Post by icemandios on Aug 3, 2021 23:15:44 GMT
OraSure Technologies Reports 2Q21 Revenue of $57.6 Million Driven by Strong Rebound in Core Business
Excluding COVID-19 product revenues, revenues for the second quarter grew 122% YoY and 48% sequentially as the Company’s core business began to return to pre-pandemic revenue levels
Company received three Emergency Use Authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 Rapid Tests for Non-Prescription (OTC), Professional Point-of-Care and Prescription Home Use
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Aug. 03, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended June 30, 2021.
“This quarter, OraSure once again demonstrated strong financial performance highlighted by a recovery in our core business as the Company began to return to pre-pandemic revenue levels. Importantly, we have now received three EUAs for our InteliSwab™ COVID-19 Rapid Tests, signed up two major distributors, and established a significant pipeline of sales inquiries. This represents a significant achievement as we continue to demonstrate the ability of the Company to develop and launch new products,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies.
Dr. Tang continued, “As we look to the second half of the year we believe the business is well positioned for year-over-year growth given the commercial launch of InteliSwab™. We are responding to strong global customer interest for InteliSwab™ tests and anticipate exiting the year at a significant revenue run rate. Newer areas such as our microbiome kits and services business are becoming increasingly important to our growth story and achieved record revenue in the second quarter. Overall, we are highly focused on spurring innovation, strengthening our product pipeline, and deploying capital through strategically sound acquisitions that leverage our commercial infrastructure to drive long-term sustained growth and value for our stockholders.”
Financial Highlights
Net revenues for the second quarter of 2021 were $57.6 million, a 97% increase from the second quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 122% YoY and 48% sequentially as the company began to return to pre-pandemic revenue levels.
Total revenues from the Company’s Diagnostic business unit were $19.3 million during the second quarter of 2021 and grew 85% relative to the same period last year. Revenue growth was driven predominantly by higher global OraQuick ® HIV and OraQuick ® HCV sales as clinics returned to testing for these critical diseases, along with higher risk assessment testing due to an increase in workplace testing.
Total product and service revenues for the Company’s Molecular Solutions business unit were $38.3 million during the second quarter of 2021, an increase of 103% from the second quarter of 2020.
The increase was driven by strengthening demand for genomic collection kits from commercial and academic customers, growth in microbiome collection kits and services, and modestly higher COVID-19 collection kit sales.
Gross margin percentage in the second quarter was 53.2% compared to 59.0% in the prior year.
Gross margins were negatively impacted by the build out of manufacturing capacity to support the InteliSwab™ COVID-19 Rapid Test launch as well as the higher mix of HIV testing revenue from international markets which carries a lower gross margin than the corporate average. We also saw an impact from increased labor and material costs.
Operating income in the second quarter was $1.8 million compared to a loss of ($9.4) million in the second quarter of last year. Improved operating profit was driven by higher revenues and expense control with total operating expenses only increasing 8% year-over-year despite the 97% overall revenue growth.
Net loss for the second quarter of 2021 was ($1.4) million, or ($0.02) per share on a fully-diluted basis, compared to a net loss of ($10.5) million, or ($0.16) per share on a fully-diluted basis, for the second quarter of 2020.
Cash flow used in operations in the quarter was ($3.4) million. Cash and investments totaled $229.4 million at June 30, 2021.
Recent Business Highlights
COVID-19 Testing
OraSure received three Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 Rapid Tests. The FDA has authorized these tests for Over-the-Counter (OTC) use without a prescription. 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. The OTC and POC tests can be used for those with or without symptoms, when tested twice over two to three days, with 24-36 hours between tests.
As anticipated, due to the timing of EUA for InteliSwab™ and the time required for product relabeling, OraSure did not recognize InteliSwab™ sales in the second quarter of 2021. OraSure signed distribution agreements for this product with two major U.S. distributors for US clinical and physician office channels. Additionally, we currently have significant customer inquiries, including inquiries from over 15 different countries that will accept FDA EUA product with appropriate country specific documents and labeling.
Following discussions with the FDA and their de-prioritization of antibody testing in the U.S., OraSure has decided to no longer pursue EUAs for its oral fluid COVID-19 antibody test. The Company will continue to offer the product for research use only and has several labs interested in COVID antibody surveillance and research applications.
