Net Third Quarter Revenues of $48.0 Million Increased 33% Year-Over-Year, Driven by $18.4 Million in Sales of Oral Fluid Collection Devices for COVID-19 Molecular Testing
Company Has Submitted EUA Application For Its Lab-based Oral Fluid SARS-CoV-2 Antibody Test
Management to Host Conference Call and Webcast Today at 5:00 p.m. ET
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three- and nine-month periods ended September 30, 2020.
"We achieved strong top-line results in the third quarter driven by the performance of our Molecular Solutions business unit, which marked its highest quarter ever, with $31.7 million in total revenue. The Company's ability to quickly respond to the need for increased COVID-19 testing resulted in $18.4 million in sales of sample collection devices for molecular testing in the third quarter, which is more than double the COVID-19 related revenue achieved in the first half of the year," said Stephen S. Tang, Ph.D., President and Chief Executive Officer. "We are confident in our ability to meet the massive and persistent need for COVID-19 testing and sample collection. We recently submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for our laboratory-based oral fluid SARS-CoV-2 Antibody test. To date there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S. We continue to make progress on our rapid antigen self-test and have completed studies to confirm the assay's proprietary chemistry. Additionally, we were pleased to see growth in the quarter from our international HIV business."
Third Quarter Financial Highlights
Financial Results for the Three Months Ended September 30, 2020
Net revenues for the third quarter of 2020 of $48.0 million increased 33% from the comparable period of 2019, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing, an increase in international sales of the Company's HIV Self-Test and in laboratory service revenues. These increases were partially offset by lower sales of the Company's genomics, risk assessment, HCV, and domestic HIV products.
Gross profit percentage was 63% and 60% for the three months ended September 30, 2020 and 2019, respectively. Gross profit percentage in the third quarter of 2020 benefited from an improved product mix associated with higher gross profit percentage product sales.
For the three months ended September 30, 2020, operating expenses were $25.9 million, an increase of $17.3 million from the $8.6 million reported for the three months ended September 30, 2019. This increase was due primarily to increased spend associated with COVID-19 product development and the inclusion of expenses incurred by the Company's newly acquired subsidiaries, UrSure and Diversigen, whose results were not included in the third quarter of 2019. In addition, operating expenses in the third quarter of 2019 were reduced by a gain on the sale of the Company's cryosurgical business of $10.1 million and a $2.4 million decrease in the change in the fair value of contingent acquisition consideration.
The Company generated operating income of $4.4 million in the third quarter of 2020 compared to operating income of $13.1 million in the third quarter of 2019.
During the third quarters of 2020 and 2019, the Company recorded income tax expense of $3.7 million and $1.2 million, respectively. Income tax expense in both periods largely consisted of foreign taxes due.
Fourth Quarter 2020 Guidance
The Company expects fourth quarter 2020 net revenues to range from $55 million to $60 million.
Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Results of Operations Net revenues $ 48,011 $ 35,989 $ 108,866 $ 104,937 Cost of products and services sold 17,722 14,343 45,182 40,193 Gross profit 30,289 21,646 63,684 64,744 Operating expenses: Research and development 8,007 4,619 20,575 13,525 Sales and marketing 7,849 8,955 25,339 23,937 General and administrative 10,108 7,556 30,442 23,748 Change in fair value of acquisition-related contingent consideration (60 ) (2,387 ) 390 (843 ) Gain on sale of business -- (10,149 ) -- (10,149 ) Total operating expenses 25,904 8,594 76,746 50,218 Operating income (loss) 4,385 13,052 (13,062 ) 14,526 Other income 314 1,195 1,960 2,243 Income (loss) before income taxes 4,699 14,247 (11,102 ) 16,769 Income tax expense 3,659 1,169 5,680 2,551 Net income (loss) $ 1,040 $ 13,078 $ (16,782 ) $ 14,218 Income (loss) per share: Basic $ 0.01 $ 0.21 $ (0.25 ) $ 0.23 Diluted $ 0.01 $ 0.21 $ (0.25 ) $ 0.23 Weighted average shares: Basic 71,537 61,726 66,088 61,656 Diluted 72,662 62,143 66,088 62,172
