansione delle applicazioni di gestione dei campioni in biopsia liquida basata sulla saliva
- In carreggiata per raggiungere il pareggio di flusso di cassa operativo per il core business entro la fine del 2024
OraSure prevede ricavi per il terzo trimestre 2024 compresi tra 37 e 41 milioni di dollari, inclusi fatturati core tra 36 e 39 milioni di dollari e ricavi di InteliSwab tra 1 e 2 milioni di dollari.
OraSure Technologies reportó los resultados financieros del segundo trimestre de 2024, con un ingreso total de 54.3 millones de dólares, un 36% menos en comparación con el año anterior. Los ingresos fundamentales disminuyeron un 7% a 35.4 millones de dólares, mientras que los ingresos por COVID-19 cayeron un 60% a 18.9 millones de dólares. La empresa logró un EPS GAAP de $(0.01) y un EPS no GAAP de $0.07. Los aspectos más destacados incluyen:
- OraQuick HCV Autoexamen se convirtió en el primero a nivel global en obtener la precalificación de la OMS
- Fuerte impulso con el lanzamiento de Syphilis Health Check
- Expansión de aplicaciones de Gestión de Muestras en biopsia líquida basada en saliva
- En camino a lograr el equilibrio de flujo de caja operativo para el negocio principal para finales de 2024
OraSure espera ingresos para el tercer trimestre de 2024 de entre 37 y 41 millones de dólares, incluyendo ingresos fundamentales de entre 36 y 39 millones de dólares y ingresos de InteliSwab de entre 1 y 2 millones de dólares.
OraSure Technologies는 2024년 2분기 재무 결과를 보고하였으며, 총 수익이 5430만 달러로 작년 대비 36% 감소했습니다. 핵심 수익은 7% 줄어든 3540만 달러였고, COVID-19 관련 수익은 60% 감소해 1890만 달러로 집계되었습니다. 회사는 GAAP EPS $(0.01) 및 비-GAAP EPS $0.07를 달성했습니다. 주요 강조 사항은 다음과 같습니다:
- OraQuick HCV 자가검사가 WHO 사전 자격을 획득한 최초의 제품이 되었습니다.
- Syphilis Health Check 출시로 강력한 모멘텀을 확보했습니다.
- 샘플 관리 애플리케이션을 침 기반 액체 생검으로 확장하고 있습니다.
- 2024년 말까지 핵심 사업 운영 현금 흐름 균형을 이룰 예정입니다.
OraSure는 2024년 3분기 수익이 3700만 달러에서 4100만 달러 사이일 것으로 예상하며, 여기에는 핵심 수익 3600만 달러에서 3900만 달러 및 InteliSwab 수익 100만 달러에서 200만 달러가 포함됩니다.
OraSure Technologies a annoncé les résultats financiers du deuxième trimestre 2024, avec un chiffre d'affaires total de 54,3 millions de dollars, en baisse de 36% par rapport à l'année précédente. Le chiffre d'affaires principal a diminué de 7% pour atteindre 35,4 millions de dollars, tandis que le chiffre d'affaires lié au COVID-19 a chuté de 60% pour atteindre 18,9 millions de dollars. L'entreprise a obtenu un EPS GAAP de $(0,01) et un EPS non-GAAP de $0,07. Les faits marquants comprennent :
- Le test auto-diagnostic OraQuick HCV est devenu le premier au monde à obtenir la préqualification de l'OMS
- Forte dynamique avec le lancement de Syphilis Health Check
- Expansion des applications de gestion des échantillons pour inclure la biopsie liquide à base de salive
- Prêt à atteindre l'équilibre du flux de trésorerie opérationnel pour son activité principale d'ici fin 2024
OraSure prévoit des revenus de 37 à 41 millions de dollars pour le troisième trimestre de 2024, y compris des revenus principaux de 36 à 39 millions de dollars et des revenus d'InteliSwab de 1 à 2 millions de dollars.
OraSure Technologies hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht, mit Gesamteinnahmen von 54,3 Millionen Dollar, was einem Rückgang von 36% im Vergleich zum Vorjahr entspricht. Die Kerneinnahmen sanken um 7% auf 35,4 Millionen Dollar, während die Einnahmen aus COVID-19 um 60% auf 18,9 Millionen Dollar fielen. Das Unternehmen erzielte ein GAAP EPS von $(0,01) und ein non-GAAP EPS von $0,07. Zu den wichtigsten Höhepunkten gehören:
- Der OraQuick HCV Selbsttest wurde der erste weltweit, der die WHO-Vorausqualifizierung erhielt.
