FOR OUR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
−Removed: February 25, 2021, our common stock was delisted from The Nasdaq Capital Market and was listed for trading on the OTCQX Best Market
−Removed: under the symbol “IDXG.”
+Added: February 25, 2021, our common stock was delisted from The Nasdaq Capital Market and began trading on the OTCQX Best Market under the
+Added: symbol “IDXG.” OTCQX Best Market quotations reflect inter-dealer prices and may not necessarily represent actual transactions.
January 15, 2020, we effected a one-for-ten reverse split of our issued and outstanding shares of our common stock.
At the effective
−Removed: time of the reverse split, every 10 shares of common stock issued and outstanding were automatically combined into one share of
−Removed: issued and outstanding common stock, without any change in the par value per share.
−Removed: Our common stock began trading on a reverse
−Removed: stock split-adjusted basis on January 15, 2020.
−Removed: had 194 stockholders of record as of March 12, 2021.
+Added: time of the reverse split, every 10 shares of common stock issued and outstanding were automatically combined into one share of issued
+Added: and outstanding common stock, without any change in the par value per share.
+Added: Our common stock began trading on a reverse stock split-adjusted
+Added: basis on January 15, 2020.
+Added: had 197 stockholders of record as of February 28, 2022.
Not reflected in the number of stockholders of record are persons who beneficially
1 unchanged sentence
have not declared any cash dividends and do not intend to declare or pay any cash dividends in the foreseeable future.
−Removed: earnings, if any, will be used to finance the future operation and growth of our businesses.
−Removed: FINANCIAL DATA
−Removed: are a “smaller reporting company”
−Removed: for purposes of the disclosure requirements of Item 301 of Regulation S-K and, therefore,
−Removed: we are not required to provide this information.
−Removed: MANAGEMENT’S
−Removed: DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction
−Removed: with our consolidated financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: discussion and analysis includes certain forward-looking statements that involve risks, uncertainties and assumptions.
−Removed: review the Risk Factors section of this Form 10-K for a discussion of important factors that could cause actual results to differ
−Removed: materially from the results described in or implied by such forward-looking statements.
−Removed: See Cautionary Note Regarding Forward-Looking
−Removed: Information at the beginning of this Form 10-K.
−Removed: are an emerging leader in enabling precision medicine principally in oncology by offering specialized services along the therapeutic
−Removed: value chain from early diagnosis and prognostic planning to targeted therapeutic applications through our clinical and pharma
−Removed: Through our clinical services, we enable physicians to personalize the clinical management of each individual patient
−Removed: by providing genomic information to better diagnose, monitor and inform cancer treatment.
−Removed: Our clinical services provide clinically
−Removed: useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest
−Removed: technology in personalized medicine for improved patient diagnosis and management.
−Removed: Through our pharma services, we develop, commercialize
−Removed: and provide molecular- and biomarker-based tests and services and provide companies with customized solutions for patient stratification
−Removed: and treatment selection through an extensive suite of molecular and biomarker-based testing services, DNA- and RNA- extraction
−Removed: and customized assay development and trial design consultation.
−Removed: Our pharma services provide pharmacogenomics testing, genotyping,
−Removed: biorepository and other specialized services to the pharmaceutical and biotech industries and advance personalized medicine by
−Removed: partnering with pharmaceutical, academic and technology leaders to effectively integrate pharmacogenomics into drug development
−Removed: and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: of COVID-19 pandemic
−Removed: have taken what we believe are necessary precautions to safeguard our employees from the COVID-19 pandemic.
−Removed: We continue to follow
−Removed: CDC guidance and the recommendations and restrictions provided by state and local authorities.
−Removed: The majority of our employees who
−Removed: do not work in a lab setting are currently able to successfully work remotely.
−Removed: Our labs require in-person staffing and we have
−Removed: been able to continue to operate our labs, minimizing infection risk to lab staff through a combination of social distancing and
−Removed: appropriate protective equipment.
−Removed: There can be no assurance, however, that key employees will not become ill or that we will able
−Removed: to continue to operate our labs successfully.
−Removed: second quarter Fiscal 2020 revenues were impacted by lower than expected clinical service volume which we believe resulted from
−Removed: the pandemic-related temporary reduction in non-essential testing procedures.
−Removed: Our pharma services business also softened during
−Removed: the second quarter of 2020.
−Removed: During the third and fourth quarters of 2020, our clinical services business recovered to levels prior
−Removed: to the pandemic and our pharma services business is was also recovering, but more slowly.
−Removed: continuing impact that the COVID-19 pandemic will have on our operations, including duration, severity and scope, remains highly
−Removed: uncertain and cannot be fully predicted at this time.
−Removed: Accordingly, we believe that the COVID-19 pandemic could continue to adversely
−Removed: impact our results of operations, cash flows and financial condition in the future.
−Removed: optimize the operations of laboratory operations within our pharma services, we transitioned activities from the Rutherford, NJ
−Removed: facility to our Morrisville, NC facility.
−Removed: We invested several million dollars to facilitate this relocation, including but not
−Removed: limited to the transfer of personnel, expansion of the Morrisville facility and validation of transferred processes over the next
−Removed: several months.
