Oncocyte(US:OCX)2022-03-11 22:17Part I. Financial Information Item 1. Business Oncocyte is a molecular diagnostics company commercializing proprietary cancer tests through strategic acquisitions - Oncocyte is a molecular diagnostics company focused on developing and commercializing proprietary LDTs for unmet medical needs across the cancer care continuum, initially focusing on lung cancer18 - Strategic acquisitions transformed Oncocyte: Razor Genomics (DetermaRx in 2019), Insight Genetics (DetermaIO in 2020), and Chronix Biomedical (DetermaCNI, TheraSure Transplant Monitor in 2021)19202122 - DetermaRx is the first and only test to predict early-stage lung cancer recurrence and chemotherapy response, commercialized and reimbursed by Medicare2034 - DetermaIO is a gene expression assay designed to identify patients most likely to respond to immune checkpoint inhibition (ICI), showing 41% higher response (PFS) compared to standard of care biomarker (PD-L1) in clinical studies2144 - DetermaCNI is a patented, blood-only test for treatment response monitoring, detecting changes in circulating tumor DNA (ctDNA) levels without requiring an upfront tissue sample22 - The company's business strategy aims to be a 'one-stop lab' for solid tumor treatment decisions, offering proprietary and traditional biomarker testing from a single patient sample3031 DetermaRx Market Opportunity (U.S.) | Metric | Value | | :----- | :---- | | Annual U.S. Patients | ~40,000 | | Market Opportunity | ~$126 million | | Reimbursement Basis | CMS approved in 2021 | DetermaIO Market Opportunity (U.S.) | Metric | Value | | :----- | :---- | | Annual U.S. Patients Eligible for ICI | >750,000 | | Potential TAM (Clinical Use) | ~$3 billion | | Pharma Services Market Opportunity | ~$1 billion | - DetermaIO measures the expression level of twenty-seven selected genes using a proprietary algorithm to classify patients as likely responders or non-responders to immune therapy, integrating signals from the immune inflammatory infiltrates and wound response4648 - The company's commercialization efforts for DetermaRx involved a focused sales team, early adopter sites, and virtual education programs, reaching over 5,000 healthcare professionals by the end of 202159 - DetermaRx has been ordered at over 183 hospitals and by 213 physicians in the U.S. since its broad commercial launch in March 202060 - An exclusive sublicense agreement with Burning Rock Biotech Limited grants rights to DetermaRx in the PRC Territory, with Oncocyte receiving $3 million of initial milestone payments as of December 31, 202161 - Medicare reimbursement approval is critical for cancer diagnostics, with Noridian Healthcare Solutions, LLC (MAC for California) delivering a final coverage and pricing decision for DetermaRx in August 2020, covering ~70% of eligible patients6364 - The company faces high competition in the molecular diagnostics industry, with many competitors having substantially more resources and experience; DetermaRx has no direct market competitor for its specific indication, while DetermaIO and DetermaCNI compete with existing and developing biomarkers/tests74757677 - Oncocyte relies on patents and trade secrets, holding exclusive rights to patents for DetermaRx (expiring 2032-2033) and intellectual property from Insight and Chronix (expiring 2031-2034)8586878889 - The company's LDTs (DetermaRx, DetermaIO) are regulated under CLIA and applicable state laws; the FDA has historically exercised enforcement restraint over most LDTs but has indicated intentions to increase regulation, with potential legislative changes (VALID Act, VITAL Act) creating uncertainty103105107108109112114 - Oncocyte operates CLIA-certified laboratories in Irvine, California (principal executive and administrative offices, primary clinical lab), Nashville, Tennessee (Immune Diagnostic Center of Excellence), and Göttingen, Germany (Blood Based Monitoring Center of Excellence)5883 Item 1A. Risk Factors The company faces significant risks in acquisition obligations, operating losses, commercialization, and regulations - The company may incur significant cash payment and common stock issuance obligations from the Razor, Insight, and Chronix acquisitions, including up to $6.0 million for Insight milestones and up to $14 million for Chronix milestones, plus earnout considerations167171172 Operating Losses and Accumulated Deficit | Metric | 2021 (Millions) | 2020 (Millions) | | :----- | :-------------- | :-------------- | | Net Loss | $64.1 | $29.9 | | Accumulated Deficit (as of Dec 31, 2021) | $187.8 | N/A | - Future profitability is uncertain, and the company will likely need to issue additional equity or debt to fund operations until revenues are sufficient176177 - Commercialization of diagnostic tests is subject to risks such as physician reluctance, competition from existing and new diagnostic tests, and limited capital, marketing, sales, and regulatory compliance resources182183 - Technology transfer challenges and expenses may arise when adding new tests or expanding into new geographical areas/instrument platforms185 - Reliance on a limited number of manufacturers