- Starke Dynamik mit dem Start des Syphilis Health Check.
- Erweiterung der Anwendung des Sample Management auf speichelbasierte Flüssigbiopsie.
- Auf Kurs, um bis Ende 2024 einen operativen Cashflow-Break-Even für das Kerngeschäft zu erreichen.
OraSure erwartet im dritten Quartal 2024 Einnahmen von 37 bis 41 Millionen Dollar, einschließlich Kerneinnahmen von 36 bis 39 Millionen Dollar und InteliSwab-Einnahmen von 1 bis 2 Millionen Dollar.
- OraQuick HCV Self-test became first globally to earn WHO pre-qualification
- Strong momentum with Syphilis Health Check launch
- Expanding Sample Management applications into saliva-based liquid biopsy
- Non-GAAP gross margin improved to 47.4% from 31.7% year-over-year
- Achieved non-GAAP operating income of $3.3 million vs. loss of $2.0 million in Q2 2023
- Cash flow from operations in Q2 2024 was $7.8 million
- Strong cash position with $267.4 million in cash, cash equivalents, and short-term investments
- Total revenue decreased 36% year-over-year to $54.3 million
- Core revenue declined 7% to $35.4 million
- COVID-19 revenue fell 60% to $18.9 million
- GAAP operating loss of $2.7 million in Q2 2024
- Net loss of $615,000 in Q2 2024
OraSure's Q2 results show a mixed performance. While total revenue of
The improved gross margin (GAAP:
The Q3 guidance of
OraSure's strategic pivot towards high-potential markets is noteworthy. The WHO prequalification for their OraQuick® HCV Self-test is a significant milestone, potentially opening up a vast market of 50 million HCV patients globally. This aligns with the growing trend of self-testing in healthcare.
The company's expansion into saliva-based liquid biopsy for oncology is a smart move, tapping into the rapidly growing precision medicine market. The momentum in sexual health diagnostics, particularly with Syphilis Health Check™, indicates OraSure's ability to identify and capitalize on unmet medical needs.
These developments, coupled with innovations like the new packaging for HIV Self-Test, position OraSure well in the evolving diagnostics landscape. However, the success will depend on market adoption rates and competitive dynamics in these new areas.
Q2 GAAP EPS of
OraQuick® HCV Self-test is the first globally to earn WHO pre-qualification
Strong momentum with Syphilis Health Check™ launch
Expanding Sample Management applications into saliva-based liquid biopsy
BETHLEHEM, Pa., Aug. 06, 2024 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended June 30, 2024.
“Our team continues to execute well, delivering Q2 results that were near the top end of our revenue guidance range. Our second quarter Core revenue showed sequential improvement, and we anticipate further progress in Q3. We continue to strengthen our foundation, elevate our core business, and accelerate our profitable growth through investments in innovation while maintaining focus on cost efficiency and margin expansion,” said OraSure President and CEO Carrie Eglinton Manner.
She continued, “We are seeing positive momentum from our product launches and extensions that expand access, especially in large market opportunities such as sexual health and liquid biopsy. Additionally, our discipline and execution in consolidating sites, reducing operating costs, and leveraging automation continues to unlock productivity gains, and we remain on track to achieve our target of break-even in cash flow from operations for the core business by the end of 2024. Our streamlined cost structure, along with our strong balance sheet, provides flexibility for the next stage of our transformation. Overall, we are confident that OTI is well positioned to leverage the strength of our differentiated platforms and customer relationships to drive profitable growth as key end markets recover further in 2025 and beyond.”
Financial Highlights
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||||||||||||
| Core Business (1) | $ | 35,396 | $ | 37,934 | (7 | )% | $ | 66,400 | $ | 74,488 | (11 | )% | |||||||||||
| COVID-19 | 18,939 | 47,507 | (60 | ) | 42,067 | 165,916 | (75 | ) | |||||||||||||||
| Total Net Revenue | $ | 54,335 | $ | 85,441 | (36 | )% | $ | 108,467 | $ | 240,404 | (55 | )% | |||||||||||
(1) Includes Diagnostics, Molecular Sample Management Solutions, Molecular Services, other products and services revenues, and non-product and services revenues.