−Removed: We believe that this investment will result in a reduction in future operating costs;
−Removed: however, it is not certain
−Removed: whether we will successfully implement the relocation or whether the transition will produce the predicted financial benefits.
−Removed: of our laboratories are currently in operation and, in our view, are appropriately staffed for current volumes.
−Removed: While we do not
−Removed: anticipate any laboratory closures at this time beyond periodic, temporary work stoppages to clean and disinfect the labs, this
−Removed: could change in the future based upon conditions caused by the pandemic.
−Removed: Further, while we have acquired additional inventories
−Removed: of laboratory supplies, including reagents, it is possible that we could experience supply chain shortages if the pandemic continues
−Removed: for a prolonged period and/or if one or more suppliers is unable to continue to provide us with inventory.
−Removed: For the foreseeable
−Removed: future, however, we do not anticipate supply chain shortages of critical supplies or delays from our third-party clinical services
−Removed: billing and collections company.
−Removed: We continue to monitor the actual and potential impact of the pandemic upon our operations and
−Removed: will continue to do so.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: clinical services provide clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating cancer
−Removed: risk by leveraging the latest technology in personalized medicine for improved patient diagnosis and management.
−Removed: We develop and
−Removed: commercialize genomic tests and related first line assays principally focused on early detection of patients with indeterminate
−Removed: biopsies and at high risk of cancer using the latest technology to help personalized medicine and improve patient diagnosis and
−Removed: Our tests and services provide mutational analysis of genomic material contained in suspicious cysts, nodules and
−Removed: lesions with the goal of better informing treatment decisions in patients at risk of thyroid, pancreatic, and other cancers.
−Removed: laboratory developed molecular diagnostic tests we offer are designed to enable healthcare providers to better assess cancer risk,
−Removed: helping to avoid unnecessary surgical treatment in patients at low risk.
−Removed: We currently have five commercialized molecular
−Removed: diagnostic tests in the marketplace:
−Removed: PancraGEN ®
−Removed: , which is a pancreatic cyst and pancreaticobiliary solid lesion
−Removed: genomic test that helps PanDNA, a “molecular only”
−Removed: version of PancraGEN that provides physicians a snapshot of
−Removed: a limited number of factors;
−Removed: physicians better assess risk of pancreaticobiliary cancers using our proprietary PathFinderTG ®
−Removed: platform; ThyGeNEXT ®
−Removed: , which is an expanded oncogenic mutation panel that helps identify malignant thyroid
−Removed: nodules; ThyraMIR ®
−Removed: , which assesses thyroid nodules for risk of malignancy utilizing a proprietary microRNA
−Removed: gene expression assay;
−Removed: and RespriDx ®
−Removed: , which is a genomic test that helps physicians differentiate metastatic or
−Removed: recurrent lung cancer from the presence of newly formed primary lung cancer and which also utilizes our PathFinderTG ®
−Removed: platform to compare the genomic fingerprint of two or more sites of lung cancer.
−Removed: BarreGEN ®
−Removed: , an esophageal
−Removed: cancer risk classifier for Barrett’s Esophagus that also utilizes our PathFinder TG ®
−Removed: have a multicenter study underway to further assess the ability of BarreGEN ®
−Removed: to accurately predict progression
−Removed: to high grade dysplasia or cancer and to assist us in positioning our product for full launch, partnering, and potentially
−Removed: supporting reimbursement with payers.
−Removed: mission is to provide personalized medicine through genomics-based diagnostics and innovation to advance patient care based on
−Removed: rigorous science.
−Removed: Our laboratories are licensed pursuant to federal law under CLIA and are accredited by CAP and New York State.
−Removed: leverage our laboratories to develop and commercialize our assays and products.
−Removed: We aim to provide physicians and patients with
−Removed: diagnostic options for detecting genomic and other molecular alterations that are associated with gastrointestinal, endocrine,
−Removed: and lung cancers.
−Removed: Our customers consist primarily of physicians, hospitals and clinics.
−Removed: global molecular diagnostics market is estimated to be approximately $8.7 billion in 2020 and is a segment within the estimated
−Removed: $69.2 billion in vitro diagnostics market in 2019 according to statistics from Kalorama Information, publisher of the Worldwide
−Removed: Market for In Vitro Diagnostic Tests .
−Removed: believe that the molecular diagnostics market offers significant growth and strong patient value given the substantial opportunity
−Removed: it affords to lower healthcare costs by helping to reduce unnecessary surgeries and ensuring the appropriate frequency of monitoring.
−Removed: We are keenly focused on growing our test volumes, securing additional insurance coverage and reimbursement, maintaining and growing
−Removed: our current reimbursement and supporting revenue growth for our molecular diagnostic tests, introducing related first line product
−Removed: and service extensions, as well as expanding our business by developing and promoting synergistic products in our markets.
−Removed: also believe that BarreGEN ®
−Removed: is a potentially significant pipeline product, and we are providing necessary resources
−Removed: to accelerate our development process.
−Removed: Further, we believe BarreGEN ®
−Removed: is synergistic with our capabilities in the
−Removed: gastrointestinal market, which is one of the sectors in which we operate.
−Removed: pharma services provide pharmacogenomics testing, genotyping, biorepository and other specialized services to the pharmaceutical
−Removed: and biotech industries.