for molecular diagnostic testing equipment and reagents poses a supply chain risk191 - The company's financial success depends on its ability to obtain commercially valuable patent claims, protect intellectual property rights, and operate without infringing on others' rights, facing challenges from patent law changes and potential litigation250251252254257259264 - The ongoing COVID-19 pandemic has negatively impacted and continues to affect operations, revenue generation, clinical trial activities (delays in site initiations, patient enrollment), and access to capital, creating significant volatility and uncertainty269271272273274275277278279 - The commercial success of diagnostic tests is highly dependent on the availability and sufficiency of third-party payer coverage and reimbursement, which may be limited or unavailable, and subject to changes in healthcare laws and policies (e.g., PAMA)234235237238242 - The company is subject to extensive federal and state laws governing clinical laboratories (CLIA), FDA regulation of LDTs, data privacy (HIPAA, state laws like CCPA/CPRA, GDPR), physician referral prohibitions (Stark Law), fraud and abuse laws (Anti-Kickback Statute, False Claims Act, EKRA), and corporate practice of medicine, with non-compliance carrying significant penalties103105112113114115118119120122131132133134135136137138139140141143144145146147148149150243244245246 - Risks related to common stock include high price volatility, the company's policy of not paying dividends, potential dilution from future equity issuances, and the possibility of its former parent company (Lineage Cell Therapeutics, Inc) selling its shares282286288290291292 Item 1B. Unresolved Staff Comments The company reports no unresolved comments from regulatory staff - Not applicable293 Item 2. Properties The company leases its principal offices and laboratories in California, Tennessee, and Brisbane - Principal executive and administrative offices and primary CLIA-certified laboratory are in Irvine, California (lease expires September 2027)294 - Operates a CLIA-certified laboratory in Nashville, Tennessee (lease expires April 2024)295 - Subleases laboratory space in Brisbane, California (sublease expires March 2023)295 Item 3. Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not presently involved in any material litigation or proceedings296 Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - Not applicable297 Part II. Other Information Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities The company's common stock trades on NASDAQ, it does not pay dividends, and has active equity compensation plans - Common stock began trading on the NASDAQ Global Market under the symbol 'OCX' on March 8, 2021299 - The company has not declared or paid any cash dividends on its common stock and anticipates using future earnings to finance business growth286300 - As of March 3, 2022, there were approximately 318 holders of record of the company's common stock301 Equity Compensation Plan Summary (as of Dec 31, 2021) | Metric | Value (in thousands) | | :------------------------------------------------ | :------------------- | | Shares to be Issued upon Exercise of Outstanding Options, Warrants and Rights | 11,602 | | Weighted Average Exercise Price of Outstanding Options, Warrants and Rights | $3.63 | | Number of Shares Remaining Available for Future Issuance | 9,006 | Item 6. Selected Financial Data This item is reserved and contains no selected financial data - This item is reserved and contains no selected financial data305 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Revenues grew significantly but were outpaced by rising operating expenses, leading to a larger net loss - Oncocyte is a molecular diagnostics company focused on developing and commercializing proprietary LDTs for cancer, with DetermaRx commercialized and DetermaIO, DetermaTx, and DetermaCNI in the development pipeline307308309 - The company has incurred operating losses and negative cash flows since inception, with an accumulated deficit of $187.8 million as of December 31, 2021373 - The COVID-19 pandemic has significantly impacted operations, revenue generation, and financing activities, causing uncertainties in forecasting demand for diagnostic testing and Pharma Services, and delays in clinical trials345346347348 Revenues (in thousands) | Category | 2021 | 2020 | $ Change | % Change | | :--------- | :--- | :--- | :------- | :------- | | Total Revenues | $7,727 | $1,216 | $6,511 | 535% | Revenue Breakdown by Class (Percentage of Consolidated Revenues) | Class | 2021 | 2020 | | :------------ | :--- | :--- | | DetermaRx | 32% | 45% | | Pharma Services | 19% | 55% | | Licensing | 49% | - | Key Operating Expenses (in thousands) | Expense Category | 2021 | 2020 | $ Change | % Change | | :--------------- | :--- | :--- | :------- | :------- | | Cost of revenues | $7,539 | $1,855 | $5,684 | 306% | | Research and development | $13,631 | $9,800 | $3,831 | 39% | | Sales and marketing | $11,167 | $6,494 | $4,673 | 72% | | General and administrative | $22,336 | $16,788 | $5,548 | 33% | | Change in fair value of contingent consideration | $27,266 | $(4,010) | $31,276 | -780% | | Loss from operations | $(74,212) | $(29,711) | $(44,501) | 150% | | Net Loss | $(64,097) | $(29,932) | $(34,165) | 114% | - The significant increase in 'Change in fair value of contingent consideration' to a $27.3 million unrealized loss in 2021 (from a $4.0 million gain in 2020) was primarily due to revised estimates on the timing of possible future payouts related to Insight and Chronix acquisitions366 - An income tax benefit of $9.3 million in 2021 (vs $1.3 million in 2020) resulted from a partial release of the valuation allowance due to deferred tax liabilities generated by acquired intangible assets from Chronix and Razor acquisitions369370 Cash and Marketable Securities (as of Dec 31, 2021) | Asset Category | Amount (Millions) | | :------------- | :---------------- | | Cash and cash equivalents | $35.6 | | Marketable equity securities | $0.9 | - The company believes current cash and marketable securities are sufficient for operations for at least 12 months but will need additional financing to cover increasing operating expenses for development and commercialization311374381 - Net cash used in operating activities was $35.9 million in 2021, up from $26.0 million in 2020, reflecting increased operating expenses383 - Net cash provided by financing activities was $78.4 million in 2021, primarily from common stock sales (including ATM offerings) and warrant/stock option exercises386 - The company's $1.14 million PPP loan was forgiven in May 2021, recognized as a gain on extinguishment of debt376 Item 7A. Quantitative and Qualitative Disclosures about Market Risk The company is exempt from market risk disclosure requirements as a smaller reporting company - As a smaller reporting company, Oncocyte is not required to provide quantitative and qualitative disclosures about market risk388 Item 8. Financial Statements and Supplementary Data This section presents audited consolidated financial statements, notes, and highlights critical audit matters - The independent registered public accounting firm (Withum Smith+Brown, PC) issued an unqualified opinion on the consolidated financial statements for the year ended December 31, 2021394 - Critical audit matters for 2021 included the accounting for the Chronix BioMedical, Inc acquisition, specifically the fair value determination of identified intangible assets ($46.8 million IPR&D) and the valuation of contingent consideration liabilities ($7.1 million for DetermaIO and $69.6 million for TheraSure tests)400401406 Consolidated Balance Sheet Highlights (in thousands) | Metric | Dec 31, 2021 | Dec 31, 2020 | | :------------------------------------------ | :----------- | :----------- | | Total Assets | $159,563 | $55,419 | | Total Liabilities | $94,346 | $21,936 | | Total Shareholders' Equity | $65,217 | $33,483 | Consolidated Statements of Operations Highlights (in thousands) | Metric | 2021 | 2020 | | :------------------------------------------ | :--- | :--- | | Net revenue | $7,727 | $1,216 | | Gross profit (loss) | $188 | $(639) | | Loss from operations | $(74,212) | $(29,711) | | Net Loss | $(64,097) | $(29,932) | | Net loss per share: basic and diluted | $(0.72) | $(0.46) | Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 2021 | 2020 | | :------------------------------------------ | :--- | :--- | | Net cash used in operating activities | $(35,941) | $(25,980) | | Net cash used in investing activities | $(13,961) | $(11,748) | | Net cash provided by financing activities | $78,364 | $22,799 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $28,462 | $(14,929) | - Oncocyte completed the acquisition of Insight Genetics on January 31, 2020, for $7 million cash and $5 million in common stock, plus contingent consideration of up to $6.0 million for milestones and tiered revenue share payments; the acquisition resulted in $9.187 million in goodwill and $14.65 million in IPR&D for DetermaIO432539540542544547552554 - On February 24, 2021, Oncocyte acquired the remaining 75% ownership of Razor Genomics for $10 million cash and $5.7 million in common stock, consolidating Razor's results; the Razor intangible asset was recorded at $32.797 million431577592 - On April 15, 2021, Oncocyte acquired Chronix Biomedical for $4.0 million cash and $3.298 million in common stock, plus contingent consideration (milestone payments up to $14 million, royalty payments up to 15% of net collections, and transplant sale payments up to 75% of net collections); the acquisition resulted in $9.490 million in goodwill and $46.8 million in IPR&D for TheraSure™-CNI Monitor and TheraSure™ Transplant Monitor433596597598607610611623 Goodwill and Intangible Assets, Net (in thousands) | Asset Category | Dec 31, 2021 | Dec 31, 2020 | | :------------------------------------------ | :----------- | :----------- | | Total Goodwill | $18,684 | $9,187 | | Acquired IPR&D - DetermaIO | $14,650 | $14,650 | | Acquired IPR&D - TheraSure™ | $46,800 | - | | Acquired intangible assets - customer relationship – Insight | $440 | $440 | | Acquired intangible assets - Razor | $32,797 | - | | Accumulated amortization | $(3,442) | $(81) | | Intangible