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||||||||||||
| Net revenues | $ | 54,335 | $ | 85,441 | (36 | )% | $ | 108,467 | $ | 240,404 | (55 | )% | |||||||||||
| Gross profit | 24,689 | 26,371 | (6 | ) | 48,754 | 92,186 | (47 | ) | |||||||||||||||
| Gross margin | 45.4 | % | 30.9 | % | 44.9 | % | 38.3 | % | |||||||||||||||
| Non-GAAP gross profit | 25,771 | 27,112 | (5 | ) | 50,218 | 93,389 | (46 | ) | |||||||||||||||
| Non-GAAP gross margin | 47.4 | % | 31.7 | % | 46.3 | % | 38.8 | % | |||||||||||||||
| Operating income (loss) | (2,740 | ) | (6,429 | ) | (57 | ) | (9,833 | ) | 17,892 | NM | |||||||||||||
| Operating margin | (5.0 | )% | (7.5 | )% | (9.1 | )% | 7.4 | % | |||||||||||||||
| Non-GAAP operating income (loss) | 3,346 | (2,028 | ) | NM | 3,021 | 30,630 | (90 | ) | |||||||||||||||
| Non-GAAP operating margin | 6.2 | % | (2.4 | )% | 2.8 | % | 12.7 | % | |||||||||||||||
| Net income (loss) | (615 | ) | (4,796 | ) | (87 | ) | (4,199 | ) | 22,423 | NM | |||||||||||||
| Non-GAAP net income (loss) | 5,219 | (1,800 | ) | NM | 8,305 | 32,756 | (75 | ) | |||||||||||||||
| GAAP EPS | $ | (0.01 | ) | $ | (0.07 | ) | (86 | ) | $ | (0.06 | ) | $ | 0.30 | NM | |||||||||
| Non-GAAP EPS | $ | 0.07 | $ | (0.02 | ) | NM | $ | 0.11 | $ | 0.44 | (75 | ) | |||||||||||
NM – not meaningful
- Total net revenues for the second quarter of 2024 decreased
36% to$54.3 million from$85.4 million in the second quarter of 2023. - Core revenues (all revenues excluding COVID-19 revenues) of
$35.4 million in the second quarter decreased7% year-over-year. Diagnostics revenues in the second quarter decreased5% year-over-year and Molecular Sample Management revenues decreased3% . The year-over-year decline in Core revenues was also impacted by a decrease in revenues from the Molecular Services business that we are exiting and a decline in Non-product and services revenues. - COVID-19 revenues of
$18.9 million in the second quarter decreased60% year-over-year, which was in line with the Company’s expectations as volumes under our largest government contract tapered down. - GAAP gross margin percentage was
45.4% in the second quarter of 2024 compared to30.9% in the second quarter of 2023. Non-GAAP gross margin percentage in the second quarter of 2024 was47.4% compared to31.7% in the second quarter of 20231. On a year-over-year basis, gross margin benefited from operational efficiency initiatives and lower manufacturing scrap expense. Gross margin in the second quarter of 2023 included$7.0 million of accelerated depreciation expense and$1.8 million for inventory reserves. - GAAP operating loss in the second quarter of 2024 was
$2.7 million compared to operating loss of$6.4 million in the second quarter of 2023. Non-GAAP operating income was$3.3 million in the second quarter of 2024 compared to non-GAAP operating loss of$2.0 million in the second quarter of 2023. - Cash, cash equivalents, and short-term investments were
$267.4 million as of June 30, 2024. Cash flow from operations in the second quarter of 2024 was$7.8 million .
Recent Business Developments
- Achieved prequalification status from the World Health Organization for our OraQuick® HCV Self-test, representing the first Hepatitis C self-test to earn this designation. OraSure is proud to add this milestone to our legacy of “firsts” in the diagnostic industry, and we look forward to working with the global health community to bring this test to populations in need, including the 50 million people living with HCV and 1 million individuals who acquire HCV each year.
- Received FDA approval for a new packaging and labeling configuration for our OraQuick® HIV Self-Test, which is expected to result in reduced plastic usage and increased shipping efficiencies. In addition to sustainability improvements, the new packaging also includes updated language regarding linkage to care, treatment options, and preventative therapies.
- Generating positive momentum with Syphilis Health Check™ following our launch at the end of Q1, including strong interest from both existing and new customers.
- Broadened our relationships with several leading oncology companies to expand ORACollect® Dx collection devices into saliva-based liquid biopsy.
- Remain on track to achieve operating cash flow break-even for the core business by the end of 2024.
Financial Guidance
The Company is guiding to Q3 2024 revenues of
_______________
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.