−Removed: Laboratory and testing services are performed for pharmaceutical and biotech companies engaged in clinical
−Removed: trials and focuses on providing these clients with oncology specific and non-oncology genetic testing services for phase I-IV
−Removed: clinical trials along with critical support of ancillary services.
−Removed: These services include:
−Removed: biorepository, clinical trial logistics,
−Removed: clinical trial design, bioinformatics analysis, customized assay development, DNA and RNA extraction and purification, genotyping,
−Removed: gene expression and biomarker analyses.
−Removed: We also seek to apply our expertise in laboratory developed tests to assist in developing
−Removed: and commercializing drug-specific companion diagnostics.
−Removed: We have established business relationships with key instrument manufacturers
−Removed: to support their platforms in the market, and to drive acceptance among biopharmaceutical sponsors developing innovative immuno-oncology
−Removed: and biomarker-based testing services have been altering the clinical trials landscape by providing biotech and pharmaceutical
−Removed: companies with information about trial subjects’
−Removed: genetic profiles that may be able to inform researchers whether or not
−Removed: a subject will benefit from the trial drug or will experience adverse effects.
−Removed: Streamlined subject selection and stratification,
−Removed: and tailored therapies selected to maximally benefit each group of subjects may increase the number of trials that result in approved
−Removed: therapies and make conducting clinical trials more efficient and less costly for biotech and pharmaceutical companies.
−Removed: 48 new drugs were approved by the FDA, and nearly a quarter of these drugs were oncology-focused, highlighting the potential value
−Removed: of incorporating genomic information into oncology clinical trial design.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: addition to the tests and services provided to our pharma customers, we custom develop Next Generation Sequencing (NGS) panels
−Removed: for our customers focused on pharmacogenomics and oncology.
−Removed: also utilize our laboratories to provide clinical trial services to the pharmaceutical and biotech industries to improve the efficiency
−Removed: and economic viability of clinical trials.
−Removed: Our clinical trials services leverage our knowledge of clinical oncology and molecular
−Removed: diagnostics and our laboratories’
−Removed: fully integrated capabilities.
−Removed: We believe our laboratory is one of a few with the capability
−Removed: to combine somatic and germline mutational analyses in clinical trials.
−Removed: We operate through a CLIA certificated and CAP accredited
−Removed: laboratory located in Raleigh, North Carolina.
−Removed: laboratory possesses capabilities in histology, immunohistochemistry (IHC), flow cytometry, cytogenetics and fluorescent in-situ
−Removed: hybridization (FISH), as well as sophisticated molecular analysis techniques, including next generation sequencing.
−Removed: for comprehensive customized testing within one lab enterprise, with our CAP-accredited biorepository laboratory serving as a
−Removed: central hub for specimen tracking.
−Removed: Using this approach, we are able to support demanding clinical trial protocols requiring multiple
−Removed: assays and techniques aimed at capturing data on multiple biomarkers.
−Removed: Our suite of available testing platforms allows for highly
−Removed: customized clinical trial design which is supported by our dedicated group of development scientists and technical personnel.
−Removed: also provide genetic testing for drug metabolism to aid biotech and pharmaceutical companies identify subjects’
−Removed: likely responses
−Removed: to treatment, allowing these companies to conduct more efficient and safer clinical trials.
−Removed: We believe pharmacogenomics drug metabolism
−Removed: testing helps deliver the promise of personalized medicine by enabling researchers to tailor therapies in development to differences
−Removed: in patients’
−Removed: genomic profiles.
−Removed: February 25, 2021, the Company’s common stock was delisted from The Nasdaq Stock Market LLC (“Nasdaq”) due
−Removed: to the Company’s failure to regain compliance with Nasdaq’s minimum $2,500,000 stockholders’
−Removed: equity requirement
−Removed: for continued listing as set forth in Nasdaq Listing Rule 5550(b) (the “Rule”) and the Company’s failure to
−Removed: timely execute its plan to regain compliance under the Rule.
−Removed: February 24, 2021, the Company was approved to have its common stock quoted on the OTCQX®
−Removed: Best Market tier of the OTC Markets
−Removed: (the “OTCQX”), an electronic quotation service operated by OTC Markets Group Inc.
−Removed: The trading of the Company’s
−Removed: common stock commenced on OTCQX at the open of business on February 25, 2021 under the trading symbol IDXG.
−Removed: OF REPORTING SEGMENTS
−Removed: operate under one segment which is the business of developing and selling diagnostic clinical and pharma services.
−Removed: ACCOUNTING POLICIES
−Removed: prepare our consolidated financial statements in accordance with U.S.
−Removed: generally accepted accounting principles, or (“GAAP”).
−Removed: The preparation of financial statements and related disclosures in conformity with GAAP requires management to make judgments,
−Removed: estimates and assumptions at a specific point in time that affect the amounts reported in our consolidated financial statements
−Removed: and disclosed in the accompanying notes.
−Removed: These assumptions and estimates are inherently uncertain.
−Removed: Outlined below are accounting
−Removed: policies, which are important to our financial position and results of operations and require our management to make significant
−Removed: judgments in their application.
−Removed: Some of those judgments can be subjective and complex.
