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Share Name | Share Symbol | Market | Type |
---|---|---|---|
OraSure Technologies Inc | NASDAQ:OSUR | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.30 | 4.18 | 4.55 | 0 | 09:00:00 |
“OraSure continues to successfully navigate the pandemic, with a record-breaking fourth quarter and double-digit full-year revenue growth driven by a strong sequential quarterly increase in sales of our molecular sample collection kits for COVID-19 testing. We expect this strong sustained performance to persist as testing continues to be a key strategy to combat the ongoing pandemic. Our base business was resilient, with demonstrated strength in international HIV testing,” said Stephen S. Tang, Ph.D., President and Chief Executive Officer.
Dr. Tang continued, “Importantly, we have made substantial progress on our COVID-19 Rapid Antigen Self-Test and oral fluid antibody test. We expect that OraSure’s COVID-19 activities will continue to accelerate the Company’s growth and significantly outweigh any negative impact of the pandemic on other parts of our business. We have locked the proprietary assay chemistry and completed development and clinical testing of our rapid antigen test for COVID-19. We accelerated the Prescription Self-Test trials and now plan to submit for both the Professional and Prescription Self-Test for Emergency Use Authorization (EUA) by the end of this month. We are also planning to resubmit two separate EUAs for our lab-based oral fluid antibody test, including additional analytical study data, as requested by the FDA, and look forward to bringing this important product to market as soon as possible.”
Financial Highlights
COVID-19 Update
Molecular/PCR:
Antigen:
Antibody:
Manufacturing:
Financial Results for the Three Months Ended December 31, 2020
Net revenues for the fourth quarter of 2020 of $62.9 million increased 27% from the comparable period of 2019, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing and increased international sales of the Company’s HIV Self-Test partially offset by declines in revenues of our other product lines largely due to the impact of COVID-19.
Gross profit percentage was 61% for the three months ended December 31, 2020 compared to 60% for the three months ended December 31, 2019. Gross profit in the current quarter benefited from an improved product mix associated with higher gross profit percentage product sales.
For the three months ended December 31, 2020, operating expenses were $30.3 million, an increase of $4.1 million from the $25.8 million reported for the three months ended December 31, 2019, largely due to increased investment in the development of the Company’s COVID products.
The Company generated operating income of $7.9 million in the fourth quarter of 2020 compared to operating income of $4.1 million in the fourth quarter of 2019.
During the fourth quarters of 2020 and 2019, the Company recorded income tax expense of $5.7 million and $2.1 million, respectively. Income tax expense in both periods largely consisted of foreign taxes due related to our Canadian subsidiary.
First Quarter 2021 Guidance
The Company expects first quarter 2021 net revenues to range from $55.0 million to $60.0 million.
Financial Data (Unaudited)
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Results of Operations | ||||||||||||||||
Net revenues | $ | 62,855 | $ | 49,668 | $ | 171,721 | $ | 154,605 | ||||||||
Cost of products and services sold | 24,671 | 19,829 | 69,853 | 60,022 | ||||||||||||