Financial Data (Unaudited)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Results of Operations | |||||||||||||||
| Net revenues | $ | 54,335 | $ | 85,441 | $ | 108,467 | $ | 240,404 | |||||||
| Cost of products and services sold | 29,646 | 59,070 | 59,713 | 148,218 | |||||||||||
| Gross profit | 24,689 | 26,371 | 48,754 | 92,186 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 6,599 | 7,661 | 14,337 | 18,221 | |||||||||||
| Sales and marketing | 7,931 | 8,535 | 16,379 | 20,677 | |||||||||||
| General and administrative | 11,845 | 16,424 | 23,479 | 34,135 | |||||||||||
| Loss on impairments | 1,054 | 215 | 4,392 | 1,320 | |||||||||||
| Change in the estimated fair value of acquisition-related contingent consideration | — | (35 | ) | — | (59 | ) | |||||||||
| Total operating expenses | 27,429 | 32,800 | 58,587 | 74,294 | |||||||||||
| Operating income (loss) | (2,740 | ) | (6,429 | ) | (9,833 | ) | 17,892 | ||||||||
| Other income | 3,066 | 1,467 | 6,557 | 4,140 | |||||||||||
| Income (loss) before income taxes | 326 | (4,962 | ) | (3,276 | ) | 22,032 | |||||||||
| Income tax expense (benefit) | 381 | (166 | ) | 363 | (391 | ) | |||||||||
| Loss on equity investment | (560 | ) | — | (560 | ) | — | |||||||||
| Net income (loss) | $ | (615 | ) | $ | (4,796 | ) | $ | (4,199 | ) | $ | 22,423 | ||||
| Income (loss) per share: | |||||||||||||||
| Basic | $ | (0.01 | ) | $ | (0.07 | ) | $ | (0.06 | ) | $ | 0.31 | ||||
| Diluted | $ | (0.01 | ) | $ | (0.07 | ) | $ | (0.06 | ) | $ | 0.30 | ||||
| Weighted average shares outstanding: | |||||||||||||||
| Basic | 74,159 | 73,324 | 74,127 | 73,219 | |||||||||||
| Diluted | 74,159 | 73,324 | 74,127 | 74,115 | |||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||||||||||||
| Consolidated Net Revenues | |||||||||||||||||||||||
| COVID-19 Diagnostics | $ | 18,934 | $ | 47,477 | (60 | )% | $ | 42,031 | $ | 165,731 | (75 | )% | |||||||||||
| Diagnostics | 18,746 | 19,834 | (5 | ) | 35,139 | 36,924 | (5 | ) | |||||||||||||||
| Molecular Sample Management Solutions | 12,609 | 13,050 | (3 | ) | 23,431 | 25,992 | (10 | ) | |||||||||||||||
| Other products and services | 2,845 | 2,993 | (5 | ) | 5,408 | 6,087 | (11 | ) | |||||||||||||||
| Molecular Services | 810 | 1,354 | (40 | ) | 1,683 | 2,733 | (38 | ) | |||||||||||||||
| COVID-19 Molecular Products | 5 | 30 | (83 | ) | 36 | 185 | (81 | ) | |||||||||||||||
| Net product and services revenues | 53,949 | 84,738 | (36 | ) | 107,728 | 237,652 | (55 | ) | |||||||||||||||
| Non-product and services revenues | 386 | 703 | (45 | ) | 739 | 2,752 | (73 | ) | |||||||||||||||
| Net revenues | $ | 54,335 | $ | 85,441 | (36 | )% | $ | 108,467 | $ | 240,404 | (55 | )% | |||||||||||
Condensed Consolidated Balance Sheets (Unaudited)
| June 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 258,239 | $ | 290,407 | |||
| Short-term investments | 9,142 | — | |||||
| Accounts receivable, net | 38,097 | 40,171 | |||||
| Inventories | 38,255 | 47,614 | |||||
| Other current assets | 7,329 | 8,267 | |||||
| Property, plant and equipment, net | 40,313 | 45,420 | |||||
| Intangible assets, net | 829 | 1,206 | |||||
| Goodwill | 34,964 | 35,696 | |||||
| Investment in equity method investee | 27,773 | — | |||||
| Other noncurrent assets | 11,402 | 14,064 | |||||
| Total assets | $ | 466,343 | $ | 482,845 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Accounts payable | $ | 9,085 | $ | 13,151 | |||
| Deferred revenue | 1,445 | 1,559 | |||||
| Other current liabilities | 18,322 | 24,826 | |||||
| Other noncurrent liabilities | 11,651 | 12,638 | |||||
| Stockholders’ equity | 425,840 | 430,671 | |||||
| Total liabilities and stockholders’ equity | $ | 466,343 | $ | 482,845 | |||
Additional Financial Data (Unaudited)
| For the Six Months Ended June 30, | |||||||
| 2024 | 2023 | ||||||
| Capital expenditures | $ | 3,196 | $ | 6,927 | |||
| Proceeds from funding under government contract (1) | — | 17,793 | |||||