−Removed: Management’s estimates are based
−Removed: on historical experience, information from third-party professionals, facts and circumstances available at the time and various
−Removed: other assumptions that are believed to be reasonable.
−Removed: Actual results could differ from those estimates.
−Removed: Additionally, changes
−Removed: in estimates could have a material impact on our consolidated results of operations in any one period.
−Removed: For a summary of all of
−Removed: our significant accounting policies, including the accounting policies discussed below, see Note 1, Nature of Business and
−Removed: Significant Accounting Policies , to our consolidated financial statements included in this Annual Report on Form 10-K.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: and Cost of Revenue
−Removed: Company’s revenue is primarily generated from the performance of its proprietary molecular diagnostic tests for its clinical
−Removed: customers and its DNA-based testing services in support of clinical trials for its pharma services customers.
−Removed: The Company’s
−Removed: performance obligation is fulfilled upon completion, review and release of test results and subsequent billing to the third-party
−Removed: payer, hospital or service provider, or biopharma companies.
−Removed: 606 Revenue Recognition
−Removed: services derive its revenues from the performance of its proprietary assays or tests.
−Removed: The Company’s performance obligation
−Removed: is fulfilled upon completion, review and release of test results to the customer.
−Removed: The Company subsequently bills third-party payers
−Removed: or direct-bill payers for the tests performed.
−Removed: Revenue is recognized based on the estimated transaction price or net realizable
−Removed: value (“NRV”), which is determined based on historical collection rates by each payer category for each proprietary
−Removed: test offered by the Company.
−Removed: To the extent the transaction price includes variable consideration, for all third party and direct-bill
−Removed: payers and proprietary tests, the Company estimates the amount of variable consideration that should be included in the transaction
−Removed: price using the expected value method based on historical experience.
−Removed: our clinical services, we regularly review the ultimate amounts received from the third-party and direct-bill payers and related
−Removed: estimated reimbursement rates and adjust the NRV’s and related contractual allowances accordingly.
−Removed: If actual collections
−Removed: and related NRV’s vary significantly from our estimates, we adjust the estimates of contractual allowances, which would
−Removed: affect net revenue in the period such variances become known.
−Removed: our pharma services customers, performance obligations are satisfied at a point in time as the Company processes samples delivered
−Removed: by the customer.
−Removed: Project level activities, including study setup and project management, are satisfied over the life of the contract.
−Removed: Revenues are recognized at a point in time when the test results or other deliverables are reported to the customer.
−Removed: our pharma services, project level fee revenue is recognized as deferred revenue and recorded at fair value.
−Removed: It represents payments
−Removed: received in advance of services rendered and is recognized ratably over the life of the contract.
−Removed: Company determines if an arrangement contains a lease in whole or in part at the inception of the contract.
−Removed: Right-of-use (“ROU”)
−Removed: assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our
−Removed: obligation to make lease payments arising from the lease.
−Removed: All leases with terms greater than twelve months result in the recognition
−Removed: of a ROU asset and a liability at the lease commencement date based on the present value of the lease payments over the lease
−Removed: Unless a lease provides all of the information required to determine the implicit interest rate, we use our incremental
−Removed: borrowing rate based on the information available at the commencement date in determining the present value of the lease payments.
−Removed: We use the implicit interest rate in the lease when readily determinable.
−Removed: lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
−Removed: certain that we will exercise that option.
−Removed: Leases with terms of twelve months or less at the commencement date are expensed on
−Removed: a straight-line basis over the lease term and do not result in the recognition of an asset or liability.
−Removed: See Note 9, Leases .
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: Assets, including Finite-Lived Intangible Assets
−Removed: review the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances
−Removed: indicate that the carrying value of such assets may not be recoverable.
−Removed: If the sum of the expected future undiscounted cash flows
−Removed: is less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to
−Removed: its fair value measured by future discounted cash flows.
−Removed: This analysis requires estimates of the amount and timing of projected
−Removed: cash flows and, where applicable, judgments associated with, among other factors, the appropriate discount rate.
−Removed: Such estimates
−Removed: are critical in determining whether any impairment charge should be recorded and the amount of such charge if an impairment loss
−Removed: is deemed to be necessary.
−Removed: a result of overall economic conditions related to the coronavirus pandemic, the impact of the coronavirus pandemic on the Company’s
−Removed: financial results, and the decrease in the price of the Company’s common stock noted during the third quarter of fiscal
−Removed: 2020, the Company performed an internal review of its long-lived assets.
−Removed: Due to an extended delay in the launch of the Company’s
−Removed: Barrett’s test, the Company believes there was a triggering event in Fiscal 2016.
−Removed: The Company applied the required procedures
−Removed: under ASC 360 and assessed the estimated future cash flows related to the Barrett’s intangible asset on an undiscounted
−Removed: It was determined that the carrying value of the asset was in excess of the undiscounted cash flows as of December 31,
−Removed: As a result, the Company performed a formal valuation of the asset on a discounted basis in order to measure the related
−Removed: Additionally, the Company concluded that amortization of both the Barrett’s intangible asset and its Thyroid
−Removed: intangible assets should have commenced upon acquisition of those assets as opposed to the Company’s previously disclosed
−Removed: policy of beginning asset amortization when the product was launched and generating revenue.
