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OraSure Technologies (OSUR) Investor Presentation - Slideshow
2021-03-07 14:13
OraSure Technologies INVESTOR PRESENTATION MARCH 2021 DNAgenoTeK" % Diversigen" novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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 ...
OraSure Technologies(OSUR) - 2020 Q4 - Earnings Call Presentation
2021-03-03 20:11
OraSure Technologies INVESTOR PRESENTATION MARCH 2021 DNAgenoTeK" % Diversigen" novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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 ...
OraSure Technologies(OSUR) - 2020 Q4 - Earnings Call Transcript
2021-03-02 02:31
Financial Data and Key Metrics Changes - In Q4 2020, net revenues increased by 27% to $62.9 million from $49.7 million in Q4 2019, primarily due to strong sales of COVID-19 molecular sample collection kits and increased international sales of HIV self-tests [30][31] - Net product and services revenues were $60.4 million, a 28% increase from Q4 2019 [31] - Gross profit percentage improved to 61% in Q4 2020 from 60% in Q4 2019 due to a better product mix [32] - Net income for Q4 2020 was $1.9 million or $0.03 per share, compared to $2.4 million or $0.04 per share in Q4 2019 [33] Business Line Data and Key Metrics Changes - The molecular business unit generated $40.3 million in revenues during Q4 2020, a 58% increase from Q4 2019, driven by $22.5 million in sales of COVID-19 molecular testing kits [31] - International sales of OraQuick HIV tests increased by 16% compared to Q4 2019, largely due to higher sales in Africa [32][39] - Total diagnostic revenues decreased by 7% in Q4 2020 compared to Q4 2019, but the HIV self-test segment showed resilience with a 16% growth [40][78] Market Data and Key Metrics Changes - The company expects the demand for COVID-19 testing to remain strong, with the Biden administration proposing $50 billion in spending to increase testing capacity [10][29] - The global need for testing is projected to be significant, especially with the emergence of new variants of the virus [11][12] - The company is focusing on expanding its market presence in both high-income and low-middle-income countries for COVID-19 testing [88] Company Strategy and Development Direction - The company is advancing three distinct COVID-19 testing opportunities: molecular testing, rapid antigen self-tests, and lab-based oral fluid antibody tests [13][22] - Plans to submit for Emergency Use Authorization (EUA) for both prescription and professional self-tests by the end of the month [8][20] - The company aims to leverage its strong balance sheet to pursue transformative business development opportunities while maximizing COVID-19 market potential [47][116] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the resilience of legacy businesses and the ongoing recovery in non-COVID segments [81] - The company anticipates continued growth in COVID-19 molecular revenues into 2021 and expects to emerge from the pandemic as a larger and more innovative entity [46][48] - Management highlighted the importance of testing as a key part of disease management even as vaccination efforts progress [12][29] Other Important Information - Cash and investments totaled $257.1 million at the end of 2020, providing a strong financial position for future growth [34] - The company is expanding manufacturing capacity to support the production of 120 million rapid antigen self-tests annually by Q2 2022 [27] Q&A Session Summary Question: Can you comment on the performance of the antigen test versus other at-home tests? - Management confirmed substantial progress and emphasized the simplicity of their test as a key advantage, with confidence in meeting FDA requirements [52][53] Question: What is the expected demand for antigen tests? - Management indicated strong expressions of interest from potential customers, although demand is not locked in until EUA approval is obtained [54][56] Question: Can you provide guidance on Q1 revenue expectations? - Management expects sequential growth in COVID-19 molecular collection devices but did not provide detailed guidance beyond Q1 due to regulatory uncertainties [62][63] Question: What is the timeline for international market access? - Management is focusing on higher-income countries first, with plans to expand to lower-middle-income countries later in the year [88] Question: How does the company view the opportunity for home testing? - Management sees significant potential in effortless diagnostics and plans to explore new opportunities in this area [102][104] Question: What is the status of the antibody test EUA submission? - Management is working on the necessary studies and aims to submit the EUA as soon as possible [106] Question: How does the company view its relationship with a major genomics customer going public? - Management remains optimistic about the relationship and sees it as a strong strategic partnership moving forward [109]
OraSure Technologies(OSUR) - 2020 Q4 - Annual Report
2021-03-01 21:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-16537 ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 36-4370966 (State or Other Jurisdiction ...
