UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to _____________________________________________ Commission file number: 001-34180 FLUIDIGM CORPORATION (Exact name ...

Investor Overview September 2021 Legal Information Forward-looking statements This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding revenue growth and profitability targets, consumables and services recurring revenue growth expectations, market opportunities, expense management, productivity and efficiency goals, product innovation, Fluidigm's access ...

Supplemental Financial Information Q2 2021 August 5, 2021 Legal Information Forward-looking statements This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding revenue growth and profitability targets, consumables and services recurring revenue growth expectations, market opportunities, expense management, productivity and efficiency goals, product inno ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) The unaudited condensed consolidated financial statements for the period ended June 30, 2021, show a decrease in total assets to $289.3 million from $324.8 million at year-end 2020, primarily due to a reduction in cash and cash equivalents, with net loss widening to $36.0 million despite a 19% year-over-year increase in total revenue to $63.8 million for the six-month period Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Total current assets** | $78,206 | $117,663 | | **Total assets** | $289,315 | $324,757 | | **Total current liabilities** | $52,848 | $54,249 | | **Total liabilities** | $179,865 | $185,707 | | **Total stockholders' equity** | $109,450 | $139,050 | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | $31,018 | $26,058 | $63,812 | $53,675 | | **Loss from operations** | $(17,268) | $(13,726) | $(36,588) | $(28,668) | | **Net loss** | $(17,143) | $(13,015) | $(35,964) | $(28,995) | | **Net loss per share** | $(0.23) | $(0.18) | $(0.48) | $(0.41) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(27,565) | $(7,085) | | **Net cash provided by (used in) investing activities** | $(9,095) | $27,586 | | **Net cash provided by (used in) financing activities** | $(1,159) | $8 | | **Net (decrease) increase in cash** | $(37,657) | $20,304 | - The company has a contract with the National Institutes of Health (NIH) under the RADx program with a total value of up to **$34.0 million** to expand production capacity for COVID-19 testing[53](index=53&type=chunk) - As of June 30, 2021, the total value of milestones reasonably assured was **$31.4 million**, with a total deferred grant income of **$28.2 million**[68](index=68&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's analysis of financial results for Q2 and H1 2021 highlights a 19% year-over-year revenue increase for both periods, driven by strong growth in consumables and services, with expectations for lower cash usage in the second half of 2021 despite potential negative impacts on product and service margins due to product transition and mix [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Total revenue grew 19% year-over-year to $31.0 million for Q2 and $63.8 million for H1 2021, driven by a 30% increase in product and service revenue, though product and service margin decreased by 2.4 percentage points to 50.1% due to higher provisions for obsolete inventory and lower average selling prices Revenue by Source (in thousands) | Revenue Source | Three Months Ended June 30, 2021 | YoY Change | | :--- | :--- | :--- | | Instruments | $10,179 | 19% | | Consumables | $12,448 | 41% | | **Product revenue** | **$22,627** | **30%** | | **Service revenue** | **$6,627** | **29%** | | Development revenue | $850 | (72)% | | **Total revenue** | **$31,018** | **19%** | Revenue by Geographic Area (in thousands) | Geographic Area | Three Months Ended June 30, 2021 | YoY Change | | :--- | :--- | :--- | | Americas | $16,120 | 16% | | EMEA | $9,220 | 41% | | Asia-Pacific | $5,678 | 2% | | **Total revenue** | **$31,018** | **19%** | - Product and service margin decreased by **2.4 percentage points** for Q2 2021 compared to Q2 2020, falling to **50.1%**, primarily due to higher provisions for excess and obsolete inventory related to COVID-19 testing consumables, lower average selling prices of mass cytometry instruments, and higher service costs[176](index=176&type=chunk) - Operating expenses increased by **16%** in Q2 2021 compared to Q2 2020, with R&D expenses rising **12%** to **$9.4 million** and SG&A expenses increasing **18%** to **$24.2 million**, driven by higher compensation costs, consulting fees, and travel expenses[178](index=178&type=chunk)[180](index=180&type=chunk)[184](index=184&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company's principal liquidity sources were $30.9 million in cash and cash equivalents and $10.9 million available under its revolving credit facility, with net cash used in operating activities significantly increasing to $27.6 million for H1 2021, though management believes existing resources are sufficient for at least the next 18 months following a recent credit facility amendment Cash Flow Summary (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(27,565) | $(7,085) | | **Net cash provided by (used in) investing activities** | $(9,095) | $27,586 | | **Net cash provided by (used in) financing activities** | $(1,159) | $8 | - As of June 30, 2021, principal sources of liquidity consisted of **$30.9 million** of cash and cash equivalents and **$10.9 million** of availability under the Revolving Credit Facility[191](index=191&type=chunk)[213](index=213&type=chunk) - On August 2, 2021, the company amended its credit agreement, extending its **$15.0 million** Revolving Credit Facility to August 2, 2023, and adding a new **$10.0 million** Term Loan Facility, from which the company immediately drew a **$5.0 million** term loan advance[134](index=134&type=chunk)[151](index=151&type=chunk)[208](index=208&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks stem