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New words:
adjacent, aforementioned, al, alongside, amplify, arthropathy, assumption, behavior, biochemical, Birk, break, Brian, bridge, Chaim, clearer, CODM, compliant, contrast, CPPA, crystal, culmination, CY, cybersecurity, CYs, delegating, derecognized, DEX, Dinse, displace, dollar, elevated, email, Facebook, fewer, fifty, Florida, Fulgent, gap, geared, Geiger, gradual, hardware, harmonize, harmonized, humanitarian, hurricane, impartial, incapable, Indiana, internet, intrusion, Iowa, JHU, Kim, maker, Maximilian, Middle, Mindera, Montana, motion, Mountain, move, ninety, NIST, Nutrition, OCR, Oregon, oversee, paradigm, Parliament, Paul, percent, perpetrated, phishing, platform, prejudice, prime, proteomic, Putterman, reactive, reconciling, Registry, Relatedly, remittance, RSU, seronegative, session, Sjogren, speaker, spondyloarthropathy, stakeholder, stratifying, subgroup, subsided, TD, Tennessee, thirty, threat, TIgG, TIgM, triage, Tyler, unintentional, unlawfully, unsealed, upcoming, vastly, vigorously, withholding
Removed:
Accountability, activism, amortize, annum, antinuclear, AU, Australia, backbone, baseline, Biden, Biotech, Blair, Budget, Canada, Cantor, capillary, chromatographic, clarify, combine, compare, continuum, cooperate, damaging, deadly, drew, dried, establishment, exercising, expired, Fitzgerald, incorporating, inhibitor, intention, investor, ischemic, Janssen, JP, kinase, lapsed, larger, lender, literature, LLP, magnitude, medium, nanomolar, NYDOH, occasionally, owing, partnership, Portability, practical, predetermined, prepay, promptly, proportion, psoriatic, recognizing, remeasurement, replaced, restating, returning, satisfying, SIMPONI, spectrometry, split, steering, strike, stroke, sublicensed, subsidiary, tandem, Taxpayer, thrombotic, tiered, touch, transforming, unconditional, underwriting, updated, venipuncture, weekly, William
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • AMGEN • Myriad Genetics • Quest Diagnostics • Sanofi • Dxterity Diagnostics • Abbvie • Scipher MedicineRisks
- Risks Related to Our Business and Strategy
- We have a history of losses, we expect to incur net losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
- If third-party payors do not provide coverage and adequate reimbursement for our testing products, or they breach, rescind or modify their contracts or reimbursement policies or delay payments for our testing products, or if we or our partners are unable to successfully negotiate payor contracts, our commercial success could be compromised.
- In the near-term, we expect that our financial results will depend primarily on sales of our testing products, and we will need to generate sufficient revenue from these testing products to grow our business.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
- We may be unable to manage our growth effectively, which could make it difficult to execute our business strategy.
- Our commercial success depends upon attaining and maintaining significant market acceptance of our testing products among rheumatologists, patients, third-party payors and others in the medical community.
- We may experience limits on our revenue if rheumatologists decide not to order our testing products or if we are otherwise unable to create or maintain demand for our testing products.
- The sizes of the markets for our testing products have not been established with precision and may be smaller than we estimate.
- We may expend our limited resources to pursue a particular testing product and fail to capitalize on other testing products that may be more profitable or for which there is a greater likelihood of success.
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- We rely on sole suppliers for some of the reagents, equipment and other materials used in our testing products, and a sole third-party fulfillment center used to supply healthcare providers with our testing products, and we may not be able to find replacements or transition to alternative suppliers or fulfillment centers.
- If we are unable to support demand for our current testing products or any of our future testing products or solutions, our business could suffer.
- Billing for our testing products is complex, and we must dedicate substantial time and resources to the billing process to be paid for our testing products.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- If we are unable to maintain or expand our sales and marketing force, as needed, to adequately address our customers’ and future partners’ needs, our business may be adversely affected.
- If we are unable to compete successfully, we may be unable to increase or sustain our revenue or achieve profitability.
- Developing new testing products involves a lengthy and complex process, and we may not be able to commercialize on a timely basis, or at all, other testing products we are developing.
- If we cannot enter into new clinical study collaborations, our product development and subsequent commercialization could be delayed.
- We may acquire businesses or assets, form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
- The diagnostic industry is subject to rapidly changing technology, which could make our current and future testing products obsolete.