Gross profit | 38,184 | 29,839 | 101,868 | 94,583 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 10,457 | 6,104 | 31,032 | 19,629 | ||||||||||||
Sales and marketing | 9,120 | 7,932 | 34,459 | 31,869 | ||||||||||||
General and administrative | 12,211 | 11,539 | 42,653 | 35,287 | ||||||||||||
Change in fair value of acquisition-related contingent consideration | (1,489 | ) | 179 | (1,099 | ) | (664 | ) | |||||||||
Gain on sale of business | — | — | — | (10,149 | ) | |||||||||||
Total operating expenses | 30,299 | 25,754 | 107,045 | 75,972 | ||||||||||||
Operating income (loss) | 7,885 | 4,085 | (5,177 | ) | 18,611 | |||||||||||
Other income (expense) | (307 | ) | 477 | 1,653 | 2,720 | |||||||||||
Income (loss) before income taxes | 7,578 | 4,562 | (3,524 | ) | 21,331 | |||||||||||
Income tax expense | 5,718 | 2,124 | 11,398 | 4,675 | ||||||||||||
Net income (loss) | $ | 1,860 | $ | 2,438 | $ | (14,922 | ) | $ | 16,656 | |||||||
Earnings (loss) per share: | ||||||||||||||||
Basic | $ | 0.03 | $ | 0.04 | $ | (0.22 | ) | $ | 0.27 | |||||||
Diluted | $ | 0.03 | $ | 0.04 | $ | (0.22 | ) | $ | 0.27 | |||||||
Weighted average shares: | ||||||||||||||||
Basic | 71,723 | 61,729 | 67,505 | 61,675 | ||||||||||||
Diluted | 72,817 | 62,199 | 67,505 | 62,170 | ||||||||||||
Three Months Ended December 31, | |||||||||||||||||||||||
Dollars | Percentage of Total Net Revenues | ||||||||||||||||||||||
2020 | 2019 | %Change | 2020 | 2019 | |||||||||||||||||||
Market | |||||||||||||||||||||||
Infectious disease testing | $ | 17,602 | $ | 18,743 | (6 | ) | % | 28 | % | 38 | % | ||||||||||||
Risk assessment testing | 2,526 | 2,944 | (14 | ) | 4 | 6 | |||||||||||||||||
Molecular solutions | 40,281 | 25,487 | 58 | 64 | 51 | ||||||||||||||||||
Net product and service revenues | 60,409 | 47,174 | 28 | 96 | 95 | ||||||||||||||||||
Royalty income | 1,809 | 2,160 | (16 | ) | 3 | 4 | |||||||||||||||||
Other | 637 | 334 | 91 | 1 | 1 | ||||||||||||||||||
Net revenues | $ | 62,855 | $ | 49,668 | 27 | % | 100 | % | 100 | % |
Year Ended December 31, | |||||||||||||||||||||||
Dollars | Percentage of Total Net Revenues | ||||||||||||||||||||||
2020 | 2019 | %Change | 2020 | 2019 | |||||||||||||||||||
Market | |||||||||||||||||||||||
Infectious disease testing | $ | 54,227 | $ | 58,016 | (7 | ) | % | 32 | % | 38 | % | ||||||||||||
Risk assessment testing | 9,374 | 12,189 | (23 | ) | 5 | 8 | |||||||||||||||||
Cryosurgical systems | — | 7,054 | (100 | ) | — | 5 | |||||||||||||||||
Molecular solutions | 102,780 | 70,814 | 45 | 60 | 45 | ||||||||||||||||||
Net product and service revenues | 166,381 | 148,073 | 12 | 97 | 96 | ||||||||||||||||||
Royalty income | 3,432 | 5,116 | (33 | ) | 2 | 3 | |||||||||||||||||
Other | 1,908 | 1,416 | 35 | 1 | 1 | ||||||||||||||||||
Net revenues | $ | 171,721 | $ | 154,605 | 11 | % | 100 | % | 100 | % |
Three Months Ended | Year Ended | ||||||||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||||||||
2020 | 2019 | %Change | 2020 | 2019 | %Change | ||||||||||||||||||||
OraQuick® Revenues | |||||||||||||||||||||||||
Domestic HIV | $ | 3,861 | $ | 4,960 | (22 | ) | % | $ | 15,184 | $ | 17,984 | (16 | ) | % | |||||||||||
International HIV | 11,343 | 9,795 | 16 | 29,040 | 25,108 | 16 | |||||||||||||||||||
Net HIV revenues | 15,204 | 14,755 | 3 | 44,224 | 43,092 | 3 | |||||||||||||||||||
Domestic HCV | 1,356 | 2,202 | (38 | ) | 4,793 | 8,108 | (41 | ) | |||||||||||||||||
International HCV | 884 | 1,295 | (32 | ) | 3,655 | 4,864 | (25 | ) | |||||||||||||||||
Net HCV revenues | 2,240 | 3,497 | (36 | ) | 8,448 | 12,972 | (35 | ) | |||||||||||||||||