Infectious Disease and Risk Assessment Testing
Global OraQuick ® HIV sales in the second quarter were $10.9 million versus $7.1 million in the prior year period. Sales increased due to improved domestic HIV sales along with continued strong double-digit international test volume growth.
OraSure Technologies was selected by the Centers for Disease Control and Prevention (CDC) to distribute 100,000 HIV self-test kits to individuals who request them. The program sent out OraQuick ® In-Home HIV Tests, which allow an individual to detect antibodies to both HIV-1 and HIV-2 with an oral test, and provide results in 20 minutes, at home.
Global OraQuick ® HCV sales grew 208% to $4.3 million in the second quarter compared to $1.4 million in the second quarter of 2020 as professional testing was reinstated in many countries.
Risk assessment testing revenue grew 71% in the second quarter to $2.6 million based primarily upon increased workplace drugs-of-abuse testing as economic conditions and hiring have improved.
Molecular Solutions
Genomics collection kit revenue of $19.6 million for the second quarter of 2021 grew 203% YoY. The growth was driven predominantly by growth in the key markets of consumer genomics, disease risk management, companion animal and research.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing increased year-over-year to $11.5 million in the second quarter of 2021 compared to $8.5 million in the prior year period. However, on a sequential basis total sales declined by $15.9 million as total U.S. PCR based test volumes for COVID-19 declined meaningfully from the March 2021 quarter to the June 2021 quarter.
A new study was published in Gynecologic Oncology where the data indicated the ability of Colli-Pee ® , OraSure’s proprietary urine sample collection technology, to facilitate test results for human papilloma virus (HPV) using first-void urine samples from patients. In the study of approximately 500 women, the accuracy of testing utilizing Abbott’s RealTi me High Risk HPV assay was statistically equivalent using Colli-Pee ® first-void urine-based samples as compared to clinician collected cervical tissue cell samples.
Total microbiome revenue, including kits and services, was $6.0 million in the quarter and grew 94% relative to the second quarter of last year. OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
Third Quarter 2021 Guidance
The Company expects third quarter 2021 net revenues to range from $45 million to $50 million.
The Company has also provided guidance for InteliSwab™ for the full year stating that in now anticipates total InteliSwab™ sales through December 2021 of approximately $30 million with the preponderance of revenue coming in the fourth quarter of calendar year 2021.
The Company expects fiscal year 2021 total revenue of approximately $230 million.
Excluding COVID-19 product revenues, revenues for the second quarter grew 122% YoY and 48% sequentially as the Company’s core business began to return to pre-pandemic revenue levels
Company received three Emergency Use Authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 Rapid Tests for Non-Prescription (OTC), Professional Point-of-Care and Prescription Home Use
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Aug. 03, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended June 30, 2021.
“This quarter, OraSure once again demonstrated strong financial performance highlighted by a recovery in our core business as the Company began to return to pre-pandemic revenue levels. Importantly, we have now received three EUAs for our InteliSwab™ COVID-19 Rapid Tests, signed up two major distributors, and established a significant pipeline of sales inquiries. This represents a significant achievement as we continue to demonstrate the ability of the Company to develop and launch new products,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies.
Dr. Tang continued, “As we look to the second half of the year we believe the business is well positioned for year-over-year growth given the commercial launch of InteliSwab™. We are responding to strong global customer interest for InteliSwab™ tests and anticipate exiting the year at a significant revenue run rate. Newer areas such as our microbiome kits and services business are becoming increasingly important to our growth story and achieved record revenue in the second quarter. Overall, we are highly focused on spurring innovation, strengthening our product pipeline, and deploying capital through strategically sound acquisitions that leverage our commercial infrastructure to drive long-term sustained growth and value for our stockholders.”
Financial Highlights
Net revenues for the second quarter of 2021 were $57.6 million, a 97% increase from the second quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 122% YoY and 48% sequentially as the company began to return to pre-pandemic revenue levels.
Total revenues from the Company’s Diagnostic business unit were $19.3 million during the second quarter of 2021 and grew 85% relative to the same period last year. Revenue growth was driven predominantly by higher global OraQuick ® HIV and OraQuick ® HCV sales as clinics returned to testing for these critical diseases, along with higher risk assessment testing due to an increase in workplace testing.
Total product and service revenues for the Company’s Molecular Solutions business unit were $38.3 million during the second quarter of 2021, an increase of 103% from the second quarter of 2020.