OraSure Technologies(OSUR) - 2020 Q3 - Earnings Call Transcript
2020-11-05 01:58
OraSure Technologies, Inc. (NASDAQ:OSUR) Q3 2020 Earnings Conference Call November 4, 2020 5:00 PM ET Company Participants Jeanne Mell - Vice President of Corporate Communications Stephen Tang - President & Chief Executive Officer Roberto Cuca - Chief Financial Officer Conference Call Participants Vijay Kumar - Evercore ISI Frank Takkinen - Lake Street Capital Casey Woodring - JPMorgan Andrew Cooper - Raymond James Patrick Donnelly - Citigroup Jacob Johnson - Stephens Operator Good afternoon, everyone, and ...
OraSure Technologies (OSUR) Investor Presentation - Slideshow
2020-09-10 18:35
OraSure Technologies INVESTOR PRESENTATION SEPTEMBER 2020 DNAgenoтeк" & Diversigen' novosanis UrSure Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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 inclu ...
OraSure Technologies(OSUR) - 2020 Q2 - Earnings Call Transcript
2020-08-06 19:41
Financial Data and Key Metrics Changes - Net product and service revenues for Q2 2020 decreased by 24% compared to Q2 2019, primarily due to lower sales in genomics products and domestic HIV, HCV, and microbiome products impacted by COVID-19 [28][32] - Total product and service revenues for the DNA Genotek business unit were $18.1 million in Q2 2020, representing a 4% increase from Q2 2019 [30] - COVID-19 related revenues from molecular collection products reached $8.5 million in Q2 2020, contributing to expectations of higher total revenues in 2020 compared to 2019 [24][34] Business Line Data and Key Metrics Changes - International sales of OraQuick HIV products decreased by 28% compared to Q2 2019, attributed to shipment delays, although the underlying business showed strong year-to-date growth [29] - Laboratory service revenue increased to $2.2 million in Q2 2020 from $1.2 million in Q2 2019, driven by the performance of laboratory services subsidiaries [31] - The company expects non-COVID-19 revenues in infectious disease and molecular collections to decline in 2020, but COVID-19 product sales are anticipated to offset this decline [32][34] Market Data and Key Metrics Changes - The company is positioned to meet the global testing needs created by the COVID-19 pandemic, with existing distribution channels across public health, laboratories, and direct-to-consumer markets [8][12] - The demand for saliva collection devices is increasing as in-clinic blood collection remains challenging due to COVID-19 [47] - The company is exploring partnerships to expand its capacity to meet anticipated demands across all areas [41] Company Strategy and Development Direction - The company is focusing on expanding its COVID-19 testing capabilities, including antigen and antibody tests, to capture significant revenue opportunities [5][6] - Investments are being made to increase manufacturing capacity for COVID-19 related products, with expectations to ramp up production significantly in the coming quarters [36][39] - The acquisition of UrSure, Inc. supports the strategy of expanding the core offerings to include additional diagnostic products, particularly in the HIV space [45] Management's Comments on Operating Environment and Future Outlook - Management believes the second half of 2020 will show strong revenue growth, driven by COVID-19 related products and a recovery in non-COVID-19 business lines [6][34] - The company is optimistic about the long-term need for expanded testing options, even with the potential availability of vaccines [14][21] - Management highlighted the importance of rapid testing solutions for schools and workplaces as part of the strategy to support safe reopening [75] Other Important Information - The company ended Q2 2020 with $265.8 million in cash and no debt, positioning itself well for future growth [41] - The company is currently in clinical trials for its antigen test, with a target launch in Q4 2020 [59][60] - The company is also developing an ELISA test for COVID-19 antibodies, with plans to file for EUA in Q4 2020 [21] Q&A Session Summary Question: Can you elaborate on the switch to nostril collection for the antigen test? - The decision was based on scientific findings indicating that nasal swabs provide higher accuracy and viral load compared to oral fluid tests [58] Question: What are the expected milestones for the antigen test before the Q4 launch? - The next internal milestone is a prototype block, with the expectation of submitting for EUA in Q4 [59] Question: What end markets are being targeted for the antigen test? - The company is in discussions with large employers, schools, and government agencies for potential contracts [61][63] Question: Did the company recognize any revenues from CRL in Q2? - Specific customer contributions to revenue are not disclosed, but there is optimism for the second half of the year [70] Question: How does the recent FDA guidance impact the rapid test? - The company does not foresee any surprises in the FDA guidelines and believes it aligns with their product strategy [71] Question: What is the expected revenue visibility for the third quarter? - The company expects revenues to be substantially greater than the $8.5 million achieved in Q2, but specific numbers are not provided due to unpredictability [76]
OraSure Technologies (OSUR) Investor Presentation - Slideshow
2020-07-06 18:09
OraSure Technologies INVESTOR PRESENTATION JULY 2020 DNAgenoTeK" % Diversigen" novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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 ...
