Post by icemandios on Nov 3, 2021 23:14:36 GMT
OraSure Technologies Reports 3Q21 Revenue of $53.9 Million, Signs Three Major U.S. Government Contracts Positioning the Company for Significant InteliSwab™ Growth in FY22
Third quarter revenue of $53.9 million grew 12% year-over-year; excluding COVID-19 product revenues, revenues for the quarter grew 37% from the prior year, demonstrating strong growth
OraSure signs three major U.S. government contracts providing $205 million in government InteliSwab ™ procurement, $109 million for InteliSwab™ manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance and CLIA waiver for InteliSwab ™
Company increases financial guidance range for fiscal year 2021 and is now expecting revenues of $230-$233 million
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Nov. 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 September 30, 2021.
“OraSure demonstrated strong revenue growth and laid the foundation to dramatically scale the size of the Company in fiscal year 2022. Importantly, we signed three major contracts this quarter with the U.S. government: $205 million for InteliSwab™ COVID-19 Rapid Test procurement, $109 million for InteliSwab ™ manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance for InteliSwab ™ . These contracts position OraSure as an important part of the government’s global pandemic response and will lower our cost per product and broaden our customer reach.”
Dr. Tang continued, “We continue to view InteliSwab ™ as an integral part of our long-term growth strategy, as an entrance into the respiratory rapid test market--the largest point-of-care testing market in the world. This provides an unprecedented opportunity to strategically transform our company and improve our long-term growth profile. Given the strong growth we anticipate in 2022, we are highly focused on execution and ramping our manufacturing production to meet demand. We are also actively working to bolster innovation both through internal research and development and external M&A which we believe will drive long-term sustained growth and value for our stockholders.”
Financial Highlights
Net revenues for the third quarter of 2021 were $53.9 million, a 12% increase from the third quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 37% year-over-year representing a continued recovery in the Company’s core business.
Total revenues from the Company’s Diagnostic business unit were $23.5 million during the third quarter of 2021 and grew 44% relative to the same period last year. Revenue growth was driven predominantly by the addition of InteliSwab ™ along with higher global HCV and risk assessment revenues.
Total product and service revenues for the Company’s Molecular Solutions business unit were $30.4 million during the third quarter of 2021, a decline of 4% from the third quarter of 2020. The decline was driven primarily by lower sales of the Company’s COVID-19 molecular collection kits. Excluding these COVID-19 revenues, the molecular solutions business grew 87% year-over-year.
Gross margin percentage in the third quarter was 39.8% compared to 63.1% 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, along with production inefficiencies and higher scrap rates as the Company worked through the scale-up process. 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.
Operating loss in the third quarter was ($13.0) million compared to operating income of $4.4 million in the third quarter of last year. OraSure’s operating loss in the quarter was driven by a ramp in investments to support the InteliSwab ™ launch and higher sales projected for 2022, along with lower gross margins as described above.
Net loss for the third quarter of 2021 was ($15.0) million, or ($0.21) per share on a fully-diluted basis, compared to a net income of $1.0 million, or $0.01 per share on a fully-diluted basis, for the third quarter of 2020.
Cash flow used in operations in the quarter was ($22.6) million. Cash and investments totaled $202.3 million at September 30, 2021.
Recent Business Highlights
InteliSwab ™ COVID-19 Testing
Awarded a procurement contract from the Defense Logistics Agency (DLA) for the Company’s InteliSwab ™ COVID-19 Rapid Test for over-the-counter use, which the DLA estimated to have a value of $205 million. Under the terms of the contract, OraSure will provide its InteliSwab ™ COVID-19 Rapid Test to up to 25,000 sites throughout the United States with the test purchases funded by the U.S. government. The contract will run from October 2021 through September 2022.
Awarded a $109 million contract from the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for InteliSwab ™ COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. The federal funding will be used to expand OraSure’s production capacity by 100 million tests annually, by March 2024.
Announced that the Biomedical Advanced Research Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the InteliSwab ™ COVID-19 Rapid Test from the U.S. Food and Drug Administration (FDA). These authorizations will help ensure the continued availability of InteliSwab ™ products long after the pandemic is declared over.
OraSure has been scaling its weekly manufacturing production for InteliSwab ™ and the Company believes it has isolated the scale-up challenges to variability in certain incoming raw materials and processing steps. We are currently working with vendors and third-party experts to work toward resolution. Importantly, as we look to January of next year, we believe we are on track to scale to approximately four million tests a month, our current installed capacity, assuming resolution of our manufacturing process.
Received U.S. FDA authorization to amend the over-the-counter InteliSwab ™ emergency use authorization to revise the indication for use such that those with symptoms only need to test once and serial testing is only required for those without symptoms and to create a new single-test over-the-counter product with this new indication.
Submitted data from pediatric-specific usability and clinical studies to the U.S. FDA to expand the age range enabling use of InteliSwab ™ with individuals two and older, and to revise our instructions to include the new InteliSwab ™ Connect application for reporting of results.