Three Months Ended September 30, Dollars Percentage of Total Net Revenues 2020 2019 % Change 2020 2019 Market Infectious disease testing $ 13,224 $ 13,588 (3 ) % 28 % 38 % Risk assessment testing 2,316 3,312 (30 ) 5 9 Cryosurgical systems -- 961 (100 ) -- 3 Molecular collection systems 31,209 17,438 79 65 48 Net product and service revenues 46,749 35,299 32 98 98 Royalty income 450 758 (41 ) 1 2 Other 812 (68 ) -- 1 -- Net revenues $ 48,011 $ 35,989 33 % 100 % 100 %
Nine Months Ended September 30, Dollars Percentage of Total Net Revenues 2020 2019 % Change 2020 2019 Market Infectious disease testing $ 36,625 $ 39,273 (7 ) % 34 % 37 % Risk assessment testing 6,848 9,246 (26 ) 6 9 Cryosurgical systems -- 7,054 (100 ) -- 7 Molecular collection systems 62,499 45,325 38 58 43 Net product and service revenues 105,972 100,898 5 98 96 Royalty income 1,623 2,956 (45 ) 1 3 Other 1,271 1,083 17 1 1 Net revenues $ 108,866 $ 104,937 4 % 100 % 100 %
Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 % Change 2020 2019 % Change OraQuick Revenues Domestic HIV $ 3,909 $ 4,259 (8 ) % $ 11,323 $ 13,024 (13 ) % International HIV 6,865 5,891 17 17,697 15,313 16 Net HIV revenues 10,774 10,150 6 29,020 28,337 -- Domestic HCV 1,186 1,977 (40 ) 3,437 5,907 (42 ) International HCV 1,033 1,129 (9 ) 2,772 3,569 (22 ) Net HCV revenues 2,219 3,106 (29 ) 6,209 9,476 (34 ) Net product revenues $ 12,993 $ 13,256 (2 ) % $ 35,229 $ 37,813 (7 ) %
Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 % Change 2020 2019 % Change Molecular Collection Systems Revenues Genomics $ 8,519 $ 13,647 (38 ) % $ 23,381 $ 35,449 (34 ) % Microbiome 1,828 1,878 (3 ) 4,259 5,325 (20 ) COVID-19 18,441 --ï»¿ N/A 27,307 -- N/A Laboratory services 2,418 1,618 49 7,472 3,947 89 Other product revenues 3 295 (99 ) 80 604 (87 ) Net product and service revenues 31,209 17,438 79 62,499 45,325 38 Other 488 821 (41 ) 1,834 3,277 (44 ) Net product and service revenues $ 31,697 $ 18,259 74 % $ 64,333 $ 48,602 32 %
Condensed Consolidated Balance Sheets (Unaudited) September 30, 2020 December 31, 2019 Assets Cash and cash equivalents $ 162,859 $ 75,715 Short-term investments 72,961 80,623 Accounts receivable, net 30,638 36,948 Inventories 30,488 23,155 Other current assets 6,031 8,109 Property, plant and equipment, net 39,056 30,339 Intangible assets, net 18,111 14,674 Goodwill 39,480 36,201 Long-term investments 27,841 33,420 Other non-current assets 8,945 10,111 Total assets $ 436,410 $ 349,295 Liabilities and Stockholders' Equity Accounts payable $ 14,377 $ 9,567 Deferred revenue 5,311 3,713 Contingent consideration obligation 764 3,500 Other current liabilities 16,775 15,933 Non-current contingent consideration obligation 3,176 112 Other non-current liabilities 8,115 9,325 Stockholders' equity 387,892 307,145 Total liabilities and stockholders' equity $ 436,410 $ 349,295
Additional Financial Data (Unaudited) Nine Months Ended September 30, 2020 2019 Capital expenditures $ 11,234 $ 7,961 Depreciation and amortization $ 7,051 $ 5,532 Stock-based compensation $ 5,913 $ 3,283 Cash provided by operating activities $ 2,196 $ 10,838
The Company will host a conference call and audio webcast for analysts and investors to discuss the Company's 2020 third 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 #9459222 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, November 18, 2020, 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, CoreBiome (now operating under the Diversigen brand), UrSure 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.
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, 2019, 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.
The ORAcollect-- RNA and OMNIgene-- ORAL sample collection devices have not been FDA cleared or approved; the devices have been authorized by FDA under an EUA. The ORAcollect-- RNA and OMNIgene-- ORAL sample collection devices have been authorized only to collect, stabilize, and maintain during transport, saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA), not for any other viruses or pathogens; and
the ORAcollect-- RNA and OMNIgene-- ORAL sample collection devices are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section564(b)(1) of the Federal Food, Drug, and Cosmetic Act,21U.S.C. Â§360bbb-3(b)(1),unless the authorization is terminated or revoked sooner.
Investor contact: Media contact: Sam Martin Jeanne Mell Argot Partners VP Corporate Communications 212-600-1902 484-353-1575 email@example.com firstname.lastname@example.org