Post by icemandios on Feb 24, 2022 0:12:58 GMT
OraSure Technologies Reports 4Q21 Revenue of $63.6 Million; InteliSwab® Production Scales Up
Total 2021 revenue of $233.7 million, up 36% year-over year
InteliSwab ® receives emergency use authorization expansion and demonstrates accurate detection of Omicron variant
InteliSwab ® revenue of $14.7 million in Q4, up 92% sequentially
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Feb. 23, 2022 (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 December 31, 2021 and fiscal year 2021.
“We are pleased to have delivered record revenue from both our Diagnostics and Molecular Solutions business units in our 2021 fiscal year,” said OraSure President and CEO Stephen Tang, Ph.D.
“InteliSwab ® is an outstanding product in terms of its combination of simplicity and accuracy, and we are excited about its growth potential. OraSure has confirmed through an outside independent laboratory that InteliSwab ® detects the live Omicron variant at the same level as other variants of concern. Furthermore, we received FDA Emergency Use Authorization for our pediatric claim and for the InteliSwab ® Connect reporting app which further enhance the value proposition of the product.”
Dr. Tang continued, “We continue to scale up InteliSwab ® production which includes plans for commissioning additional production sites. We continue to address the many typical challenges associated with scale up which will take time to fully implement. Even so, we expect InteliSwab ® to scale modestly in the first quarter and then more meaningfully throughout the year. In addition, we continue to execute our multi-omic strategy which drove 35% year-over-year growth in Molecular Solutions, and have aggressive plans to continue expanding our product offerings in the coming years. As we look ahead, I remain confident in our team’s ability to deliver strong growth and improving operating performance.”
Financial Highlights
Net revenues for the fourth quarter of 2021 were $63.6 million, a 1% increase from the fourth quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 3% year-over-year.
Total revenues from the Company’s Diagnostic business unit were $32.7 million during the fourth quarter of 2021 and grew 58% relative to the same period last year. Revenue growth was driven entirely by the increase in InteliSwab ® revenue on a year-over-year basis.
Total product and service revenues for the Company’s Molecular Solutions business unit were $30.9 million during the fourth quarter of 2021, a decline of 27% from the fourth quarter of 2020. The decline was driven entirely by lower sales of the Company’s COVID-19 molecular collection kits.
Excluding these COVID-19 revenues, the molecular solutions business grew 19% year-over-year despite changes in ordering patterns from the Company’s direct-to-consumer customers.
Gross margin percentage in the fourth quarter was 42.7% compared to 60.7% in the prior year.
Gross margins were negatively impacted by inefficiencies in the InteliSwab ® manufacturing process as the Company worked through initial process automation start up and scale up. Additionally, gross margins were negatively impacted by the expiration of the Bill and Melinda Gates Foundation subsidy for international OraQuick ® HIV self-tests and a less favorable product mix. Gross margins were positively impacted from the impact of the employee retention credit under the CARES Act in the quarter.
Operating loss in the fourth quarter was ($9.4) million compared to operating income of $7.9 million in the fourth quarter of last year. OraSure’s operating loss in the quarter was driven by a ramp in investments to support the InteliSwab ® launch, along with lower gross margins as described above. On a sequential basis, operating profit improved by $3.6 million.
Net loss for the fourth quarter of 2021 was ($10.4) million, or ($0.14) per share on a fully diluted basis, compared to a net income of $1.9 million, or $0.03 per share on a fully-diluted basis, for the fourth quarter of 2020.
Cash flow used in operations in the quarter was ($12.8) million. Cash and investments totaled $170.0 million at December 31, 2021. As of December 31, 2021, the Company also had $10.9 million in funds committed to the capacity expansion build out associated with the Department of Defense contract which should be reimbursed in the first quarter of fiscal year 2022.
Recent Business Highlights
InteliSwab ® COVID-19 Testing
InteliSwab ® revenue in the quarter grew to $14.7 million representing 92% sequential growth relative to the third quarter.
OraSure has been scaling its weekly manufacturing production for InteliSwab ® . At the end of the fourth-quarter, OraSure restructured its business units to vertically integrate operations within them, and appointed a President with a track record of successful leadership of large-scale manufacturing operations.
To accelerate production scale up, OraSure has hired an operations consulting firm used by NIH RADx with deep expertise in manufacturing scale up in med tech and diagnostics.
OraSure announced that its InteliSwab ® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab ® was previously authorized for self-testing use in adults and in children 15 to 17 when administered by an adult.
The Company launched a new reporting app, InteliSwab ® Connect, which will allow people to easily save their test results and report them to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace. The app will be available on the Apple App Store and via Google Play.
OraSure announced that the InteliSwab ® COVID-19 rapid tests detect the Omicron variant as effectively as they detect the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta and Gamma.