| Depreciation and amortization | 5,331 | 14,011 | |||||
| Stock-based compensation | 6,290 | 5,012 | |||||
| Cash provided by operating activities | $ | 14,583 | $ | 63,270 | |||
(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 Six Months Ended June 30, | |||||||
| 2024 | 2023 | ||||||
| OPERATING ACTIVITIES: | |||||||
| Net (loss) income | $ | (4,199 | ) | $ | 22,423 | ||
| Adjustments to reconcile net (loss) income to net cash provided by operating activities: | |||||||
| Stock-based compensation | 6,290 | 5,012 | |||||
| Depreciation and amortization | 5,331 | 14,011 | |||||
| Loss on impairments | 4,392 | 1,320 | |||||
| Other non-cash amortization | (88 | ) | 1 | ||||
| Provision for credit losses | 149 | (478 | ) | ||||
| Unrealized foreign currency (gain) loss | (48 | ) | 106 | ||||
| Interest expense on finance leases | 13 | 28 | |||||
| Loss on equity investment | 560 | — | |||||
| Deferred income taxes | 91 | (1,815 | ) | ||||
| Change in the estimated fair value of acquisition-related contingent consideration | — | (59 | ) | ||||
| Payment of acquisition-related contingent consideration | — | (19 | ) | ||||
| Changes in assets and liabilities: | |||||||
| Accounts receivable | 1,802 | 18,652 | |||||
| Inventories | 9,220 | 22,556 | |||||
| Prepaid expenses and other assets | 1,727 | 5,495 | |||||
| Accounts payable | (3,469 | ) | (22,187 | ) | |||
| Deferred revenue | (105 | ) | (450 | ) | |||
| Accrued expenses and other liabilities | (7,083 | ) | (1,326 | ) | |||
| Net cash provided by operating activities | 14,583 | 63,270 | |||||
| INVESTING ACTIVITIES: | |||||||
| Purchases of short-term investments | (53,244 | ) | — | ||||
| Purchase of equity method investee | (28,333 | ) | — | ||||
| Proceeds from maturities and redemptions of short-term investments | 43,908 | 27,305 | |||||
| Purchases of property and equipment | (3,196 | ) | (2,893 | ) | |||
| Purchase of property and equipment under government contracts | — | (4,034 | ) | ||||
| Proceeds from funding under government contract (1) | — | 17,793 | |||||
| Net cash provided by (used in) investing activities | (40,865 | ) | 38,171 | ||||
| FINANCING ACTIVITIES: | |||||||
| Cash payments for lease liabilities | (107 | ) | (320 | ) | |||
| Proceeds from exercise of stock options | 215 | 66 | |||||
| Payment of acquisition-related contingent consideration | — | (46 | ) | ||||
| Repurchase of common stock | (3,446 | ) | (1,663 | ) | |||
| Net cash used in financing activities | (3,338 | ) | (1,963 | ) | |||
| EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH | (2,547 | ) | 2,478 | ||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (32,168 | ) | 101,956 | ||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 290,407 | 83,980 | |||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 258,239 | $ | 185,936 | |||
Conference Call
The Company will host a conference call and audio webcast to discuss the Company’s second quarter 2024 results and certain business developments, beginning today at 5 p.m. Eastern Time. On the call will be Carrie Eglinton Manner, President and Chief Executive Officer, and Ken McGrath, Chief Financial Officer. 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 OraSure’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 OraSure’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/BIe57bba25d853415d8352e2aa4f12a85a
About OraSure Technologies
OraSure Technologies, Inc. (“OraSure”) 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 subsidiary, DNA Genotek 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 InteliSwab®
OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab® COVID-19 rapid tests. The U.S. Food and Drug Administration (“FDA”) has authorized the InteliSwab® COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab® COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab® COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. The InteliSwab® test’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.”