Net product revenues | $ | 17,444 | $ | 18,252 | (4 | ) | % | $ | 52,672 | $ | 56,064 | (6 | ) | % |
Three Months Ended | Year Ended | |||||||||||||||||||||||||
December 31, | December 31, | |||||||||||||||||||||||||
2020 | 2019 | %Change | 2020 | 2019 | %Change | |||||||||||||||||||||
Molecular Solutions Revenues | ||||||||||||||||||||||||||
Genomics | $ | 13,760 | $ | 20,761 | (34 | ) | % | $ | 37,141 | $ | 56,212 | (34 | ) | % | ||||||||||||
Microbiome | 1,898 | 1,847 | 3 | 6,156 | 7,172 | (14 | ) | |||||||||||||||||||
COVID-19 | 22,494 | — | N/A | 49,802 | — | N/A | ||||||||||||||||||||
Laboratory services | 2,093 | 2,820 | (26 | ) | 9,564 | 6,767 | 41 | |||||||||||||||||||
Other product revenues | 36 | 59 | (39 | ) | 117 | 663 | (82 | ) | ||||||||||||||||||
Net product and service revenues | 40,281 | 25,487 | 58 | 102,780 | 70,814 | 45 | ||||||||||||||||||||
Other | 1,866 | 2,289 | (18 | ) | 3,701 | 5,566 | (34 | ) | ||||||||||||||||||
Net revenues | $ | 42,147 | $ | 27,776 | 52 | % | $ | 106,481 | $ | 76,380 | 39 | % | ||||||||||||||
Condensed Consolidated Balance Sheets (Unaudited)
December 31, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 160,802 | $ | 75,715 | ||||
Short-term investments | 48,599 | 80,623 | ||||||
Accounts receivable, net | 38,835 | 36,948 | ||||||
Inventories | 31,863 | 23,155 | ||||||
Other current assets | 8,794 | 8,109 | ||||||
Property, plant and equipment, net | 51,860 | 30,339 | ||||||
Intangible assets, net | 17,904 | 14,674 | ||||||
Goodwill | 40,351 | 36,201 | ||||||
Long-term investments | 47,718 | 33,420 | ||||||
Other non-current assets | 7,746 | 10,111 | ||||||
Total assets | $ | 454,472 | $ | 349,295 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Accounts payable | $ | 17,407 | $ | 9,567 | ||||
Deferred revenue | 4,811 | 3,713 | ||||||
Contingent consideration obligation | 402 | 3,500 | ||||||
Other current liabilities | 23,869 | 15,933 | ||||||
Non-current contingent consideration obligation | 2,049 | 112 | ||||||
Other non-current liabilities | 7,363 | 9,325 | ||||||
Stockholders’ equity | 398,571 | 307,145 | ||||||
Total liabilities and stockholders’ equity | $ | 454,472 | $ | 349,295 |
Additional Financial Data (Unaudited)
Year Ended | ||||||||
December 31, | ||||||||
2020 | 2019 | |||||||
Capital expenditures | $ | 26,674 | $ | 9,314 | ||||
Depreciation and amortization | $ | 9,714 | $ | 7,730 | ||||
Stock-based compensation | $ | 7,139 | $ | 4,057 | ||||
Cash provided by operating activities | $ | 5,807 | $ | 9,804 |
Conference Call
The Company will host a conference call and audio webcast for analysts and investors to discuss the Company’s 2020 full year and fourth quarter 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 844-831-3030 (Domestic) or 315-625-6887 (International) and reference Conference ID # 8168847 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 seven days. A replay of the call can also be accessed until midnight, March 15, 2021, by dialing 855-859-2056 (Domestic) or (404) 537-3406 (International) and entering the Conference ID #9459222.
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. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen and Novosanis, OraSure 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.
Important Information
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: |
Sam Martin | Jeanne Mell |
Argot Partners | OraSure Technologies |
212-600-1902 | 484-353-1575 |
orasure@argotpartners.com | media@orasure.com |
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