FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q (Form 10-Q) contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Exchange Act. Statements that are not historical facts, including statements about our plans, objectives, beliefs and expectations, are forward-looking statements. Forward-looking statements include statements preceded by, followed by or that include the words "believes," "expects," "anticipates," "plans," "estimates," "intends," "projects," "should," "could," "may," "will" or similar words and expressions. These forward-looking statements are contained throughout this Form 10-Q.
Forward-looking statements are only predictions and are not guarantees of future performance. These statements are based on current expectations and assumptions involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. These predictions are also affected by known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from those expressed or implied by any forward-looking statement. Many of these factors are beyond our ability to control or predict. Our actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors. Such factors include, but are not limited to, the following:
? adverse impact of Coronavirus (COVID-19) pandemic due to the slowdown in demand for our clinical services and pharma services, a reduction in samples received and testing volume and delayed third party collections and other factors; ? we have a history of operating losses, and our clinical services and pharma services have generated limited revenue; ? we expect to incur net losses for the foreseeable future and may never achieve or sustain profitability; ? our limited operating history and the limited revenue generated from our business thus far and fluctuating quarterly and annual revenue and operating results, including as a result of how we recognize revenue; ? we depend on sales and reimbursements from our clinical services for more than 50% of our revenue, and we will need to generate sufficient revenue from these and other products and/or solutions that we develop or require to grow our business; ? we rely on third parties to process and transmit claims to payers for our clinical services, and any delay, data loss, or other disruption in processing or transmitting could have an adverse effect on our revenue and financial condition; ? our ability to utilize our commercial and operating experience to sell our clinical and pharma services; ? our ability to compete successfully in the markets our clinical services and pharma services operate in; ? our ability to obtain, retain and increase sufficient levels of third party reimbursement for our molecular diagnostic tests in a changing and challenging reimbursement environment, including our current dependence on a concentrated number of third-party payers and the lack of timeliness of their payments, and the potential failure of such payments to ever occur; ? our billing practices and those of our third-party billing providers to effectively bill and collect on claims for the sale of our tests; ? our revenue recognition is based in part on our estimates for future collections and such estimates may prove to be incorrect; 33 ? a deterioration in the collectability of our accounts receivable could have a material adverse effect on our business, financial condition and results of operations; ? our inability to finance our business on acceptable terms in the future may limit our ability to grow our business, develop and commercialize products and services, develop and commercialize new molecular diagnostic solutions and technologies and expand our pharma services; ? our ability to comply with financial covenants under our current line of credit facility and comply with our debt obligations and our ability to expand our working capital borrowing base to provide sufficient working capital financing during growth periods; ? we have issued convertible preferred stock and may issue additional convertible preferred stock in the future, and the terms of our preferred stock may dilute our common stock; ? two private equity firms and their affiliates control, on an as-converted basis, 66% of our fully diluted outstanding shares of common stock through their holdings of Series B Convertible Preferred Stock, par value$0.01 per share ("Series B Preferred Stock"), and this concentration of ownership along with having authority for designation rights for a majority of our directors will have a substantial influence on our decisions; ? billing for our clinical services tests is complex, and we must dedicate substantial time and resources to the billing process to be paid for our clinical services; ? we depend on a few payers for a significant portion of our revenue for our clinical services, and if one or more significant payers stops providing reimbursement or decreases the amount of reimbursement for our tests, our revenue could decline; ? if payers do not provide reimbursement, rescind or modify their reimbursement policies or delay payments for clinical services, our commercial success could be compromised; ? developing new tests and related services and solutions includes a lengthy and complex process with uncertain results; ? the effect of potential adverse findings resulting from regulatory audits of our billing and payment practices and the impact such results could have on our clinical services; ? the demand for our molecular diagnostic tests from physicians and patients; ? our products and services continuing to perform as expected; ? claims against us for inaccurate results from our molecular diagnostic tests; ? our obligations to make royalty and milestone payments to our licensors; ? our ability to obtain data and samples to perform sufficient clinical studies to successfully publish data demonstrating the clinical relevance and value of our molecular diagnostic tests, including to support sufficient levels of third party reimbursement; ? our dependence on third parties for the supply of some of the materials used in our molecular diagnostic tests and pharma services; ? our ability to scale our operations or delays or reagent and supply shortages for our tests and services; ? our ability to develop or acquire tests, services or solutions; 34 ? the ability of our clinical services to enter into additional clinical study collaborations with highly regarded institutions; ? the effect current and future laws, licensing requirements and regulation have on our business including the changingU.S. Food and Drug Administration environment as it relates to molecular diagnostics and pharma services and laboratory developed tests (LDT's); ? changes in governmental regulations mandating price controls and limitations on patient access to our products and services; ? if we fail to comply with Federal, State and foreign laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business; ? legislation reforming theU.S. healthcare system; ? a failure to comply with Federal and State laws and regulations pertaining to our payment practices; ? our ability to comply with fraud and abuse laws or payer regulations could result in our being excluded from