−Removed: Contingencies
−Removed: the normal course of business, we are subject to various contingencies.
−Removed: Contingencies are recorded in the consolidated financial
−Removed: statements when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated, or otherwise
−Removed: disclosed, in accordance with ASC 450, Contingencies.
−Removed: Significant judgment is required in both the determination of probability
−Removed: and the determination as to whether a loss is reasonably estimable.
−Removed: In the event we determine that a loss is not probable, but
−Removed: is reasonably possible, and it becomes possible to develop what we believe to be a reasonable range of possible loss, then we
−Removed: will include disclosures related to such matter as appropriate and in compliance with ASC 450.
−Removed: To the extent there is a reasonable
−Removed: possibility that the losses could exceed the amounts already accrued, we will, when applicable, adjust the accrual in the period
−Removed: the determination is made, disclose an estimate of the additional loss or range of loss, indicate that the estimate is immaterial
−Removed: with respect to its financial statements as a whole or, if the amount of such adjustment cannot be reasonably estimated, disclose
−Removed: that an estimate cannot be made.
−Removed: We are currently a party to legal proceedings that are incidental to our business.
−Removed: we have accrued our estimate of the probable costs for the resolution of these claims.
−Removed: These estimates are developed in consultation
−Removed: with outside counsel and are based upon an analysis of potential results, assuming a combination of litigation and settlement
−Removed: Predicting the outcome of claims and litigation, and estimating related costs and exposures, involves substantial
−Removed: uncertainties that could cause actual costs to vary materially from estimates.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: taxes are based on income for financial reporting purposes calculated using our expected annual effective rate and reflect a current
−Removed: tax liability or asset for the estimated taxes payable or recoverable on the current year tax return and expected annual changes
−Removed: in deferred taxes.
−Removed: account for income taxes using the asset and liability method.
−Removed: This method requires recognition of deferred tax assets and liabilities
−Removed: for expected future tax consequences of temporary differences that currently exist between tax bases and financial reporting bases
−Removed: of our assets and liabilities based on enacted tax laws and rates.
−Removed: Deferred tax expense (benefit) is the result of changes in
−Removed: the deferred tax asset and liability.
−Removed: A valuation allowance is established, when necessary, to reduce the deferred income tax
−Removed: assets when it is more likely than not that all or a portion of a deferred tax asset will not be realized.
−Removed: operate in multiple tax jurisdictions and provide taxes in each jurisdiction where we conduct business and are subject to taxation.
−Removed: The breadth of our operations and the complexity of the various tax laws require assessments of uncertainties and judgments in
−Removed: estimating the ultimate taxes we will pay.
−Removed: The final taxes paid are dependent upon many factors, including negotiations with taxing
−Removed: authorities in various jurisdictions, outcomes of tax litigation and resolution of proposed assessments arising from federal and
−Removed: state audits.
−Removed: We have established estimated liabilities for uncertain federal and state income tax positions.
−Removed: Uncertain tax positions
−Removed: are recognized in the financial statements when it is more likely than not (for example, a likelihood of more than fifty percent)
−Removed: that a position taken or expected to be taken in a tax return would be sustained upon examination by tax authorities that have
−Removed: full knowledge of all relevant information.
−Removed: A recognized tax position is then measured as the largest amount of benefit that is
−Removed: greater than fifty percent likely to be realized upon ultimate settlement.
−Removed: We adjust our accruals for unrecognized tax benefits
−Removed: as facts and circumstances change, such as the progress of a tax audit.
−Removed: We believe that any potential audit adjustments will not
−Removed: have a material adverse effect on our financial condition or liquidity.
−Removed: However, any adjustments made may be material to our consolidated
−Removed: results of operations or cash flows for a reporting period.
−Removed: Penalties and interest, if incurred, would be recorded as a component
−Removed: of current income tax expense.
−Removed: Management plans to commence filing tax clearance certificates in states and related tax jurisdictions
−Removed: in which un-recognized tax benefits attributable to its former operating entities are recorded as long-term liabilities on the
−Removed: accompanying balance sheet.
−Removed: This process can range from 6 to 18 months before the Company receives clearance as to balances, if
−Removed: any, it may owe to a particular state or tax jurisdiction.
−Removed: Upon receipt and acknowledgment from a state or tax jurisdiction, the
−Removed: Company will settle the remaining obligation or reverse the recorded amount owed during the period in which the tax clearance
−Removed: certificate is obtained.
−Removed: judgment is also required in evaluating the need for and magnitude of appropriate valuation allowances against deferred tax assets.
−Removed: We currently have significant deferred tax assets resulting from net operating loss carryforwards and deductible temporary differences.
−Removed: The realization of these assets is dependent on generating future taxable income.
−Removed: We perform an analysis quarterly to determine
−Removed: whether the expected future income will more likely than not be sufficient to realize the deferred tax assets.
−Removed: Our recent operating
−Removed: results and projections of future income weighed heavily in our overall assessment.
−Removed: The existing and forecasted levels of pretax
−Removed: earnings for financial reporting purposes are not sufficient to generate future taxable income and realize our deferred tax assets
−Removed: and, as a result, we established a full federal and state valuation allowance for the net deferred tax assets at December 31,
−Removed: 2020 and 2019, as we determined that it was more likely than not that these assets would not be realized.