This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA. The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Development of the InteliSwab® COVID-19 Rapid Test 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; Biomedical Advanced Research and Development Authority, under contract numbers 75A50120C00061 and 75A50121C00078, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab® COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). The manufacturing effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.
Forward Looking Statements
This press release contains certain forward-looking statements, including with respect to products, product 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 achieve the anticipated cost savings as a result of our business restructuring, including from insourcing third party manufacturing and exiting microbiome services; 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 impact of the novel coronavirus (“COVID-19”) pandemic or other public health crises on the Company's business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and 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; ability of the Company to achieve its financial and strategic objectives and continue to increase its 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 oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; 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 the Company’s 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 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 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 June 30, | For the Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | $ | 54,335 | $ | 85,441 | $ | 108,467 | $ | 240,404 | |||||||
| GAAP Cost of products and services sold | 29,646 | 59,070 | 59,713 | 148,218 | |||||||||||
| GAAP Gross Margin | 45.4 | % | 30.9 | % | 44.9 | % | 38.3 | % | |||||||
| Stock compensation | 193 | 155 | 344 | 289 | |||||||||||
| Amortization of acquisition-related intangible assets | — | 132 | — | 264 | |||||||||||
| Reduction in workforce severance | 889 | 334 | 1,120 | 369 | |||||||||||
| Transformation related expenses | — | 120 | — | 281 | |||||||||||
| Non-GAAP Cost of Goods Sold | 28,564 | 58,329 | 58,249 | 147,015 | |||||||||||
| Non-GAAP Gross Margin | 47.4 | % | 31.7 | % | 46.3 | % | 38.8 | % | |||||||
| GAAP Operating Income (Loss) | (2,740 | ) | (6,429 | ) | (9,833 | ) | 17,892 | ||||||||
| Stock compensation | 3,322 | 2,357 | 6,289 | 5,012 | |||||||||||
| Amortization of acquisition-related intangible assets | 58 | 466 | 117 | 932 | |||||||||||
| Reduction in workforce severance | 1,652 | 629 | 2,056 | 3,264 | |||||||||||
| Loss on impairment | 1,054 | 215 | 4,392 | 1,320 | |||||||||||
| Transformation related expenses | — | 232 | — | 681 | |||||||||||
| Government grant accounting | — | 537 | — | 1,588 | |||||||||||
| Change in fair value of acquisition-related contingent consideration | — | (35 | ) | — | (59 | ) | |||||||||
| Non-GAAP Operating Income (Loss) | 3,346 | (2,028 | ) | 3,021 | 30,630 | ||||||||||
| GAAP Net Income (Loss) | (615 | ) | (4,796 | ) | $ | (4,199 | ) | 22,423 | |||||||
| Stock compensation | 3,322 | 2,357 | 6,289 | 5,012 | |||||||||||
| Amortization of acquisition-related intangible assets | 58 | 466 | 117 | 932 | |||||||||||
| Reduction in workforce severance | 1,652 | 629 | 2,056 | 3,264 | |||||||||||
| Loss on impairment | 1,054 | 215 | 4,392 | 1,320 | |||||||||||
| Transformation related expenses | — | 232 | — | 681 | |||||||||||
| Change in fair value of acquisition-related contingent consideration | — | (35 | ) | — | (59 | ) | |||||||||
| Tax effect of Non-GAAP adjustments | (252 | ) | (868 | ) | (350 | ) | (817 | ) | |||||||
| Non-GAAP Net Income | $ | 5,219 | $ | (1,800 | ) | $ | 8,305 | $ | 32,756 | ||||||
| GAAP Earnings (Loss) Per Share: | $ | (0.01 | ) | $ | (0.07 | ) | $ | (0.06 | ) | $ | 0.30 | ||||
| Non-GAAP Earnings Per Share: | $ | 0.07 | $ | (0.02 | ) | $ | 0.11 | $ | 0.44 | ||||||
| Diluted Shares Outstanding | 74,159 | 73,324 | 74,127 | 74,115 | |||||||||||
| Diluted Shares Outstanding Used For Computing Non-GAAP Earnings (Loss) Per Share | 75,169 | 74,290 | 75,460 | 74,115 | |||||||||||
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: one-time termination benefits associated with the Company’s workforce reduction
- Loss on impairment: charges related to the write down of Company’s PP&E and 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
- 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: Jason Plagman VP, Investor Relations investorinfo@orasure.com | Media Contact: Amy Koch Director, Corporate Communications media@orasure.com | |
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