participation in Medicare, Medicaid or other governmental payer programs; ? compliance with numerous statutes and regulations pertaining to our business; ? the effect of The Eliminating Kickbacks in Recovery Act of 2018 as it potentially impacts our ability to incentivize our sales personnel appropriately; ? our ability to realize all of the anticipated benefits of the acquisition of our pharma services or those benefits, if any, taking longer to realize than expected; ? if pharmaceutical and biotech companies, universities and contract research organizations performing clinical trials decide not to use our tests and services, we may be unable to generate sufficient revenue to sustain our pharma services; ? if we fail to perform our pharma services in accordance with contractual and regulatory requirements, and ethical considerations, we could be subject to significant costs or liability; ? our ability to compete in the markets our clinical services operate in; ? our ability to attract and retain key employees and management personnel; ? our reliance on our sales and marketing forces for future business growth and our ability to continue to expand our sales and marketing forces; ? our limited experience in marketing and selling our products; ? the ability of our molecular diagnostic tests to compete successfully with physicians and members of the medical community who use traditional methods to diagnose gastrointestinal and endocrine cancers, competitors offering broader product lines outside of the molecular diagnostic testing market and having greater brand recognition than we do, and companies with greater financial resources; ? our ability to license rights to use technologies in order to commercialize new products and services; ? our involvement in future litigation against us or our ability to collect on judgements found in our favor; ? the effect of acts of nature, seasonal results and adverse weather conditions, hurricanes and floods, on our business and our suppliers; 35 ? our use of hazardous materials; ? the susceptibility of our information systems to security breaches, loss of data and other disruptions; ? catastrophic loss of our laboratories; ? our ability to obtain and maintain sufficient qualified laboratory space to meet our processing needs for all of our business as well as our ability to pass regulatory inspections and continue to be Clinical Laboratory Improvement Amendments ("CLIA") and theCollege of American Pathologists ("CAP") certified or accredited; ? compliance with theU.S. Foreign Corrupt Practices Act and anti-bribery laws; ? our ability to respond to rapid scientific changes in the areas in which we operate; ? our compliance with our license agreements and our ability to protect and defend our intellectual property rights; ? patent infringement claims against us; ? changes inU.S. and global patent law; ? tax reform legislation; ? stock dilution; ? changes in financial accounting standards or practices; ? exposure to international law, regulations and risk as a result of international expansion; ? we may acquire businesses or assets or make investments in other companies or testing, service or solution technologies that could harm our operating results, dilute our stockholders' ownership, increase our debts or cause us to incur significant expense; ? the impact of contingent liabilities on our financial condition; ? the results of any future impairment testing for intangible assets as required underU.S. generally accepted accounting principles ("GAAP"); ? our ability to maintain and implement effective internal controls over financial reporting especially as we are consolidating operations; ? if our information technology or communications systems fail or we experience a significant interruption in their operation, our reputation, business and results of operations could be materially and adversely affected; ? the impact of future issuances of debt, common and preferred shares on stockholders' interest and stock price; ? our ability to report financial results on a timely and accurate basis; ? our ability to manage our growth or unexpected declines; ? the potential that the temporary equity classification of our preferred stock and the amortization and impairment of certain intangible assets set forth herein may trigger a Nasdaq compliance default for failure to meet minimum stockholder equity requirements which could result in a delisting of our common stock from Nasdaq leading to a possible reduced stock price; potential difficulty in raising additional capital or debt as well as loss of exemptions from various state securities laws which could hamper action plans to remediate such a Nasdaq compliance default; ? uncertainty regarding the regulatory obligations related to our receipt of$650,000 funding for COVID testing; ? our ability to rebuild our cost structure in anticipation of volume growth that does not happen as planned; ? the potential impact on customers currently in clinical trials in ourRutherford, NJ lab that we are now relocating toNorth Carolina which may require revalidation in the new site; ? the impact of increased costs building expanded laboratory capabilities inNorth Carolina in anticipation of the move fromRutherford, NJ and the potential loss of customers related to the move; ? our ability to efficiently execute and complete the planned laboratory move fromRutherford, NJ toNorth Carolina on a timely basis within our forecasted costs; ? the risk of loss of personnel that are uniquely qualified to perform the breadth of specialty testing and lab applications necessary for developing customized assays in our pharma solutions business; and ? the risk related to our sales reps fully reengaging with customers after reducing physical visits by our commercial team during the pandemic. 36
Please see Part I - Item 1A - "Risk Factors" in our Form 10-K for the fiscal
year ended
OVERVIEW
We are an emerging leader in enabling precision medicine principally in oncology by offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications through our clinical services and pharma services. Through our clinical services, we enable physicians to personalize the clinical management of each individual patient by providing genomic information to better diagnose, monitor and inform cancer treatment. Our clinical services provide clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Through our pharma services, we develop, commercialize and provide molecular- and biomarker-based tests and services and provide companies with customized solutions for patient stratification and treatment selection through an extensive suite of molecular and biomarker-based testing services, DNA- and RNA- extraction and customized assay development and trial design consultation. Our pharma services provide pharmacogenomics testing, genotyping, biorepository and other specialized services to the pharmaceutical and biotech industries and advances personalized medicine by partnering with pharmaceutical, academic and technology leaders to effectively integrate pharmacogenomics into drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.