from fluctuations in foreign currency exchange rates and interest rates, with a majority of revenue denominated in U.S. dollars while expenses are incurred in various currencies, creating exposure to currency fluctuations, though interest rate risk is considered minimal - The company's results of operations and cash flows are subject to fluctuations due to changes in foreign currency exchange rates, as revenues are primarily in USD while expenses are in multiple currencies, and the company does not currently engage in foreign currency hedging[219](index=219&type=chunk)[220](index=220&type=chunk) - Interest rate risk is considered immaterial, as cash and cash equivalents are held in short-term deposits and money market funds, and a **10%** change in interest rates would not have materially affected interest income[221](index=221&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of June 30, 2021, the company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that as of June 30, 2021, the company's disclosure controls and procedures were effective at the reasonable assurance level[223](index=223&type=chunk) - There were no changes in the company's internal control over financial reporting during the six months ended June 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[224](index=224&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is a defendant in a putative class action lawsuit filed in September 2020, alleging violations of federal securities laws, for which the court granted the company's motion to dismiss with leave for the plaintiff to amend on August 4, 2021, and the company intends to vigorously defend the action - A putative class action complaint alleging federal securities law violations was filed against the company in September 2020, and the company's motion to dismiss was granted with leave to amend on August 4, 2021, with the company believing the claims are without merit and intending to defend the action vigorously[131](index=131&type=chunk)[229](index=229&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous significant risks that could adversely affect its business, including the ongoing impact of the COVID-19 pandemic, a history of incurring net losses, intense competition, reliance on single-source suppliers, potential manufacturing disruptions, the need to retain key personnel, regulatory uncertainty regarding "research use only" products, and financial risks from significant outstanding debt and uncertain future capital needs - The COVID-19 pandemic has significantly affected business operations, causing reduced demand for some products, operational inefficiencies, and supply chain disruptions, and while it created opportunities in diagnostics, the demand for COVID-19 testing products has slowed, leading to lowered revenue expectations for 2021[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - The company has a history of significant net losses, with an accumulated deficit of **$712.7 million** as of June 30, 2021, and may continue to incur substantial losses for the foreseeable future due to investments in R&D and sales and marketing[251](index=251&type=chunk) - The company relies on single and sole source suppliers for critical components, such as the specialized polymer for IFCs and the electron multiplier detector for Helios/Hyperion systems, and the loss of any of these suppliers could significantly disrupt production[279](index=279&type=chunk)[281](index=281&type=chunk) - The company's products, currently labeled as "research use only" (RUO), could become subject to stricter regulation as medical devices by the FDA, especially if customers use them in laboratory-developed tests (LDTs), and evolving FDA oversight of LDTs could adversely impact sales and require changes to the business model[319](index=319&type=chunk)[320](index=320&type=chunk)[323](index=323&type=chunk) - The company has a significant amount of outstanding debt, including **$55.0 million** of **5.25%** convertible senior notes due 2024, which requires cash flow for interest payments and limits financial flexibility[350](index=350&type=chunk)[354](index=354&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the reporting period - None [Defaults Upon Senior Securities](index=80&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the reporting period - None [Mine Safety Disclosures](index=80&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None [Other Information](index=80&type=section&id=Item%205.%20Other%20Information) The company reported no information required to be disclosed under this item - None [Exhibits](index=81&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to the NIH contract and lease agreements, new employment terms for an executive, the amended 2011 Equity Incentive Plan, an amendment to the loan and security agreement with Silicon Valley Bank, and required CEO/CFO certifications - The report includes a list of filed exhibits, such as amendments to the NIH contract, lease agreements, management compensation plans, and the Fourth Amendment to the Loan and Security Agreement with Silicon Valley Bank[395](index=395&type=chunk)[397](index=397&type=chunk)

_____________________________________________ Commission file number: 001-34180 FLUIDIGM CORPORATION UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Indicate by che ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 Address of principal executive offices Zip Code Registrant's telephone number, including area code: (650) 266-6000 _____________________________________________ or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...

Investor Presentation Q4 2020 February 10, 2021 Legal Information Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding revenue growth and opportunities, development and expansion of Fluidigm's diagnostic business, new product releases, additional collaborations and partnerships, benefits and increasing adoption and utilization of Fluidigm mass cytometry produc ...

