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New words:
AB, absent, Accordion, adjourn, adjourned, admission, admitted, advice, alia, amicable, analyst, Anatomical, Angelico, anniversary, anonyme, ArcherDX, argued, assumption, attendance, baby, Bachelor, background, Baxter, Bayshore, Beckman, Behring, Biology, Bioscience, Biosynex, Blackstone, BMC, bought, calibrated, car, Caso, CereVasc, Chemistry, Chen, Chiltern, COBRA, College, comfort, contended, Coulter, County, creation, Cyclica, Cytyc, Dade, Danaher, Daniel, deadline, deficiency, deficient, Delaware, desist, deter, deviate, disinterested, dispute, disputed, Doctor, Dover, duty, EBITDA, Elligo, energy, enjoined, entail, entirety, ERC, escrow, expenditure, Explanation, fabric, factual, Fellow, Fisher, float, foodborne, foot, format, formulaic, forty, forward, frame, French, Graduate, Hampshire, hematology, hoc, holder, Hologic, hub, immunological, inconsistent, Indiana, indirect, inducement, ineffective, instalment, Instruction, inter, interalia, Invitae, joining, joint, Katz, Keller, Leavitt, Leslie, lift, lifting, likewise, literate, lump, Lund, mandate, Marco, Master, maximum, median, mediation, mediator, memorandum, Merci, merged, merger, Meridian, metric, Meyer, Michelle, MINE, mirror, misconduct, Monday, moot, mooted, mortgage, NEO, neurological, neutral, nonqualified, nonrenewal, North, Nutrition, Onyx, opportunity, organizational, OTIP, overachievement, overseeing, Owner, par, Parent, Pathology, Pearl, peer, penalty, Pennsylvania, penny, Philosophy, Pittsburgh, POC, Polytechnic, Pool, power, Professor, progressing, PSLRA, Psychology, questionnaire, rata, recipient, reconsideration, regain, regained, reject, rejecting, relocation, reorganization, restraint, revisiting, Roche, Rock, role, Royal, RSA, RSU, SA, SCAC, School, se, secondary, seller, settle, settled, settling, Sholom, Sixty, Society, software, Solicitation, soliciting, solid, solidify, Southern, Specialty, spouse, standing, stemming, Suffolk, suggesting, Supreme, Surgery, surgical, surviving, Sweden, Tanistry, testimonial, Theorem, Thermo, thirteen, Tier, tool, Treasurer, unaffiliated, unanimously, undermine, unexercised, University, UNRESOLVED, unvested, upside, validly, virtue, voluntarily, vouching, Webster, welfare, whistleblower, withholding, Worcester
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Affordable, appointed, assuring, CFR, closed, Congenital, deducting, deliverable, diligence, documentary, estimating, franchise, GmbH, infant, intraperiod, Ireland, leaving, measure, methodology, mortality, MTCT, occurring, overallotment, perinatal, pregnant, prequalification, presently, pursuing, retrospectively, Simplifying, sweeping, transmission, undertaken, underwritten, unearned, unregistered, warrant, window, Workplace
Financial report summary
?Competition
Applied Dna SciencesRisks
- We may not complete the pending Merger with Biosynex SA and Project Merci Merger Sub, Inc. within the time frame we anticipate or at all, which could have an adverse effect on our business, financial results and operations.
- Our ability to complete the Merger is subject to certain closing conditions that could adversely affect us or cause the Merger to be abandoned.
- The pendency of the Merger with Biosynex and the Purchaser could adversely affect our business, financial results and operations.
- Stockholder litigation could prevent or delay the consummation of the Offer and the Merger or otherwise negatively impact our business, financial results and operations.
- If the Merger occurs, our stockholders will not be able to participate in any financial upside to our business after the Merger.
- We have incurred, and will continue to incur, direct and indirect costs as a result of the pending Merger.
- While the Merger Agreement is in effect, we are subject to restrictions on our business activities.
- The Merger Agreement limits our ability to pursue alternative transactions, which could deter a third party from proposing an alternative transaction.