Confirmed that InteliSwab ™ detects all variants of concern, including the Delta variant, via testing in third party laboratories with live virus.
Infectious Disease and Risk Assessment Testing
Global OraQuick® HIV sales in the third quarter were $10.0 million versus $10.8 million in the prior year period. Despite global test volume growth, revenue declined year-over year due to the expected expiration of the Bill and Melinda Gates Foundation test subsidy when the Company’s four year contract with the Foundation ended in the second quarter of 2021, as well as order timing changes between the second and third quarters.
InteliSwab ™ revenue in the third quarter was $7.7 million, limited by supply as production is scaling up.
Global OraQuick® HCV sales grew 22% to $2.7 million in the third quarter compared to $2.2 million in the third quarter of 2020 as a result of the recovery in testing programs following the pandemic and new marketing initiatives.
Risk assessment testing revenue grew 19% in the third quarter to $2.7 million compared to $2.3 million in 2020 primarily due to increased workplace drugs-of-abuse testing and insurance testing as economic conditions and hiring have improved.
Molecular Solutions
Genomics collection kit revenue of $19.0 million for the third quarter of 2021 grew 125% year-over-year. The growth was driven predominantly by higher sales in the key markets of consumer genomics, disease risk management, companion animal and research as well as accelerated ordering patterns of certain consumer facing customers anticipating strong holiday sales.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing decreased year-over-year to $6.3 million in the third quarter of 2021 compared to $18.8 million in the prior year period. The decline in revenue is attributable to lower testing volumes with core customers, as high vaccination rates and the increasing availability of rapid antigen tests impact lab-based PCR workplace and back to school testing programs.
Total microbiome revenue, including kits and services, was $4.1 million in the quarter and grew 8% relative to the third quarter of last year. OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
Announced plans to launch a new gut metatranscriptome collection kit and metatranscriptome service offering to our microbiome customers through our Diversigen subsidiary by the first quarter of fiscal year 2022.
The Company has developed and submitted for FDA approval a new collection kit for gut microbiome which the company plans to launch commercially in the first half of fiscal year 2022.
Fiscal Year 2021 and Fourth Quarter 2021 Guidance
The Company is increasing its financial guidance range for 2021 and is now calling for revenues of $230 to $233 million compared to previous guidance which called for total revenues of approximately $230 million. For the fourth quarter of 2021, this translates to total revenue of $60 to $63 million. The Company continues to expect total InteliSwab ™ revenue of approximately $30 million for the fiscal year.
8-K with financials
Third quarter revenue of $53.9 million grew 12% year-over-year; excluding COVID-19 product revenues, revenues for the quarter grew 37% from the prior year, demonstrating strong growth
OraSure signs three major U.S. government contracts providing $205 million in government InteliSwab ™ procurement, $109 million for InteliSwab™ manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance and CLIA waiver for InteliSwab ™
Company increases financial guidance range for fiscal year 2021 and is now expecting revenues of $230-$233 million
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
BETHLEHEM, Pa., Nov. 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 September 30, 2021.
“OraSure demonstrated strong revenue growth and laid the foundation to dramatically scale the size of the Company in fiscal year 2022. Importantly, we signed three major contracts this quarter with the U.S. government: $205 million for InteliSwab™ COVID-19 Rapid Test procurement, $109 million for InteliSwab ™ manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance for InteliSwab ™ . These contracts position OraSure as an important part of the government’s global pandemic response and will lower our cost per product and broaden our customer reach.”
Dr. Tang continued, “We continue to view InteliSwab ™ as an integral part of our long-term growth strategy, as an entrance into the respiratory rapid test market--the largest point-of-care testing market in the world. This provides an unprecedented opportunity to strategically transform our company and improve our long-term growth profile. Given the strong growth we anticipate in 2022, we are highly focused on execution and ramping our manufacturing production to meet demand. We are also actively working to bolster innovation both through internal research and development and external M&A which we believe will drive long-term sustained growth and value for our stockholders.”
Financial Highlights
Net revenues for the third quarter of 2021 were $53.9 million, a 12% increase from the third quarter of 2020. Excluding COVID-19 product revenues, revenues for the quarter increased 37% year-over-year representing a continued recovery in the Company’s core business.
Total revenues from the Company’s Diagnostic business unit were $23.5 million during the third quarter of 2021 and grew 44% relative to the same period last year. Revenue growth was driven predominantly by the addition of InteliSwab ™ along with higher global HCV and risk assessment revenues.
Total product and service revenues for the Company’s Molecular Solutions business unit were $30.4 million during the third quarter of 2021, a decline of 4% from the third quarter of 2020. The decline was driven primarily by lower sales of the Company’s COVID-19 molecular collection kits. Excluding these COVID-19 revenues, the molecular solutions business grew 87% year-over-year.
Gross margin percentage in the third quarter was 39.8% compared to 63.1% 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, along with production inefficiencies and higher scrap rates as the Company worked through the scale-up process. 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.
