Q3 GAAP EPS of $(0.06); Q3 Non-GAAP EPS of $(0.01)

OraQuick® HCV Self-test receives initial orders following receipt of WHO pre-qualification status

Expanding Sample Management applications into blood proteomics

Exiting Risk Assessment testing business to focus on markets with attractive growth opportunities

BETHLEHEM, Pa., Nov. 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 September 30, 2024.

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"Our Q3 results were consistent with our expectations, and we continue to make progress on our strategic transformation. Core revenue improved sequentially in the third quarter and our key end markets are showing signs of gradual recovery. Our sustained focus on operational efficiency is delivering consistent productivity gains, and we generated positive cash flow from operations for the core business in Q3,” said OraSure President and CEO Carrie Eglinton Manner.

She added, "We are winding down our Risk Assessment testing business to focus on opportunities that align with our strengths in Diagnostics and Sample Management and elevate profitable growth in our core. As we position OraSure for a return to growth, our strong balance sheet provides flexibility as we invest in our innovation roadmap, including internal development, partnerships, and potential acquisition opportunities that leverage our existing capabilities.”

Financial Highlights

 For the Three Months Ended September 30, For the Nine Months Ended September 30,
  2024   2023  % Change

  2024   2023  % Change

Core Business (1)$        37,751  $        38,154          (1)% $        102,468  $        109,909          (7)%
Molecular Services         9           834          (99)           1,692           3,567          (53) 
COVID-19         2,155           50,199          (96)           44,222           216,115          (80) 
Total Net Revenues$        39,915  $        89,187          (55)% $        148,382  $        329,591          (55)%
 
(1) Includes Diagnostics, Molecular Sample Management Solutions, other products and services revenues, and non-product and services revenues.
 

 For the Three Months Ended September 30,

 For the Nine Months Ended September 30,
  2024  2023 % Change  2024  2023 % Change

Net revenues$        39,915   $        89,187           (55)% $        148,382   $        329,591           (55)%
Gross profit         17,070            44,340           (62)           65,824            136,526           (52) 
Gross margin         42.8 %          49.7 %              44.4 %          41.4 %    
Non-GAAP gross profit         17,272            44,609           (61)           67,490            137,998           (51) 
Non-GAAP gross margin         43.3 %          50.0 %              45.5 %          41.9 %    
                    
Operating income (loss)         (5,999)           10,894   NM            (15,832)           28,786   NM  
Operating margin        (15.0)%          12.2 %             (10.7)%          8.7 %    
Non-GAAP operating income (loss)         (2,698)           20,568   NM            323            51,198           (99) 
Non-GAAP operating margin        (6.8)%          23.1 %              0.2 %          15.5 %    
                    
Net income (loss)         (4,507)           11,159   NM            (8,706)           33,582   NM  
Non-GAAP net income (loss)         (688)           20,034   NM            8,173            52,790           (85) 
Diluted GAAP EPS$        (0.06)  $        0.15   NM   $        (0.12)  $        0.45   NM  
Diluted Non-GAAP EPS$        (0.01)  $        0.27   NM   $        0.11   $        0.71           (85) 
                            
NM - not meaningful
                            
  • Total net revenues for the third quarter of 2024 decreased 55% to $39.9 million from $89.2 million in the third quarter of 2023.
  • Core revenues (all revenues excluding COVID-19 and Molecular Services revenues) of $37.8 million in the third quarter decreased 1% year-over-year. Diagnostics revenues in the third quarter increased 13% year-over-year to $22.0 million and Molecular Sample Management revenues decreased 16% to $12.8 million. The year-over-year decline in Core revenues was impacted by a decrease in revenues from the Risk Assessment testing business that we are exiting.
  • COVID-19 revenues of $2.2 million in the third quarter decreased 96% year-over-year primarily due to the completion of our largest government contract earlier in 2024.
  • GAAP gross margin percentage was 42.8% in the third quarter of 2024 compared to 49.7% in the third quarter of 2023. Non-GAAP gross margin percentage in the third quarter of 2024 was 43.3% compared to 50.0% in the third quarter of 20231. On a year-over-year basis, gross margin was impacted by the decline in COVID-19 revenues and the higher mix of International revenues.
  • GAAP operating loss in the third quarter of 2024 was $6.0 million compared to operating income of $10.9 million in the third quarter of 2023. Non-GAAP operating loss was $2.7 million in the third quarter of 2024 compared to non-GAAP operating income of $20.6 million in the third quarter of 2023.
  • Cash and cash equivalents were $279 million as of September 30, 2024. Cash flow from operations in the third quarter of 2024 was $12.7 million.
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1 For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules.

Recent Business Developments

  • Received initial international orders for our OraQuick® HCV Self-test following receipt of WHO pre-qualification status in July. The OraQuick® HCV Self-test is the first Hepatitis C self-test to earn this designation, and we are actively working with the global health community to bring this test to populations in need.
  • Expanding our sample management portfolio with the planned launch of a new solution targeting the blood proteomics market in the second half of 2025. Blood proteomics is a large and rapidly growing market, and there is a need for collection devices that effectively stabilize blood proteins in an easy-to-use format.
  • Initiated steps to exit our Risk Assessment testing business by the end of 2024 to focus on markets that offer attractive growth opportunities. Risk Assessment testing products generated revenues