-- 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(TM) 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
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(TM) 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(TM). We are responding to strong global customer interest for InteliSwab(TM) 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."
Recent Business Highlights
Infectious Disease and Risk Assessment Testing
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(TM) for the full year stating that in now anticipates total InteliSwab(TM) 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.
Financial Data (Unaudited)
Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Results of Operations Net revenues $ 57,607 $ 29,259 $ 116,189 $ 60,855 Cost of products and services sold 26,934 11,995 47,190 27,460 Gross profit 30,673 17,264 68,999 33,395 Operating expenses: Research and development 7,682 6,924 16,674 12,568 Sales and marketing 10,420 10,121 19,950 17,490 General and administrative 10,993 10,280 21,181 20,334 Change in fair value of acquisition-related contingent consideration (220 ) (660 ) (1,026 ) 450 Total operating expenses 28,875 26,665 56,779 50,842 Operating income (loss) 1,798 (9,401 ) 12,220 (17,447 ) Other income 448 216 329 1,646 Income (loss) before income taxes 2,246 (9,185 ) 12,549 (15,801 ) Income tax expense 3,610 1,309 10,139 2,021 Net income (loss) $ (1,364 ) $ (10,494 ) $ 2,410 $ (17,822 ) Earnings (loss) per share: Basic $ (0.02 ) $ (0.16 ) $ 0.03 $ (0.28 ) Diluted $ (0.02 ) $ (0.16 ) $ 0.03 $ (0.28 ) Weighted average shares: Basic 71,983 64,745 71,931 63,335 Diluted 71,983 64,745 72,683 63,335
Three Months Ended Six Months Ended June 30, June 30, 2021 2020 % Change 2021 2020 % Change DIAGNOSTICS Infectious Disease Testing Revenues Domestic HIV $ 4,135 $ 3,197 29 % $ 9,050 $ 7,414 22 % International HIV 6,809 3,883 75 10,672 10,832 (1 ) Net HIV revenues 10,944 7,080 55 19,722 18,246 8 Domestic HCV 2,571 757 240 3,754 2,251 67 International HCV 1,729 641 170 2,914 1,738 68 Net HCV revenues 4,300 1,398 208 6,668 3,989 67 Net OraQuick(R) revenues 15,244 8,478 80 26,390 22,235 19 Other infectious disease revenues 379 259 46 604 1,165 (48 ) Total Infectious Disease 15,623 8,737 79 26,994 23,400 15 Risk Assessment 2,629 1,533 71 4,591 4,533 1 Other non-product revenues 1,059 157 575 2,272 286 694 TOTAL DIAGNOSTIC NET REVENUE $ 19,311 $ 10,427 85 % $ 33,857 $ 28,219 20 % MOLECULAR SOLUTIONS Genomics $ 19,582 $ 6,471 203 % $ 30,646 $ 14,863 106 Microbiome 2,853 853 234 4,941 2,430 103 COVID-19 11,491 8,472 36 38,880 8,866 339 Laboratory services 3,114 2,222 40 5,611 5,053 11 Other product and services revenues 449 49 816 657 78 742 Net product and service revenues 37,489 18,067 107 80,735 31,290 158 Other non-product and service revenues 807 765 5 1,597 1,346 19 TOTAL MOLECULAR SOLUTIONS NET REVENUE $ 38,296 $ 18,832 103 % $ 82,332 $ 32,636 152 TOTAL NET REVENUES $ 57,607 $ 29,259 97 % $ 116,189 $ 60,855 91 %
Condensed Consolidated Balance Sheets (Unaudited) June 30, 2021 December 31, 2020 Assets Cash and cash equivalents $ 158,120 $ 160,802 Short-term investments 35,185 48,599 Accounts receivable, net 35,259 38,835 Inventories 48,170 31,863 Other current assets 8,316 8,794 Property, plant and equipment, net 72,034 51,860 Intangible assets, net 16,241 17,904 Goodwill 40,810 40,351 Long-term investments 36,131 47,718 Other non-current assets 14,783 7,746 Total assets $ 465,049 $ 454,472 Liabilities and Stockholders' Equity Accounts payable $ 22,119 $ 17,407 Deferred revenue 4,240 4,811 Contingent consideration obligation 219 402 Other current liabilities 19,994 23,869 Non-current contingent consideration obligation 800 2,049 Other non-current liabilities 12,861 7,363 Stockholders' equity 404,816 398,571 Total liabilities and stockholders' equity $ 465,049 $ 454,472
Additional Financial Date (Unaudited) Six Months Ended June 30, 2021 2020 Capital expenditures $ 22,929 $ 6,037 Depreciation and amortization $ 5,524 $ 4,600 Stock-based compensation $ 2,937 $ 4,048 Cash used in operating activities $ 3,472 $ 2,184
The Company will host a conference call and audio webcast for analysts and investors to discuss the Company's second quarter 2021 results and certain business developments, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Dr. Stephen S. Tang, President and Chief Executive Officer, and Roberto Cuca, Chief Financial Officer. The call will include prepared remarks by management and a question and answer session.
In order to listen to the conference call, please dial (888) 771-4371 (Domestic) or (847) 585-4405 (International) and reference Conference ID # 50205303 or go to OraSure Technologies' web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies' web site shortly after the call has ended and will be available for 14 days. A replay of the call can also be accessed until midnight, August 17, 2021, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID # 50205303.
It is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on OraSure's Investor Relations page.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure's portfolio of products is sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations 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: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management's attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; 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 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 U.S. Food and Drug Administration ("FDA") or other regulators; the impact of the novel coronavirus ("COVID-19") pandemic on our business and our 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; 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; ability to meet increased demand for the Company's products; 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; ability to identify, complete, integrate and realize the full benefits of future acquisitions; 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 Centers for Disease Control and Prevention ("CDC") or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company's stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
Investor Contact: Media Contact: Scott Gleason Amy Koch SVP Investor Relations & Corporate Communications Sr. Mgr. Corporate Communications 484-425-0588 484-523-1815 firstname.lastname@example.org email@example.com