The increase was driven by strengthening demand for genomic collection kits from commercial and academic customers, growth in microbiome collection kits and services, and modestly higher COVID-19 collection kit sales.
Gross margin percentage in the second quarter was 53.2% compared to 59.0% in the prior year.
Gross margins were negatively impacted by the build out of manufacturing capacity to support the InteliSwab™ COVID-19 Rapid Test launch as well as the higher mix of HIV testing revenue from international markets which carries a lower gross margin than the corporate average. We also saw an impact from increased labor and material costs.
Operating income in the second quarter was $1.8 million compared to a loss of ($9.4) million in the second quarter of last year. Improved operating profit was driven by higher revenues and expense control with total operating expenses only increasing 8% year-over-year despite the 97% overall revenue growth.
Net loss for the second quarter of 2021 was ($1.4) million, or ($0.02) per share on a fully-diluted basis, compared to a net loss of ($10.5) million, or ($0.16) per share on a fully-diluted basis, for the second quarter of 2020.
Cash flow used in operations in the quarter was ($3.4) million. Cash and investments totaled $229.4 million at June 30, 2021.
Recent Business Highlights
COVID-19 Testing
OraSure received three Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 Rapid Tests. The FDA has authorized these tests for Over-the-Counter (OTC) use without a prescription. 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. The OTC and POC tests can be used for those with or without symptoms, when tested twice over two to three days, with 24-36 hours between tests.
As anticipated, due to the timing of EUA for InteliSwab™ and the time required for product relabeling, OraSure did not recognize InteliSwab™ sales in the second quarter of 2021. OraSure signed distribution agreements for this product with two major U.S. distributors for US clinical and physician office channels. Additionally, we currently have significant customer inquiries, including inquiries from over 15 different countries that will accept FDA EUA product with appropriate country specific documents and labeling.
Following discussions with the FDA and their de-prioritization of antibody testing in the U.S., OraSure has decided to no longer pursue EUAs for its oral fluid COVID-19 antibody test. The Company will continue to offer the product for research use only and has several labs interested in COVID antibody surveillance and research applications.
Infectious Disease and Risk Assessment Testing
Global OraQuick ® HIV sales in the second quarter were $10.9 million versus $7.1 million in the prior year period. Sales increased due to improved domestic HIV sales along with continued strong double-digit international test volume growth.
OraSure Technologies was selected by the Centers for Disease Control and Prevention (CDC) to distribute 100,000 HIV self-test kits to individuals who request them. The program sent out OraQuick ® In-Home HIV Tests, which allow an individual to detect antibodies to both HIV-1 and HIV-2 with an oral test, and provide results in 20 minutes, at home.
Global OraQuick ® HCV sales grew 208% to $4.3 million in the second quarter compared to $1.4 million in the second quarter of 2020 as professional testing was reinstated in many countries.
Risk assessment testing revenue grew 71% in the second quarter to $2.6 million based primarily upon increased workplace drugs-of-abuse testing as economic conditions and hiring have improved.
Molecular Solutions
Genomics collection kit revenue of $19.6 million for the second quarter of 2021 grew 203% YoY. The growth was driven predominantly by growth in the key markets of consumer genomics, disease risk management, companion animal and research.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing increased year-over-year to $11.5 million in the second quarter of 2021 compared to $8.5 million in the prior year period. However, on a sequential basis total sales declined by $15.9 million as total U.S. PCR based test volumes for COVID-19 declined meaningfully from the March 2021 quarter to the June 2021 quarter.
A new study was published in Gynecologic Oncology where the data indicated the ability of Colli-Pee ® , OraSure’s proprietary urine sample collection technology, to facilitate test results for human papilloma virus (HPV) using first-void urine samples from patients. In the study of approximately 500 women, the accuracy of testing utilizing Abbott’s RealTi me High Risk HPV assay was statistically equivalent using Colli-Pee ® first-void urine-based samples as compared to clinician collected cervical tissue cell samples.
Total microbiome revenue, including kits and services, was $6.0 million in the quarter and grew 94% relative to the second quarter of last year. OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
Third Quarter 2021 Guidance
The Company expects third quarter 2021 net revenues to range from $45 million to $50 million.
The Company has also provided guidance for InteliSwab™ for the full year stating that in now anticipates total InteliSwab™ sales through December 2021 of approximately $30 million with the preponderance of revenue coming in the fourth quarter of calendar year 2021.
The Company expects fiscal year 2021 total revenue of approximately $230 million.