Operating loss in the third quarter was ($13.0) million compared to operating income of $4.4 million in the third quarter of last year. OraSure’s operating loss in the quarter was driven by a ramp in investments to support the InteliSwab ™ launch and higher sales projected for 2022, along with lower gross margins as described above.
Net loss for the third quarter of 2021 was ($15.0) million, or ($0.21) per share on a fully-diluted basis, compared to a net income of $1.0 million, or $0.01 per share on a fully-diluted basis, for the third quarter of 2020.
Cash flow used in operations in the quarter was ($22.6) million. Cash and investments totaled $202.3 million at September 30, 2021.
Recent Business Highlights
InteliSwab ™ COVID-19 Testing
Awarded a procurement contract from the Defense Logistics Agency (DLA) for the Company’s InteliSwab ™ COVID-19 Rapid Test for over-the-counter use, which the DLA estimated to have a value of $205 million. Under the terms of the contract, OraSure will provide its InteliSwab ™ COVID-19 Rapid Test to up to 25,000 sites throughout the United States with the test purchases funded by the U.S. government. The contract will run from October 2021 through September 2022.
Awarded a $109 million contract from the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for InteliSwab ™ COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. The federal funding will be used to expand OraSure’s production capacity by 100 million tests annually, by March 2024.
Announced that the Biomedical Advanced Research Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the InteliSwab ™ COVID-19 Rapid Test from the U.S. Food and Drug Administration (FDA). These authorizations will help ensure the continued availability of InteliSwab ™ products long after the pandemic is declared over.
OraSure has been scaling its weekly manufacturing production for InteliSwab ™ and the Company believes it has isolated the scale-up challenges to variability in certain incoming raw materials and processing steps. We are currently working with vendors and third-party experts to work toward resolution. Importantly, as we look to January of next year, we believe we are on track to scale to approximately four million tests a month, our current installed capacity, assuming resolution of our manufacturing process.
Received U.S. FDA authorization to amend the over-the-counter InteliSwab ™ emergency use authorization to revise the indication for use such that those with symptoms only need to test once and serial testing is only required for those without symptoms and to create a new single-test over-the-counter product with this new indication.
Submitted data from pediatric-specific usability and clinical studies to the U.S. FDA to expand the age range enabling use of InteliSwab ™ with individuals two and older, and to revise our instructions to include the new InteliSwab ™ Connect application for reporting of results.
Confirmed that InteliSwab ™ detects all variants of concern, including the Delta variant, via testing in third party laboratories with live virus.
Infectious Disease and Risk Assessment Testing
Global OraQuick® HIV sales in the third quarter were $10.0 million versus $10.8 million in the prior year period. Despite global test volume growth, revenue declined year-over year due to the expected expiration of the Bill and Melinda Gates Foundation test subsidy when the Company’s four year contract with the Foundation ended in the second quarter of 2021, as well as order timing changes between the second and third quarters.
InteliSwab ™ revenue in the third quarter was $7.7 million, limited by supply as production is scaling up.
Global OraQuick® HCV sales grew 22% to $2.7 million in the third quarter compared to $2.2 million in the third quarter of 2020 as a result of the recovery in testing programs following the pandemic and new marketing initiatives.
Risk assessment testing revenue grew 19% in the third quarter to $2.7 million compared to $2.3 million in 2020 primarily due to increased workplace drugs-of-abuse testing and insurance testing as economic conditions and hiring have improved.
Molecular Solutions
Genomics collection kit revenue of $19.0 million for the third quarter of 2021 grew 125% year-over-year. The growth was driven predominantly by higher sales in the key markets of consumer genomics, disease risk management, companion animal and research as well as accelerated ordering patterns of certain consumer facing customers anticipating strong holiday sales.
Sales of OraSure’s sample collection devices for molecular/PCR COVID-19 testing decreased year-over-year to $6.3 million in the third quarter of 2021 compared to $18.8 million in the prior year period. The decline in revenue is attributable to lower testing volumes with core customers, as high vaccination rates and the increasing availability of rapid antigen tests impact lab-based PCR workplace and back to school testing programs.
Total microbiome revenue, including kits and services, was $4.1 million in the quarter and grew 8% relative to the third quarter of last year. OraSure’s Diversigen business now supports over 50 commercial customers including over 30 biopharmaceutical customers with 20 ongoing clinical trials.
Announced plans to launch a new gut metatranscriptome collection kit and metatranscriptome service offering to our microbiome customers through our Diversigen subsidiary by the first quarter of fiscal year 2022.
The Company has developed and submitted for FDA approval a new collection kit for gut microbiome which the company plans to launch commercially in the first half of fiscal year 2022.
Fiscal Year 2021 and Fourth Quarter 2021 Guidance
The Company is increasing its financial guidance range for 2021 and is now calling for revenues of $230 to $233 million compared to previous guidance which called for total revenues of approximately $230 million. For the fourth quarter of 2021, this translates to total revenue of $60 to $63 million. The Company continues to expect total InteliSwab ™ revenue of approximately $30 million for the fiscal year.
8-K with financials