During fiscal 2019, in connection with the acquisition of our pharma services,
we raised
Impact of COVID-19 pandemic
We have taken what we believe are all necessary precautions to safeguard our
employees from the Coronavirus (COVID-19) pandemic. We are following
The extent to which the COVID-19 pandemic impacts our operations continues to depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak. In particular, the continued spread of the coronavirus globally has adversely affecting global economies and financial markets resulting in an economic downturn which could materially and adversely impact our operations including, without limitation, the functioning of our laboratories, the availability of supplies including reagents, the progress and data collection of our pharma services, customer demand and travel and employee health and availability.
37
We believe that the COVID-19 pandemic will also adversely impact our results of
operations, cash flows and financial condition for the second quarter of fiscal
2020 and possibly beyond. Our fiscal 2020 first quarter revenue was impacted by
lower than expected clinical service volume throughout
However, as of the date of this Report, our overall business is still down approximately 30% from our run rate before the pandemic. We have continued to add resources to support the increased volume consistent with the changing environment. However, as we rebuild our cost structure to support the improved volume, there is risk that the anticipated volume growth will not materialize as planned and we will be required to adjust accordingly.
To optimize the pharma services lab operations we are transitioning lab work
from
All of our labs are currently operating and we believe we are appropriately staffed for the volume of work. At this time, we do not anticipate any lab closures beyond temporary work stoppages from time to time to clean and disinfect the labs. Lab supplies including reagents have been secured to mitigate any potential supply chain issues for the foreseeable future and we are not observing any shortages due to supply chain issues. Our third party clinical services billing and collections company has taken steps to continue operations remotely. There have been indications that payer processing may slow down but so far there has been little or no material impact to our collections.
As of
Additional Reimbursement Coverage During 2020
Reimbursement progress is key for any molecular diagnostic company. We have been successful to date in expanding the reimbursement of our products in 2020. Specifically, the most significant progress we have made regarding payers to date in 2020 is as follows:
? InFebruary 2020 , we announced an increase in Medicare reimbursement for our ThyraMIR® test from$1,800 to$3,000 , retroactive toJanuary 1, 2020 , reflecting a re-evaluation of the technical and clinical performance of the test relative to other molecular tests in the market and their respective prices. ? InMarch 2020 , we announced we had entered into a contract withBlue Cross Blue Shield of Massachusetts making ThyGeNEXT® and ThyraMIR® tests covered in-network services for their more than 3 million members inMassachusetts and acrossNew England . 38 ? InMarch 2020 , we announced we had entered into a contract with CareFirstBlue Cross Blue Shield , making ThyGeNEXT® and ThyraMIR® tests covered in-network services for their more than 3.3 million members inMaryland ,Washington, D.C. , andNorthern Virginia . ? InMarch 2020 , we announced we had entered into a contract withPremera Blue Cross , making ThyGeNEXT® and ThyraMIR® tests covered in-network services for their more than 2 million members inWashington State andAlaska . ? InApril 2020 , we executed an agreement with Avalon Healthcare Solutions (Avalon), a laboratory benefit manager representing numerous health plans. Our agreement with Avalon offers us in-network status to approximately 5.8 million lives covered by the following health plans:Blue Cross Blue Shield North Carolina ,South Carolina ,Kansas City andVermont , andCapital Blue Cross of Central Pennsylvania . ? InApril 2020 , we executed a contract withBlue Cross of Idaho making ThyGeNEXT® and ThyraMIR® tests covered in-network services for their more than 576 thousand members. ? InMay 2020 , we executed a contract withBlue Cross Blue Shield of Wyoming . Revenue Recognition
Clinical services derive its revenues from the performance of its proprietary assays or tests. The Company's performance obligation is fulfilled upon completion, review and release of test results to the customer. The Company subsequently bills third-party payers or direct-bill payers for the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction price or net realizable value ("NRV"), which is determined based on historical collection rates by each payer category for each proprietary test offered by the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary tests, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience.
