OraSure Technologies Inc
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Health Care : Health Care Equipment & Supplies | Small Cap Growth
Company profile

OraSure Technologies, Inc. (OraSure) is a medical device company that develops, manufactures, and markets medical devices and diagnostic products. The Company's products include molecular sampling kits for the genome and microbiome services and analytics, rapid diagnostics for infectious disease, and tests for substance abuse. OraSure’s segments include Diagnostics segment and Molecular Collection Systems segment. The Diagnostics business primarily consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices. The Molecular Solutions business consists of the manufacture and sale of kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing in the consumer genetic, clinical genetic, academic research, infectious disease diagnostics, pharmacogenomics, personalized medicine, microbiome and animal genetics markets.


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OraSure Technologies Reports 2Q21 Revenue of $57.6 Million Driven by Strong Rebound in Core Business

4:05 pm ET August 3, 2021 (Globe Newswire) Print

-- 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."

Financial Highlights

Recent Business Highlights

COVID-19 Testing

Infectious Disease and Risk Assessment Testing

Molecular Solutions

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
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        %
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
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

Conference Call

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.

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:
Scott Gleason                                     Amy Koch
SVP Investor Relations & Corporate Communications Sr. Mgr. Corporate Communications
484-425-0588                                      484-523-1815
sgleason@orasure.com                              media@orasure.com



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