- Our near term success is highly dependent on the success of the our DPP platform, and we cannot be certain that we will succeed in developing one or more of those systems or that, if we do, they will attain market acceptance or be successfully commercialized in the United States or elsewhere.
- We expect competition with respect to testing solutions for COVID-19 to continue to increase and our success will depend on market acceptance of our products.
- Some of our programs are supported by government grant awards, and our inability to obtain additional grant awards in the future or to derive all of the funding potentially available under those awards could delay our development and introduction of products.
- Initiating and completing clinical trials necessary to support a future EUA, 510(k), PMA, or de novo submission will be time consuming, expensive, and have an uncertain outcome. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any test kit we advance into clinical trials may not have favorable results in later clinical trials.
- We have been allocating a substantial portion of our resources to the development and commercialization of DPP SARS-CoV-2 Antigen test system, and our long term business success could be negatively impacted by our diversion of resources from our legacy business of diagnostic testing for other infectious diseases.
- The diagnostic testing market, particularly with respect to COVID-19, is highly competitive, and many of our competitors are larger, better established and have greater technical and marketing capabilities and financial and other resources than we have.
- Stockholder litigation could negatively impact our business, operating results and financial condition.
- We expect competition with respect to testing solutions for COVID-19 to continue to increase and our success will depend on market acceptance of our products.
- The COVID-19 pandemic could continue to affect our suppliers and employees, and cause disruptions in current and future plans for operations and expansion.
- We operate in a fragmented, segmented, and rapidly changing industry, which is highly competitive with respect to numerous factors, and our success depends on our ability compete effectively with larger companies, develop new or enhance existing products, as well as acceptance of DPP over other diagnostic platform technologies.
- Our competitors may develop and commercialize more effective or successful products, and our research, development and commercialization efforts may not succeed.
- Our products may not be able to compete with new diagnostic products or existing products developed by well-established competitors, which would negatively affect our business.
- Our future revenues and operating results may be negatively affected by ongoing consolidation in the healthcare industry.
- Our continued growth depends on retaining our current key employees and attracting additional qualified personnel, and we may not be able to do so.
- Third-party reimbursement policies and potential cost constraints could negatively affect our business.
- To the extent that we are unable to collect our outstanding accounts receivable, our operating results could be materially harmed.
- We believe our success depends in part on the continued funding of, and our ability to participate in, large testing programs in the United States and worldwide, the funding of which may be reduced or discontinued or otherwise be unavailable to us.
- Developing testing guidelines could negatively affect sales of our products.
- Our ability to efficiently operate our business is reliant on information technology, and any material failure, inadequacy, interruption or security breach of that technology could harm our business.
- If there is an increase in demand for our products, it could require us to expend considerable resources or harm our customer relationships if we are unable to meet that demand.
- Industry adoption of alternative technology to our COVID-19 Diagnostic Test Systems could negatively impact our ability to compete successfully.
- COVID-19 is prone to genetic mutations that may impact the ability of the COVID-19 Diagnostic Test Systems to adequately detect COVID-19, SARS-CoV-2 antigens and antibodies, and could adversely affect demand for the COVID-19 Diagnostic Test Systems and harm our competitive position.
- For our business to succeed in the future, our current and future products must receive market acceptance.
- We may not have sufficient resources to effectively introduce and market our products, which could materially harm our operating results.
- New developments in health treatments and non-diagnostic products may reduce or eliminate the demand for our products.
- Our future success will depend on our ability to cost-effectively increase manufacturing production capacity through the implementation of additional customized manufacturing automation equipment.
- Customer concentration creates risks for our business.
- Sales cycles for our products can be lengthy, which can cause variability and unpredictability in our business.
- We may face product liability claims for injuries.
- Our customers may not adopt rapid point-of-care diagnostic testing.
- If our products do not perform properly, it may affect our revenues, stock price and reputation.
- Because of our liquidity limitations, we have concluded there is a substantial doubt about our ability to continue as a going concern and we may require additional capital to fund our operations, which capital may not be available to us on acceptable terms or at all.
- Our failure to meet the minimum bid price for continued listing on The Nasdaq Capital Market could adversely affect our ability to publicly or privately sell equity securities and the liquidity of our common stock.
- Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.
- You may experience future dilution as a result of future equity offerings, exercises of outstanding options and vesting of options and restricted and performance stock units.
- We have incurred losses in recent years and we are uncertain about our future profitability and cash flow.
- Our financial results may fluctuate.
- The failure to comply with the terms of the Credit Agreement could result in a default under its terms and, if uncured, could result in action against our pledged assets and dilution of our stockholders.
- Servicing our debt will require a significant amount of cash. Our ability to generate sufficient cash to service our debt depends on many factors beyond our control.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- The LIBOR calculation method may change, and LIBOR is expected to be phased out, which may adversely affect our interest expenses under the Credit Agreement.
- Our operating results may be negatively affected by changes in foreign currency exchange rates.
- We operate in countries where there is or may be widespread corruption.
- We base our estimates or judgments relating to critical accounting policies on assumptions that can change or prove to be incorrect.
- Our success depends on our ability to protect our proprietary technology. We rely on trade secret laws and agreements with our key employees and other third parties to protect our proprietary rights, and we cannot be sure that these laws or agreements will adequately protect our rights.
- Any future intellectual property disputes could require significant resource and limit or eliminate our ability to sell products or use certain technologies.
- Our use of third-party suppliers, some of which may constitute our sole supply source, for certain important product components and materials presents risks that could have negative consequences for our business.
- Our ability to grow our business will be limited if we fail to maintain existing distribution channels or develop new distribution channels.
- Our U.S. government contracts require compliance with numerous laws and increase our risk and liability.
- Our U.S. government contracts are subject to future funding and the government’s choice to exercise options, and may be terminated at the government’s convenience.
- COVID-19 diagnostic tests, including the COVID-19 Diagnostic Test Systems, are subject to changes in CLIA, FDA, ANVISA and other regulatory requirements.
- We are subject to governmental export controls that could impair our ability to compete in international markets.
- Because we may not be able to obtain or maintain the necessary regulatory approvals for some of our products, we may not generate revenues in the amounts we expect, or in the amounts necessary to continue our business. Our existing products as well as our manufacturing facility must meet quality standards and are subject to inspection by a number of domestic regulatory and other governmental and non-governmental agencies.
- If we do not comply with FDA or other regulatory requirements, we may be required to suspend production or sale of our products or institute a recall, which could result in higher costs and a loss of revenues.
- Our inability to respond to changes in regulatory requirements could adversely affect our business.
- Demand for our products may be affected by FDA regulation of laboratory developed tests.
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared, approved, authorized, or commercialized in a timely manner or at all, which could negatively impact our business.
- In addition to FDA requirements, we are subject to numerous other federal, state and foreign government regulations, compliance with which could increase our costs and affect our operations.
- Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition.
- We may incur additional costs if we do not comply with privacy, security and breach notification regulations.
- Failure to comply with E.U. and U.K. data protection requirements could increase our costs.
- If we are not able to manufacture products in accordance with applicable requirements, it could adversely affect our business.
- Healthcare fraud and abuse laws could adversely affect our business and results of operations.
- If we expand our international presence, it may increase our risks and expose our business to regulatory, cultural or other challenges.
- Our common stock may have limited liquidity, and investors may not be able to sell as much common stock as they want at prevailing market prices or at all.
- Our common stock may become the target of a “short squeeze.”
- You may experience future dilution as a result of future equity offerings, exercises of outstanding options and vesting of options and restricted and performance stock units.
- Management will have broad discretion as to the use of any net proceeds of the offering made pursuant to the ATM Agreement, and we may in the future not use those net proceeds effectively.
- Sales of our common stock by existing stockholders, executive officers or directors could depress the market price of our common stock.
- We do not intend to pay cash dividends on our common stock.
- We may not generate the expected benefits of future strategic transactions or investments, and they could disrupt our ongoing business, distract our management, increase our expenses and negatively affect our business.
- Our compliance with regulations governing public companies is complex and expensive.
- Our business may be negatively affected by terrorist attacks or natural disasters.