−Removed: NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities.
−Removed: tax credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest
−Removed: of significant stockholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue
−Removed: Code of 1986, as amended, or the Code, as well as similar state tax provisions.
−Removed: The amount of the annual limitation, if any, will be
−Removed: determined based on the value of our company immediately prior to an ownership change.
−Removed: Subsequent ownership changes may further affect
−Removed: the limitation in future years.
−Removed: Additionally, U.S.
−Removed: tax laws limit the time during which these carry forwards may be applied against future
−Removed: taxes, therefore, we may not be able to take full advantage of these carry forwards for federal income tax purposes.
−Removed: It was determined
−Removed: that the Company underwent an ownership change and as a result, NOLs attributable to the pre-ownership change are subject to a substantial
−Removed: annual limitation under Section 382 of the Internal Revenue Code due to the ownership changes.
−Removed: The Company has adjusted their NOL carryforwards
−Removed: to address the impact of the 382 ownership change.
−Removed: Compensation Costs
−Removed: compensation cost associated with the granting of stock-based awards is based on the grant date fair value of the stock award.
−Removed: We recognize the compensation cost, net of estimated forfeitures, over the shorter of the vesting period or the period from the
−Removed: grant date to the date when retirement eligibility is achieved.
−Removed: Forfeitures are initially estimated based on historical information
−Removed: and subsequently updated over the life of the awards to ultimately reflect actual forfeitures.
−Removed: As a result, changes in forfeiture
−Removed: activity can influence the amount of stock compensation cost recognized from period-to-period.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: primarily use the Black-Scholes option pricing model to determine the fair value of stock options and stock-based stock appreciation
−Removed: rights (SARs).
−Removed: The determination of the fair value of stock-based payment awards is made on the date of grant and is affected
−Removed: by our stock price as well as assumptions made regarding a number of complex and subjective variables.
−Removed: These assumptions include:
−Removed: our expected stock price volatility over the term of the awards;
−Removed: actual and projected employee stock option exercise behaviors;
−Removed: the risk-free interest rate;
−Removed: and expected dividend yield.
−Removed: in the valuation assumptions could result in a significant change to the cost of an individual award.
−Removed: However, the total cost
−Removed: of an award is also a function of the number of awards granted, and as result, we have the ability to manage the cost and value
−Removed: of our equity awards by adjusting the number of awards granted.
−Removed: RESULTS OF OPERATIONS
−Removed: following table sets forth the selected statements of operations data ($ in thousands) as a percentage of revenue for the periods
−Removed: The trends illustrated in this table may not be indicative of future operating results.
−Removed: Ended December 31,
−Removed: Cost of revenue
−Removed: Operating expenses:
−Removed: Sales and marketing
−Removed: General and administrative
−Removed: Acquisition related
−Removed: Acquisition related
−Removed: amortization expense
−Removed: in fair value of contingent consideration
−Removed: operating expenses
−Removed: Operating loss
−Removed: Interest accretion expense
−Removed: (expense), net
−Removed: Loss from continuing
−Removed: operations before tax
−Removed: Benefit (provision)
−Removed: for income taxes
−Removed: Loss from continuing
−Removed: Loss from discontinued
−Removed: operations, net of tax
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: revenue for the year ended December 31, 2020 increased by $8.2 million, or 34%, to $32.4 million, compared to the year ended December
−Removed: This increase was primarily attributable to the full year of revenue from pharma services as compared to the partial
−Removed: year in 2019 and the accounts receivable adjustment we recorded in the fourth quarter of 2019 of $8.7 million, which was recorded
−Removed: as a reduction in net revenue (representing a change in estimate in accordance with ASC 606) due to third party collection issues,
−Removed: of which $3.5 million was related to billings in 2018 and $5.2 million related to billings in 2019.
−Removed: cost of revenue for the year ended December 31, 2020 increased by $5.8 million, or 36%, to $21.7 million,
−Removed: compared to the year ended December 31, 2019 primarily due to pharma services acquired in July 2019.
−Removed: gross profit for the year ended December 31, 2020 increased $2.4 million, or 29%, to $10.7 million, compared
−Removed: to $8.3 million for the year ended December 31, 2019.
−Removed: This increase was attributable to the $8.7 million revenue adjustment discussed
−Removed: above which was recorded in the fourth quarter of 2019.
−Removed: and marketing expense
−Removed: sales and marketing expense was $9.3 million for the year ended December 31, 2020, as compared to $11.1 million for the year ended
−Removed: December 31, 2019.
−Removed: As a percentage of revenue, sales and marketing expense decreased to 29% from 46% in the comparable prior year
−Removed: The decrease in sales and marketing expense primarily reflects the slowdown of sales activity for clinical services due
−Removed: to the COVID-19 pandemic.
−Removed: and development
−Removed: research and development expense was approximately $2.8 million in the periods ended December 31, 2020 and 2019, and as a percentage
−Removed: of revenue was 9% for the year ended December 31, 2020 and 12% for the year ended December 31, 2019.
−Removed: The decrease as a percentage
−Removed: of revenue was due to higher revenue in 2020.