- Our failure to maintain relationships or build new relationships with key opinion leaders could materially adversely impact our business and prospects.
- If we are sued for errors and omissions or professional liability, we could face substantial liabilities that exceed our resources.
- The loss of members of our senior management team or our inability to attract and retain highly skilled scientists, technicians and salespeople could adversely affect our business.
- If our sole clinical laboratory facility becomes damaged or inoperable, we are required to vacate our existing facility or we are unable to expand our existing facility as needed, we will be unable to perform our testing services and our business will be harmed.
- Our testing process involves the use of sophisticated state-of-the-art equipment that requires precise calibration, and issues affecting such equipment may delay delivery or impact the quality of the test results to rheumatologists or otherwise adversely affect our operations.
- Failure in our information technology, telephone or other systems could significantly disrupt our operations and adversely affect our business and financial condition.
- Security breaches, loss of data and other disruptions to us, our third-party service providers or our partners could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
- Our financial condition, commercialization efforts and results of operations has been and may again in the future be adversely affected by outbreaks of contagious diseases.
- Performance issues, service interruptions or price increases by our shipping carrier could adversely affect our business, results of operations and financial condition, and harm our reputation and ability to provide testing services on a timely basis.
- Inflation could adversely affect our business and financial results.
- The failure of financial institutions or transactional counterparties could adversely affect our current and projected business operations and our financial condition and results of operations.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Our term loan contains restrictions that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.
- We may require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our product development programs, commercialization efforts or other operations.
- We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
- Healthcare policy changes, including recently enacted and proposed new legislation reforming the U.S. healthcare system, could cause significant harm to our business, operations and financial condition.
- Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
- We conduct business in a heavily regulated industry. Complying with the numerous statutes and regulations pertaining to our business is expensive and time-consuming, and any failure by us, our consultants or commercial partners to comply could result in substantial penalties.
- If we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
- We have previously and may again in the future be required to modify our business practices, pay fines, incur significant expenses or experience losses due to litigation or governmental investigations.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- The FDA may finalize its rulemaking to regulate LDTs or Congress may take action to reform the current legal requirements applicable to LDTs, and in either case, we may become subject to extensive regulatory requirements and may be required to conduct additional clinical trials prior to continuing to sell our existing tests or launching any other tests we may develop, which may increase the cost of conducting, or otherwise harm, our business.
- The FTC and/or state enforcement or regulatory agencies may object to the methods and materials we use to promote our tests and initiate enforcement against us, which could adversely affect our business and financial condition.
- Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Risks Related to our Intellectual Property
- If we are unable to maintain intellectual property protection, our competitive position could be harmed.
- Certain of our testing products utilize unpatented technology that is publicly available and can be used by our competitors.
- Some of our intellectual property has been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.
- We may not be able to protect our intellectual property rights throughout the world.
- The patent protection and patent prosecution for some of our testing products may be dependent on third parties.
- If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
- Third-party claims alleging intellectual property infringement may prevent or delay our development efforts.
- We may be involved in proceedings to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
- Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- Risks Related to Our Common Stock
- Our stock price may be volatile, and you may not be able to sell shares of our common stock at or above the price you paid.
- Future sales of shares by existing stockholders could cause our stock price to decline.
- Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which
- could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval.
- We have never paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future. Your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
- An active, liquid trading market for our common stock may not be maintained.
- Our failure to meet the continued listing requirements of Nasdaq or The Nasdaq Stock Market LLC could result in a delisting of our common stock.
- If securities or industry analysts downgrade our common stock or otherwise issue adverse opinions or commentary regarding our stock or do not publish research or reports about our company, our stock price and trading volume could decline.
- We could be subject to securities class action litigation.
Management Discussion
- Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
- You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and financial performance, includes forward-looking statements that are based on current beliefs, plans and expectations and involve risks, uncertainties and assumptions. You should read the "Special note regarding forward-looking statements" and "Risk Factors" section of this Annual Report on Form 10-K for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
- We exist to provide clarity in autoimmune disease decision making with the goal of improving patients' clinical outcomes. We have developed and are commercializing a portfolio of innovative testing products under our AVISE® brand, which allow for the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases. There is an unmet need for rheumatologists to add clarity in their CTD clinical evaluation, and we believe there is a significant opportunity for our tests in this market, particularly for potentially life-threatening diseases such as SLE.