OraSure Reports Q2 ’24 Revenue of $54.3 Million
Q2 GAAP EPS of
OraQuick® HCV Self-test is the first globally to earn
Strong momentum with Syphilis Health Check™ launch
Expanding Sample Management applications into saliva-based liquid biopsy
“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
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 |
For the Six Months Ended |
||||||||||||||||||||||
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)
For the Three Months Ended |
For the Six Months Ended |
||||||||||||||||||||||
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 decreased 7% year-over-year. Diagnostics revenues in the second quarter decreased 5% year-over-year and Molecular Sample Management revenues decreased 3%. 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 decreased 60% 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 to 30.9% in the second quarter of 2023. Non-GAAP gross margin percentage in the second quarter of 2024 was 47.4% compared to 31.7% 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 ofJune 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 individualswho 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 |
For the Six Months Ended |
||||||||||||||
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 |
For the Six Months Ended |
||||||||||||||||||||||
2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||||||||||||
Consolidated Net Revenues | |||||||||||||||||||||||
$ | 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)
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 | |||||
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 |
|||||||
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 |
|||||||
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
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
About InteliSwab®
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
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
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 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 |
For the Six Months Ended |
||||||||||||||
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: VP, Investor Relations investorinfo@orasure.com |
Media Contact: Director, Corporate Communications media@orasure.com |
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Source: OraSure Technologies, Inc.