−Removed: and administrative
−Removed: and administrative expense for the year ended December 31, 2020 was $20.8 million as compared to $14.4 million for the
−Removed: year ended December 31, 2019.
−Removed: The increase was primarily attributable to costs associated with the acquired pharma services.
−Removed: a percentage of net revenue, general and administrative expense was 64% for the year ended December 31, 2020 as compared to 59%
−Removed: for the year ended December 31, 2019.
−Removed: related expense
−Removed: the year ended December 31, 2019, we incurred approximately $2.5 million in external costs related to our acquisition of pharma
−Removed: services on July 15, 2019.
−Removed: related amortization expense
−Removed: the years ended December 31, 2020 and December 31, 2019, we recorded amortization expense of approximately $4.5 million and $4.0
−Removed: million, respectively, which is related to intangible assets associated with our acquisitions.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: in fair value of contingent consideration
−Removed: the year ended December 31, 2020, there was a $0.5 million decrease in the contingent consideration liability.
−Removed: During the year
−Removed: ended December 31, 2019, there was a $0.04 million decrease in the contingent consideration liability.
−Removed: were consolidated operating losses from continuing operations of $26.1 million and $26.4 million during the years ended
−Removed: December 31, 2020 and 2019, respectively.
−Removed: (benefit) for income taxes
−Removed: had income tax expense of $0.1 million for the year ended December 31, 2020 and an income tax benefit of $28,000 for the year
−Removed: ended December 31, 2019.
−Removed: Income tax expense for 2020 was primarily driven by minimum state and local taxes.
−Removed: from discontinued operations, before tax
−Removed: had a loss from discontinued operations of $0.3 million for the year ended December 31, 2020 as compared to a loss from
−Removed: discontinued operations of $0.1 million for the year ended December 31, 2019.
−Removed: AND CAPITAL RESOURCES
−Removed: the fiscal year ended December 31, 2020, we had an operating loss of $26.1 million.
−Removed: As of December 31, 2020, we had cash,
−Removed: cash equivalents and restricted cash of $3.4 million, total current assets of $14.1 million and current
−Removed: liabilities of $18.2 million.
−Removed: As of March 25, 2021, we had approximately $3.2 million of cash on hand,
−Removed: excluding restricted cash.
−Removed: the year ended December 31, 2020, net cash used in operating activities was $14.0 million.
−Removed: The main component of cash used
−Removed: in operating activities was our net loss of $26.5 million which was partially offset by non-cash expenses of $7.7
−Removed: During the year ended December 31, 2019, net cash used in operating activities was $19.0 million, all but $0.03 million
−Removed: of which was used in continuing operations.
−Removed: The main component of cash used in operating activities was our net loss of $26.7
−Removed: the year ended December 31, 2020, cash provided from financing activities was $16.6 million, $19.2 million which resulted
−Removed: from the issuance of preferred stock in January 2020 and $0.4 million from sales of Common Stock, partially offset by the repayment
−Removed: of $3.0 million of borrowed funds under our Revolver.
−Removed: For the year ended December 31, 2019, there was cash provided from financing
−Removed: activities of $29.2 million, $6.5 million of which resulted from the issuance of common stock in our underwritten public offering
−Removed: completed in January 2019, $25.7 million which resulted from the issuance of Preferred Stock in July and October 2019, and $3.0
−Removed: million from the drawing down of funds under our revolving line of credit with Silicon Valley Bank (“SVB”).
−Removed: partially offset by the payment of the note payable to Cancer Genetics of $6.0 million as part of the acquisition of the pharma
−Removed: services business in July 2019.
−Removed: the year ended December 31, 2020, cash used in investing activities was $1.6 million, primarily related to capital expenditures
−Removed: associated with the moving of our Rutherford, New Jersey lab to North Carolina.
−Removed: For the year ended December 31, 2019, there was
−Removed: cash used in investing activities of $13.9 million, $13.8 million of which was used in our acquisition of the pharma services
−Removed: September 2019, we entered into the Equity Distribution Agreement (the “Agreement”) with Oppenheimer & Co.
−Removed: as sales agent (the “Agent”), pursuant to which we, from time to time, issued and sold shares of our common stock
−Removed: in an aggregate offering price of up to $4.8 million through the Agent.
−Removed: See Note 13, Equity of the notes to the financial statements
−Removed: for more details.
−Removed: In 2020, approximately 178,000 shares were sold for net proceeds of approximately $0.4 million.
−Removed: In 2019, approximately
−Removed: 98,000 shares (as adjusted for the reverse stock split) of common stock were sold for net proceeds of approximately $0.2 million.
−Removed: Further, upon the filing of this Report, we will no longer remain eligible to use Form S-3 and therefore we will lose our ability
−Removed: to sell Shares under the Equity Distribution Agreement.
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: of July 31, 2020, the Company was in violation of a financial covenant under the SVB Loan Agreement.
−Removed: Additionally, due to the
−Removed: untimely filing of our second quarter Form 10-Q with the SEC, the Company was in default under the SVB Loan Agreement.