OraSure Technologies(OSUR) - 2020 Q1 - Earnings Call Transcript
2020-05-07 09:24
Financial Data and Key Metrics Changes - Net revenues for Q1 2020 were $31.6 million, a 5% increase from $30.1 million in Q1 2019. Excluding the cryosurgical product line sold in 2019 and including Diversigen's contribution, revenues grew 8% [17][22] - The net loss for Q1 2020 was $7.3 million or $0.12 per share, compared to a net loss of $3.3 million or $0.05 per share in Q1 2019 [29] - Cash balances at the end of Q1 2020 totaled $176 million, providing a strong liquidity position to navigate uncertainties [21][30] Business Line Data and Key Metrics Changes - International HIV sales increased 74% to $6.9 million, driven by strong demand for HIV Self-Tests [18][23] - Domestic HIV sales decreased 2% to $4.2 million due to COVID-19 impacts on public health testing [23] - Domestic HCV sales decreased 18% to $1.5 million, while international HCV sales decreased 25% to $1.1 million [24] - Molecular revenues increased 16% to $13.8 million, with genomic product revenues growing 14% to $9.1 million [25][46] Market Data and Key Metrics Changes - The COVID-19 pandemic has caused delays in HIV and HCV testing programs, impacting domestic sales [13][24] - Increased sales of In-Home HIV tests were noted as public health strategies adapted to COVID-19 [14][38] - The molecular solutions segment saw a 25% revenue increase, attributed to a shift from blood to saliva collection due to COVID-19 [46][50] Company Strategy and Development Direction - The company is focusing on developing COVID-19 testing products, including a pan-SARS coronavirus rapid antigen in-home self-test and an oral fluid microplate test for antibodies [9][41][44] - The strategy includes leveraging existing capabilities in infectious disease diagnostics to address COVID-19 testing needs [8][64] - The company is exploring collaborations to expand production capacity and meet high demand for COVID-19 products [45][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledged mixed impacts from COVID-19, with some revenue pressures but also new opportunities arising from increased demand for testing [11][31] - The company remains optimistic about the growth of its HIV Self-Testing business and the potential for new COVID-19 products to drive future revenues [64][65] - The management has withdrawn financial guidance for 2020 due to uncertainties related to the pandemic [31] Other Important Information - The company has implemented enhanced hygiene and social distancing protocols to ensure employee safety during the pandemic [12] - A significant organizational change was announced, with a new leader for the infectious disease business unit set to join [59][60] - The company is integrating its microbiome laboratory businesses and relocating to a new facility to enhance operational efficiency [57][58] Q&A Session Summary Question: Sensitivity and specificity of the rapid test - Management indicated a history of achieving high sensitivity and specificity in their product portfolio, with ongoing development for the new rapid test [68][69] Question: Pricing strategy for the home test - Management noted that pricing strategies are still under consideration and will be informed by their experience in the HIV market [72][73] Question: Manufacturing capacity for tests - Management discussed the need for significant capacity increases to meet potential demand for COVID-19 tests, with current production capabilities in the tens of millions of tests per year [74][75] Question: COVID-19 situation in sub-Saharan Africa - Management highlighted the importance of continuing HIV testing in Africa amidst COVID-19 and the potential for synergies in sales channels for both HIV and COVID-19 tests [78][81] Question: Future positioning of the company - Management expressed a vision of evolving into a broader infectious disease company, leveraging learnings from COVID-19 to address future public health needs [82][85] Question: Overall outlook considering COVID-19 impacts - Management sees more strength in tailwinds than headwinds, with optimism about the growth of the COVID-19 related business despite some negative impacts [88][89]
OraSure Technologies(OSUR) - 2019 Q4 - Earnings Call Transcript
2020-02-20 04:15
OraSure Technologies, Inc. (NASDAQ:OSUR) Q4 2019 Earnings Conference Call February 19, 2020 5:00 PM ET Company Participants Stephen Tang - President, CEO & Director Roberto Cuca - CFO & Principal Accounting Officer Conference Call Participants John Hsu - Raymond James & Associates Brandon Couillard - Jefferies Operator Good afternoon, everyone, and welcome to the OraSure Technologies 2019 Fourth Quarter Financial Results Conference call and Simultaneous Webcast. As a reminder, today's conference is being re ...