Infectious Disease and Risk Assessment Testing
Global OraQuick ® HIV sales in the fourth quarter were $12.4 million versus $15.2 million in the prior year period. The decline in revenue was predominantly attributable to the international market which was impacted by two factors. First, international HIV revenue was negatively impacted by the expiration of the Bill and Melinda Gates Foundation test subsidy which occurred in June 2021. Second, the global coronavirus pandemic created logistic delays in shipping our HIV self-tests into numerous countries.
The Company launched the OraQuick ® HIV Self-Test, an oral swab in-home test for HIV-1 and HIV-2, into Europe. The test will be available in six European countries: United Kingdom, Germany, France, Italy, Spain and Portugal.
Global OraQuick ® HCV sales increased 7% to $2.4 million in the fourth quarter compared to $2.2 million in the fourth quarter of 2020.
Risk assessment testing revenue was flat year-over-year at $2.4 million primarily due to increased workplace drugs-of-abuse testing offset by continued challenges in insurance testing given the COVID-19 pandemic.
Molecular Solutions
Genomics collection kit revenue of $14.0 million for the fourth quarter of 2021 grew 3% year-over-year despite changes in ordering patterns with many direct-to-consumer companies purchasing larger kit quantities in the third quarter prior to the fourth quarter promotional season. For the full year, genomic kit revenue grew 72% to $63.4 million demonstrating strong growth from existing customers, new customer expansion, and a recovery in clinical and academic markets following global pandemic.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing decreased year-over-year to $8.0 million in the fourth quarter of 2021 compared to $22.9 million in the prior year period. The decline in revenue is attributable to lower testing volumes with core customers as the market transitions to point-of-care solutions such as rapid antigen tests.
Total microbiome revenue, including kits and services, was $5.9 million in the quarter and grew 65% relative to the fourth quarter of last year.
OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
The Company announced the planned launch of a new gut metatranscriptome collection kit in first half 2022, to complement the gut metatranscriptome service offering from our Diversigen business launched in the fourth quarter of 2021.
Orasure received the first and only U.S. FDA clearance of a new collection kit for gut microbiome which the company plans to launch commercially in the first half of fiscal year 2022.
Strategic Alternatives Review and Fiscal Year 2022 and First Quarter 2022 Financial Guidance
On January 5, 2022, the Company announced it is exploring strategic alternatives. The review is ongoing, and no decision has been made. Accordingly, the Company is not providing fiscal year 2022 or first-quarter 2022 financial guidance at this time.
Financial Data (Unaudited)
Total 2021 revenue of $233.7 million, up 36% year-over year
InteliSwab ® receives emergency use authorization expansion and demonstrates accurate detection of Omicron variant
InteliSwab ® revenue of $14.7 million in Q4, up 92% sequentially
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Feb. 23, 2022 (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 December 31, 2021 and fiscal year 2021.
“We are pleased to have delivered record revenue from both our Diagnostics and Molecular Solutions business units in our 2021 fiscal year,” said OraSure President and CEO Stephen Tang, Ph.D.
“InteliSwab ® is an outstanding product in terms of its combination of simplicity and accuracy, and we are excited about its growth potential. OraSure has confirmed through an outside independent laboratory that InteliSwab ® detects the live Omicron variant at the same level as other variants of concern. Furthermore, we received FDA Emergency Use Authorization for our pediatric claim and for the InteliSwab ® Connect reporting app which further enhance the value proposition of the product.”
Dr. Tang continued, “We continue to scale up InteliSwab ® production which includes plans for commissioning additional production sites. We continue to address the many typical challenges associated with scale up which will take time to fully implement. Even so, we expect InteliSwab ® to scale modestly in the first quarter and then more meaningfully throughout the year. In addition, we continue to execute our multi-omic strategy which drove 35% year-over-year growth in Molecular Solutions, and have aggressive plans to continue expanding our product offerings in the coming years. As we look ahead, I remain confident in our team’s ability to deliver strong growth and improving operating performance.”
Financial Highlights
Net revenues for the fourth quarter of 2021 were $63.6 million, a 1% increase from the fourth quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 3% year-over-year.
Total revenues from the Company’s Diagnostic business unit were $32.7 million during the fourth quarter of 2021 and grew 58% relative to the same period last year. Revenue growth was driven entirely by the increase in InteliSwab ® revenue on a year-over-year basis.
Total product and service revenues for the Company’s Molecular Solutions business unit were $30.9 million during the fourth quarter of 2021, a decline of 27% from the fourth quarter of 2020. The decline was driven entirely by lower sales of the Company’s COVID-19 molecular collection kits.
Excluding these COVID-19 revenues, the molecular solutions business grew 19% year-over-year despite changes in ordering patterns from the Company’s direct-to-consumer customers.
Gross margin percentage in the fourth quarter was 42.7% compared to 60.7% in the prior year.
