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New words:
advisory, aware, backbone, Cardinal, clawback, Codification, complementary, compulsory, concurrent, contagion, Council, credibility, deadline, disaggregated, disaggregation, dynamic, Eastern, EI, eighty, electrical, field, formulating, freely, geopolitical, grandfathering, greatly, heading, hematologic, hundred, incident, mandatory, McKesson, meaningful, mentioned, misuse, misused, moderate, ninety, optimize, outsourcing, overtime, Parliament, Phase, plummet, PMA, premarketreview, prevalence, promptly, RDO, recapture, recoupment, reinstate, residing, Russia, sector, standing, strong, supplement, supplemented, suspected, ThermoFisher, thirteen, thirty, thousand, trial, turnover, Ukraine, unintended, user, vendor, viable, war
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adjusting, Aid, AML, automatically, bad, bid, closed, commerce, connectivity, consecutive, continuity, counterpart, cure, curve, default, diagnose, discount, doubtful, evidencing, executed, executing, formation, fundamental, hereof, leaving, letter, Lincoln, LP, month, notifying, observance, Oncometrix, pandemic, Paycheck, PLLC, POC, PPP, promissory, proportional, provisional, prudent, regain, setting, settled, specifically, spread, subsidiary, uncollectible, unsecured, view, Webster, worldwide, worsening
Financial report summary
?Competition
Qiagen • Quest Diagnostics • Neogenomics • Illumina • Cardiff Oncology • Guardant Health • NateraRisks
- There is substantial doubt about our ability to continue as a going concern.
- We have incurred losses since our inception and expect to incur losses for the foreseeable future. We cannot be certain that we will achieve or sustain profitability.
- We have been, and may continue to be, subject to costly litigation.
- The commercial success of our diagnostic products, including those we are developing, will depend upon the degree of market acceptance of these products among physicians, patients, health care payers and the medical community and on our ability to successfully market our products.
- If we cannot compete successfully with our competitors, including new entrants in the market, we may be unable to increase or sustain our revenue or achieve and sustain profitability.
- We may not be able to develop new products or enhance the capabilities of our systems to keep pace with rapidly changing technology and customer requirements, which could have a material adverse effect on our business and operating results.
- The sales of our products in the EU and the UK are regulated through a process that either requires self-certification or certification by a notified body in order to affix a CE mark. Such processes are uncertain, particularly in light of changes to the regulatory framework in the EU and UK. There may be a risk of delay in placing such products on the market and, once on the market, a risk of review and challenges to certain certified statuses.
- Global climate change could negatively affect our business.
- We depend upon a limited number of key personnel, and if we are not able to retain them or recruit additional qualified personnel, the execution of our strategy, management of our business and commercialization of our product candidates could be delayed or negatively impacted.
- We will need to increase the size of our organization, and we may experience difficulties in managing growth.
- We currently have limited experience in marketing products. If we are unable to establish marketing and sales capabilities and retain the proper talent to execute on our sales and marketing strategy, we may not be able to generate product revenue.
- Cybersecurity risks could compromise our information and expose us to liability, which may harm our ability to operate effectively and may cause our business and reputation to suffer.
- Our ability to use net operating loss carryforwards to offset future taxable income for U.S. federal tax purposes is subject to limitation and risk that could further limit our ability to utilize our net operating losses.
- Governmental payers and health care plans have taken steps to control costs, which could negatively affect our business.
- Changes in payer mix could have a material adverse impact on our net sales and profitability.
- Our laboratories require ongoing CLIA certification, and we cannot guarantee that our laboratories will pass all future certification inspections.
- Failure to comply with HIPAA could be costly.
- Our failure to comply with any applicable government laws and regulations or otherwise respond to claims relating to improper handling, storage or disposal of hazardous chemicals that we use may adversely affect our results of operations.
- We may become subject to the Anti-Kickback Statute, Stark Law, False Claims Act, Civil Monetary Penalties Law and may be subject to analogous provisions of applicable state laws and could face substantial penalties if we fail to comply with such laws.
- We cannot be certain that measures taken to protect our intellectual property will be effective.
- The price of our common stock may fluctuate significantly, which could negatively affect us and holders of our common stock.
- If we cannot continue to satisfy Nasdaq listing maintenance requirements and other rules, our securities may be delisted, which could negatively impact the price of our securities.
- Increased costs associated with corporate governance compliance may significantly impact our results of operations.
- We have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock for the foreseeable future. Any return on investment may be limited to the value of our common stock.
- If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
Management Discussion
- Net Change in Cash. Cash decreased by $1.9 million and $8.2 million during the years ended December 31, 2023 and 2022, respectively.
- Cash Flows Used in Operating Activities. The cash flows used in operating activities of $3.6 million during the year ended December 31, 2023 included a net loss of $5.8 million, an increase in accounts receivables of $0.5 million, a decrease in accounts payable of $0.2 million and a decrease in operating lease liabilities of $0.2 million. These were partially offset by a decrease in inventories of $0.3 million, a decrease in other assets of $0.4 million, an increase in accrued expenses of $0.7 million and non-cash adjustments of $1.7 million. The non-cash adjustments included $0.2 million for the change in provision for credit losses. We routinely provide a reserve for credit losses accounts as a result of having limited in-network payer contracts. The other non-cash adjustments to net loss of approximately $3.2 million include, among other things, depreciation and amortization, the value of stock issued in payment of services, gain on write-off of liabilities and stock-based compensation. The cash flows used in operating activities in the year ended December 31, 2022 included the net loss of $12.2 million, an increase in accounts receivables of $0.7 million, a decrease accrued expenses of $0.3 million, an increase in inventories of $0.1 million and a decrease in operating lease liabilities of $0.2 million. These were partially offset by a decrease in other assets of $0.5 million, an increase in accounts payable of $0.1 million, an increase in deferred revenue of $0.1 million and non-cash adjustments of $5.1 million.
- Cash Flows Used In Investing Activities. Cash flows used in investing activities were $0.1 million and $0.3 million for the years ended December 31, 2023 and 2022, respectively, resulting from purchases of property and equipment.