For our clinical services, we regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates and adjust the NRV's and related contractual allowances accordingly. If actual collections and related NRV's vary significantly from our estimates, we adjust the estimates of contractual allowances, which would affect net revenue in the period such variances become known.
For our pharma services customers, performance obligations are satisfied at a point in time as the Company processes samples delivered by the customer. Project level activities, including study setup and project management, are satisfied over the life of the contract. Revenues are recognized at a point in time when the test results or other deliverables are reported to the customer.
Deferred Revenue
For our pharma services, project level fee revenue is recognized as deferred revenue and recorded at fair value. It represents payments received in advance of services rendered and is recognized ratably over the life of the contract.
Cost of Revenue
Cost of revenue consists primarily of the costs associated with operating our laboratories and other costs directly related to our tests. Personnel costs, which constitute the largest portion of cost of services, include all labor related costs, such as salaries, bonuses, fringe benefits and payroll taxes for laboratory personnel. Other direct costs include, but are not limited to, laboratory supplies, certain consulting expenses, royalty expenses, and facility expenses.
39
CONDENSED CONSOLIDATED RESULTS OF OPERATIONS
The following table sets forth, for the periods indicated, certain statements of operations data and have been restated to reflect the additional amortization expense and certain other adjustments. The trends illustrated in this table may not be indicative of future results.
Condensed Consolidated Results of Continuing Operations for the Quarter EndedMarch 31, 2020 Compared to the Quarter EndedMarch 31, 2019 (unaudited, in thousands) As Restated Three Months Ended March 31, 2020 2020 2019 2019 Revenue, net$ 9,059 100.0 %$ 6,010 100.0 % Cost of revenue 6,113 67.5 % 2,622 43.6 % Gross profit 2,946 32.5 % 3,388 56.4 % Operating expenses: Sales and marketing 2,481 27.4 % 2,411 40.1 % Research and development 809 8.9 % 528 8.8 % General and administrative 4,893 54.0 % 2,735 45.5 % Acquisition related amortization expense 1,115 12.3 % 897 14.9 % Total operating expenses 9,298 102.6 % 6,571 109.3 % Operating loss (6,352 ) -70.1 % (3,183 ) -53.0 % Interest accretion (109 ) -1.2 % (129 ) -2.1 % Other income (expense), net 47 0.5 % 48 0.8 %
Loss from continuing operations before tax (6,414 ) -70.8 % (3,264 ) -54.3 % Provision for income taxes
15 0.2 % 5 0.1 % Loss from continuing operations (6,429 ) -71.0 % (3,269 ) -54.4 %
Loss from discontinued operations, net of tax (65 ) -0.7 % (57 ) -0.9 %
Net loss$ (6,494 ) -71.7 %$ (3,326 ) -55.3 % Revenue, net
Consolidated revenue, net for the three months ended
Cost of revenue
Consolidated cost of revenue for the three months ended
Gross profit
Consolidated gross profit was approximately
40 Sales and marketing expense
Sales and marketing expense was
Research and development
Research and development expense was
General and administrative
General and administrative expense for the three months ended
Acquisition related amortization expense
During the three months ended
Operating loss
Operating loss from continuing operations was
Provision for income taxes
Income tax expense was approximately
Loss from discontinued operations, net of tax
We had a loss from discontinued operations of approximately
41
LIQUIDITY AND CAPITAL RESOURCES
For the three months ended
During the three months ended
For the three months ended
In
As of
In
As of
During April and early
We do not expect to generate positive cash flows from operations for the year
ending
42 Inflation
We do not believe that inflation had a significant impact on our results of operations for the periods presented. On an ongoing basis, we attempt to minimize any effects of inflation on our operating results by controlling operating costs and whenever possible, seeking to insure that billing rates reflect increases in costs due to inflation.
Off-Balance Sheet Arrangements
None.
© Edgar Online, source