Gross margins were negatively impacted by inefficiencies in the InteliSwab ® manufacturing process as the Company worked through initial process automation start up and scale up. Additionally, gross margins were negatively impacted by the expiration of the Bill and Melinda Gates Foundation subsidy for international OraQuick ® HIV self-tests and a less favorable product mix. Gross margins were positively impacted from the impact of the employee retention credit under the CARES Act in the quarter.
Operating loss in the fourth quarter was ($9.4) million compared to operating income of $7.9 million in the fourth quarter of last year. OraSure’s operating loss in the quarter was driven by a ramp in investments to support the InteliSwab ® launch, along with lower gross margins as described above. On a sequential basis, operating profit improved by $3.6 million.
Net loss for the fourth quarter of 2021 was ($10.4) million, or ($0.14) per share on a fully diluted basis, compared to a net income of $1.9 million, or $0.03 per share on a fully-diluted basis, for the fourth quarter of 2020.
Cash flow used in operations in the quarter was ($12.8) million. Cash and investments totaled $170.0 million at December 31, 2021. As of December 31, 2021, the Company also had $10.9 million in funds committed to the capacity expansion build out associated with the Department of Defense contract which should be reimbursed in the first quarter of fiscal year 2022.
Recent Business Highlights
InteliSwab ® COVID-19 Testing
InteliSwab ® revenue in the quarter grew to $14.7 million representing 92% sequential growth relative to the third quarter.
OraSure has been scaling its weekly manufacturing production for InteliSwab ® . At the end of the fourth-quarter, OraSure restructured its business units to vertically integrate operations within them, and appointed a President with a track record of successful leadership of large-scale manufacturing operations.
To accelerate production scale up, OraSure has hired an operations consulting firm used by NIH RADx with deep expertise in manufacturing scale up in med tech and diagnostics.
OraSure announced that its InteliSwab ® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab ® was previously authorized for self-testing use in adults and in children 15 to 17 when administered by an adult.
The Company launched a new reporting app, InteliSwab ® Connect, which will allow people to easily save their test results and report them to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace. The app will be available on the Apple App Store and via Google Play.
OraSure announced that the InteliSwab ® COVID-19 rapid tests detect the Omicron variant as effectively as they detect the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta and Gamma.
Infectious Disease and Risk Assessment Testing
Global OraQuick ® HIV sales in the fourth quarter were $12.4 million versus $15.2 million in the prior year period. The decline in revenue was predominantly attributable to the international market which was impacted by two factors. First, international HIV revenue was negatively impacted by the expiration of the Bill and Melinda Gates Foundation test subsidy which occurred in June 2021. Second, the global coronavirus pandemic created logistic delays in shipping our HIV self-tests into numerous countries.
The Company launched the OraQuick ® HIV Self-Test, an oral swab in-home test for HIV-1 and HIV-2, into Europe. The test will be available in six European countries: United Kingdom, Germany, France, Italy, Spain and Portugal.
Global OraQuick ® HCV sales increased 7% to $2.4 million in the fourth quarter compared to $2.2 million in the fourth quarter of 2020.
Risk assessment testing revenue was flat year-over-year at $2.4 million primarily due to increased workplace drugs-of-abuse testing offset by continued challenges in insurance testing given the COVID-19 pandemic.
Molecular Solutions
Genomics collection kit revenue of $14.0 million for the fourth quarter of 2021 grew 3% year-over-year despite changes in ordering patterns with many direct-to-consumer companies purchasing larger kit quantities in the third quarter prior to the fourth quarter promotional season. For the full year, genomic kit revenue grew 72% to $63.4 million demonstrating strong growth from existing customers, new customer expansion, and a recovery in clinical and academic markets following global pandemic.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing decreased year-over-year to $8.0 million in the fourth quarter of 2021 compared to $22.9 million in the prior year period. The decline in revenue is attributable to lower testing volumes with core customers as the market transitions to point-of-care solutions such as rapid antigen tests.
Total microbiome revenue, including kits and services, was $5.9 million in the quarter and grew 65% relative to the fourth quarter of last year.
OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
The Company announced the planned launch of a new gut metatranscriptome collection kit in first half 2022, to complement the gut metatranscriptome service offering from our Diversigen business launched in the fourth quarter of 2021.
Orasure received the first and only U.S. FDA clearance of a new collection kit for gut microbiome which the company plans to launch commercially in the first half of fiscal year 2022.
Strategic Alternatives Review and Fiscal Year 2022 and First Quarter 2022 Financial Guidance
On January 5, 2022, the Company announced it is exploring strategic alternatives. The review is ongoing, and no decision has been made. Accordingly, the Company is not providing fiscal year 2022 or first-quarter 2022 financial guidance at this time.
Financial Data (Unaudited)