Fluidigm Corporation (FLDM) Q4 2020 Earnings Conference Call February 10, 2021 5:00 PM ET Company Participants Agnes Lee - Vice President, Investor Relations Chris Linthwaite - President and Chief Executive Officer Vikram Jog - Chief Financial Officer Conference Call Participants Sung Nam - BTIG Dan Brennan - UBS Steven Mah - Piper Sandler Operator Ladies and gentlemen, thank you for standing by, and welcome to Fluidigm Fourth Quarter 2020 Financial Results. [Operator instructions] please be advised that ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $39.9 million, representing a 50% increase compared to Q3 2019, with product and service revenue of $35.3 million growing 34% year-over-year [33] - COVID-19 testing contributed $11 million to quarterly revenues, with over 90% of that revenue from diagnostic tests [34] - Product and service margin improved to 58.9% in Q3 2020 from 52.6% in the same period last year, driven by sales of COVID-19 diagnostic consumables [45][46] Business Line Data and Key Metrics Changes - Mass cytometry product and service revenue was $15.1 million, a decrease of 3% year-over-year, primarily due to lower instrument revenues [37] - Microfluidics product and service revenue increased by 88% year-over-year to $20.2 million, driven by COVID-19 testing revenue [39] - The company sold 795,000 tests in Q3, with average selling prices ranging from $5 to $20 [41] Market Data and Key Metrics Changes - Americas revenue grew 113% to $23.7 million, with product and service revenue increasing 75% to $19.1 million [42] - Asia Pacific revenue increased 17% to $7.4 million, while EMEA revenues declined by 3% to $8.8 million [43] - Foreign exchange rates had a 3% positive impact on EMEA revenues [44] Company Strategy and Development Direction - The company aims to shift from being a general-purpose research tools provider to a market-oriented solutions provider [16] - New partnerships and collaborations are critical for success, with a focus on expanding into larger markets and high-value customers [18] - The company is investing in understanding the immunome, which is expected to have a significant impact on healthcare [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth despite uncertainties due to COVID-19 outbreaks and regional lockdowns [28] - The company anticipates robust demand for COVID-19 testing in 2021, with a dynamic competitive landscape [23] - The long-term strategy includes updating planning to incorporate new opportunities and expanding manufacturing capacity [29] Other Important Information - Cash and cash equivalents at the end of Q3 2020 totaled $73.4 million, up from $46.5 million at the end of Q2 2020 [51] - The company has withdrawn its annual guidance due to uncertainties surrounding the ongoing COVID-19 pandemic [53] Q&A Session Summary Question: Insights on the trajectory from here regarding COVID - Management noted strong placements and expressed optimism about the ramp-up in testing volume, emphasizing that the pace depends on customer business models [70][72] Question: Backlog and visibility on mass cytometry - Management did not provide specific backlog numbers but indicated confidence in the pipeline and anticipated installations in Q4 [82][84] Question: Capacity to deliver tests and boxes - The company has increased manufacturing capacity to six million tests for Q4 and does not anticipate constraints on box availability [88][90] Question: Sales cycle into clinical labs - The sales cycle has been variable, with some opportunities closing within days, and there is a mix of industrial and academic customers [96][98] Question: Breakdown of tests sold - The majority of test sales were focused on the university segment, particularly due to large orders from universities [102][104]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Fluidigm Corporation's Q3 2020 financial statements reflect increased assets, revenue growth, and a narrowed net loss, alongside improved cash flow [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased by September 30, 2020, primarily due to cash growth, while total liabilities also rose Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $72,345 | $21,661 | | Total current assets | $122,663 | $96,096 | | Total assets | $322,977 | $264,812 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $42,791 | $32,821 | | Total liabilities | $171,004 | $111,200 | | Total stockholders' equity | $151,973 | $153,612 | | Total liabilities and stockholders' equity | $322,977 | $264,812 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 2020 revenue increased by **50%** to **$39.9 million**, leading to a significantly reduced net loss of **$6.0 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $39,861 | $26,496 | $93,536 | $84,803 | | Loss from operations | $(5,464) | $(13,816) | $(34,132) | $(42,658) | | Net loss | $(5,999) | $(12,887) | $(34,994) | $(52,105) | | Net loss per share | $(0.08) | $(0.19) | $(0.49) | $(0.79) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by **$49.6 million** for the nine months ended September 30, 2020, driven by investing and financing activities Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,684) | $(29,691) | | Net cash provided by (used in) investing activities | $40,797 | $(38,750) | | Net cash provided by financing activities | $20,425 | $1,006 | | Net increase (decrease) in cash | $49,624 | $(67,440) | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail significant accounting policies and events, including the InstruNor AS acquisition, NIH RADx grant, and an at-the-market equity offering - On January 17, 