−Removed: September 2020, the Company paid down the outstanding Revolver balance of $3.4 million in full and transferred $0.35 million into
−Removed: a restricted cash money market account with SVB to serve as collateral for the Company’s letters of credit supporting its
−Removed: Prior to September 2020, the collateral for the letters of credit was accounted for as a reduction in the availability
−Removed: under the Revolver.
−Removed: As of September 30, 2020, and through the date of termination of the SVB Loan Agreement, there was no balance
−Removed: outstanding on the Revolver.
−Removed: On October 19, 2020 SVB agreed to forebear from exercising its rights and remedies with respect
−Removed: to the defaults and the Company as a result was in compliance with the terms of the SVB Loan Agreement through the
−Removed: date of its termination in January 2021.
−Removed: January 2020, we sold 20,000 preferred shares to investors, led by 1315 Capital, for net proceeds of approximately $19.5 million;
−Removed: see Note 13, Equity of the footnotes to the financial statements for more detail.
−Removed: April 2020, the Company applied for various federal stimulus grants and advances made available under Title 1 of the CARES Act.
−Removed: As of September 30, 2020, we received $2.1 million in advances under the CMS accelerated and advance payment program, as well
−Removed: as a $0.65 million grant from HHS.
−Removed: The CMS advance will be offset against future Medicare billings of the Company, and we applied
−Removed: the HHS grant in its entirety towards qualified second quarter expenses.
−Removed: These expenses related to lab equipment and supplies
−Removed: purchased to prevent, prepare for, and respond to coronavirus, including development of coronavirus and serology tests, as well
−Removed: as expenses that would have been covered by revenue lost to coronavirus during the second quarter.
−Removed: April and early May 2020, the Company made payments totaling $888,000 to CGI for funds withheld from the Excess Consideration
−Removed: Note to satisfy certain adjustments and indemnification obligations under the Asset Purchase Agreement dated July 15, 2019.
−Removed: January 7, 2021, the Company entered into promissory notes with Ampersand, in the amount of $3 million, and 1315 Capital, in the
−Removed: amount of $2 million, respectively (together, the “Notes”) and a related security agreement (the “Security Agreement”).
−Removed: rate of interest on the Notes is equal to eight percent (8.0%) per annum and their maturity date is the earlier of (a) June 30,
−Removed: 2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Notes.
−Removed: interest payments are due on the Notes until their maturity date.
−Removed: All payments on the Notes are pari passu.
−Removed: connection with the Security Agreement, the Notes are secured by a first priority lien and security interest on substantially
−Removed: all of the assets of the Company.
−Removed: Additionally, if a change of control of the Company occurs (as defined in the Notes) the Company
−Removed: is required to make a prepayment of the Notes in an amount equal to the unpaid principal amount, all accrued and unpaid interest,
−Removed: and all other amounts payable under the Notes out of the net cash proceeds received by the Company from the consummation of the
−Removed: transactions related to such change of control.
−Removed: The Company may prepay the Notes in whole or in part at any time or from time
−Removed: to time without penalty or premium by paying the principal amount to be prepaid together with accrued interest thereon to the
−Removed: date of prepayment.
−Removed: No prepaid amount may be re-borrowed.
−Removed: of December 31, 2020, contractual obligations with terms exceeding one year and estimated minimum future rental payments required
−Removed: by non-cancelable operating leases with initial or remaining lease terms exceeding one year are as follows:
−Removed: lease obligations
−Removed: Biosciences, Inc.
−Removed: Report on Form 10-K
−Removed: Company has and may continue to delay, scale-back, or eliminate certain of its activities and other aspects of its operations
−Removed: until such time as the Company is successful in securing additional funding.
−Removed: The Company is exploring various dilutive and non-dilutive
−Removed: sources of funding, including equity and debt financings, strategic alliances, business development and other sources.
−Removed: success of the Company is dependent upon its ability to obtain additional funding.
−Removed: There can be no assurance, however, that the
−Removed: Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all.
−Removed: factors raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: Company’s cash and cash equivalents balance is decreasing and we will not generate positive cash flows from operations for
−Removed: the year ending December 31, 2021.
−Removed: We intend to meet our ongoing capital needs by using our available cash, including the Ampersand
−Removed: and 1315 Capital loans, as well as revenue growth and margin improvement;
−Removed: collection of accounts receivable;
−Removed: containment of costs;
−Removed: and the potential use of other financing options.
−Removed: the Company’s delisting from Nasdaq in February 2021, its ability to raise additional capital may be materially adversely
−Removed: In addition, the Company’s inability to use Form S-3 after it files this Report may have an adverse impact on
−Removed: our ability to raise additional capital.
−Removed: There is no assurance we will be successful in meeting our capital requirements prior
−Removed: to becoming cash flow positive.
−Removed: AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
−Removed: are a “smaller reporting company”
−Removed: for purposes of the disclosure requirements of Item 305 of Regulation S-K and, therefore,
−Removed: we are not required to provide this information.
−Removed: STATEMENTS AND SUPPLEMENTARY DATA
−Removed: statements and the financial statement schedule specified by this Item 8, together with the report thereon of BDO USA, LLP, are
−Removed: presented following Item 15 of this Annual Report on Form 10-K.
−Removed: IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES
+Added: Future earnings,
+Added: if any, will be used to finance the future operation and growth of our businesses.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.