assets, net | $91,245 | $15,009 | Contingent Consideration Liabilities (in thousands) | Acquisition | Fair Value (Dec 31, 2021) | | :---------- | :------------------------ | | Insight Merger | $7,060 | | Chronix Merger | $69,621 | - As of December 31, 2021, Oncocyte had 92,231,917 shares of common stock outstanding and 2,251,576 common stock purchase warrants outstanding with exercise prices ranging from $1.69 to $5.50634635 Stock-Based Compensation Expense (in thousands) | Category | 2021 | 2020 | | :-------------------------- | :--- | :--- | | Cost of revenues | $255 | $93 | | Research and development | $1,517 | $1,245 | | Sales and marketing | $1,296 | $541 | | General and administrative | $3,773 | $3,187 | | Total stock-based compensation expense | $6,841 | $5,066 | Revenue Disaggregation by Geographical Location | Location | 2021 | 2020 | | :-------------------------------- | :--- | :--- | | United States | 45% | 61% | | Outside of the United States – Pharma Services | 6% | 39% | | Outside of the United States – Licensing | 49% | - | - As of December 31, 2021, Oncocyte had federal NOL carryforwards of $204.8 million and state NOLs of $95.5 million, with a full valuation allowance established due to uncertainty of realizing future tax benefits, except for a partial release related to acquired intangible assets670672 - On January 13, 2022, Oncocyte entered into a Collaboration Agreement with Life Technologies Corporation (LTC) to co-develop and commercialize LTC's Oncomine Comprehensive Assay Plus (OCA Plus) and Oncocyte's DetermaIO assay as IVD assays on LTC's Genexus system725727 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure There have been no changes in or disagreements with accountants - Not applicable737 Item 9A. Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective - Management determined that disclosure controls and procedures were effective as of December 31, 2021738 - No changes in internal control over financial reporting occurred during Q4 2021 that materially affected, or are reasonably likely to materially affect, internal control over financial reporting739 - Management assessed the effectiveness of internal control over financial reporting as of December 31, 2021, based on the COSO 2013 framework, and concluded it was effective742 Item 9B. Other Information There is no other information to report under this item - None743 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections This item is not applicable to the company's operations - Not applicable744 Part III. Item 10. Directors, Executive Officers, and Corporate Governance Director and officer information is incorporated by reference from the company's Proxy Statement - Information is incorporated by reference from the 2022 Annual Meeting of Shareholders Proxy Statement746 - The company has a written Code of Business Conduct and Ethics applicable to all officers, employees, and directors, promoting ethical conduct, accurate disclosure, and compliance with regulations747 Item 11. Executive Compensation Executive compensation details are incorporated by reference from the company's Proxy Statement - Information is incorporated by reference from the 2022 Annual Meeting of Shareholders Proxy Statement749 Item 12. Security Ownership of Certain Beneficial Owners and Management, and Related Stockholder Matters Security ownership information is incorporated by reference from the company's Proxy Statement - Information is incorporated by reference from the 2022 Annual Meeting of Shareholders Proxy Statement750 Item 13. Certain Relationships and Related Transactions, and Director Independence Information on related transactions is incorporated by reference from the company's Proxy Statement - Information is incorporated by reference from the 2022 Annual Meeting of Shareholders Proxy Statement751 Item 14. Principal Accounting Fees and Services Details on accounting fees are incorporated by reference from the company's Proxy Statement - Information is incorporated by reference from the 2022 Annual Meeting of Shareholders Proxy Statement752 Part IV. Item 15. Exhibits, Financial Statement Schedules This section lists the financial statements and exhibits filed with or incorporated into the report - Lists the consolidated financial statements of Oncocyte Corporation filed in the Form 10-K755 - Includes a table of exhibits detailing various agreements (e.g., At-The-Market Sales Agreement, Merger Agreements for Insight and Chronix, Sublicense and Distribution Agreement, Loan and Security Agreement, Collaboration Agreement with Life Technologies Corporation), corporate documents, and security instruments755756758759761 - Many exhibits are incorporated by reference from previous SEC filings755756758759761 Item 16. Summary This item is not applicable and contains no summary information - None763 Signatures The report is duly signed and authorized by the company's executive officers and directors - The report is signed by Ronald Andrews (President and CEO), Mitchell Levine (CFO), Li Yu (VP and Controller), and several Directors767768 - The report was duly authorized and signed on March 11, 2022766768