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Communication Services : Entertainment |
Company profile

InCapta, Inc. is a media holding company. The Company is focused on the radio, television, movie production and television productions to use on online Cloud television and radio. It is developing its online movie channel, a 24 hour a day streaming Internet television station, and its online news and video news bureau in association with Leading Edge Radio Network and Mancuso Martin Productions. The Company operates two cloud television networks: World Drone Recreation Aviators and Leading Edge Radio Network. Its network develops its own channel content. It is also involved in pre-production of two full-length movies; developing a weekly half hour television show; and producing radio talk show with LeadingEdgeRadio.com.

Closing Price
$0.0001
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0.00 (0.00%)
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0.0002
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0.0001
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(Light)
Volume:
5,520,151

10-day average volume:
26,185,466
5,520,151

OraSure Technologies, Inc. Announces Third Quarter 2020 Financial Results and Provides Update on COVID-19 Developments

4:01 pm ET November 4, 2020 (Globe Newswire) Print

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

COVID-19 Update

Molecular/PCR:

Antibody:

Antigen:

Manufacturing:

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.

Financial Data

                                                                     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  --      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

Conference Call

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.

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, 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. §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
orasure@argotpartners.com media@orasure.com

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