2020, the company acquired InstruNor AS for a purchase price of **$7.2 million**, which included **$5.2 million** in cash and **$2.0 million** in common stock. The **acquisition resulted in** **$2.2 million** of goodwill[76](index=76&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk) - The company executed a definitive contract with the **NIH** under the **RADx program** with a total value of up to **$34.0 million** to expand production capacity for **COVID-19** testing. As of September 30, 2020, milestones valued at **$18.6 million** were considered reasonably assured, resulting in **$18.2 million** of **deferred grant income**[81](index=81&type=chunk)[83](index=83&type=chunk) - In March 2020, the company entered into an OEM Supply and Development Agreement and recognized **$3.2 million** and **$6.2 million** of **development revenue** in the three and nine months ended September 30, 2020, respectively[160](index=160&type=chunk) - During the third quarter of 2020, the company sold **2.5 million shares** of common stock through an "**at-the-market**" offering, generating **net proceeds** of approximately **$20.1 million**[122](index=122&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q3 2020 revenue growth driven by COVID-19 demand and new agreements, alongside improved liquidity from equity offerings and grants [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Q3 2020 total revenue increased **50%** to **$39.9 million**, driven by product, development, and grant revenue, with improved product and service margins Revenue by Source (in thousands) | Revenue Source | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Instruments | $12,624 | $9,159 | 38% | | Consumables | $16,586 | $11,507 | 44% | | Service revenue | $6,131 | $5,630 | 9% | | Development revenue | $3,180 | $— | NA | | Grant revenue | $1,340 | $200 | 570% | | **Total revenue** | **$39,861** | **$26,496** | **50%** | Revenue by Geography (in thousands) | Geographic Area | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Americas | $23,653 | $11,112 | 113% | | EMEA | $8,837 | $9,092 | (3)% | | Asia-Pacific | $7,371 | $6,292 | 17% | | **Total revenue** | **$39,861** | **$26,496** | **50%** | - Product and service margin increased by **6.3 percentage points** for Q3 2020 compared to Q3 2019, driven by higher revenue base, favorable impact from **COVID-19**-related consumable products, and lower inventory reserve charges[213](index=213&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity improved significantly by September 30, 2020, with **$72.3 million** in cash, bolstered by financing and investing activities, including an ATM offering and NIH grant proceeds - Principal sources of liquidity as of September 30, 2020, consisted of **$72.3 million** of cash and cash equivalents and **$15.0 million** of availability under the **Revolving Credit Facility**[232](index=232&type=chunk) - Net cash from financing activities was **$20.4 million** for the nine months ended September 30, 2020, primarily due to **$20.2 million** in **net proceeds** from an **at-the-market (ATM) equity offering**[239](index=239&type=chunk) - Net cash from investing activities was **$40.8 million** for the nine months ended September 30, 2020, mainly from **$11.2 million** in proceeds from the **NIH RADx grant** and **$31.8 million** from maturities of investments[237](index=237&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks are foreign currency exchange rates and interest rates, though a **10% change** is not expected to be material - The company's main market risk exposures are from **foreign currency exchange rates**, as expenses are denominated in various currencies while most revenue is in U.S. dollars, and from **interest rate sensitivity** on its cash and cash equivalents[258](index=258&type=chunk) - The company does not currently engage in **hedging activities** for foreign currency risk. Management believes a **10% change** in foreign currency exchange rates or interest rates would not materially impact the financial statements[259](index=259&type=chunk)[260](index=260&type=chunk) [Item 4. Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed **effective** as of September 30, 2020, with no material changes to **internal control over financial reporting** - Management, including the CEO and CFO, concluded that as of September 30, 2020, the company's disclosure controls and procedures were **effective** at the reasonable assurance level[264](index=264&type=chunk) - No changes in **internal control over financial reporting** occurred during the third quarter of 2020 that have materially affected, or are reasonably likely to materially affect, internal controls[265](index=265&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) A **class action complaint** alleging federal securities law violations was filed against the company in September 2020, which the company intends to vigorously defend - A **class action complaint** was filed against the company in September 2020, alleging violations of federal securities laws. The company believes the claims are **without merit** and will defend itself vigorously[269](index=269&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the **COVID-19 pandemic's** impact, a history of losses, intense competition, supply chain reliance, and regulatory challenges for its **COVID-19** test and NIH contract - The global **COVID-19 pandemic** has **significantly affected** business operations, with impacts including reduced demand for some products, supply chain disruptions, and increased stock price volatility[273](index=273&type=chunk) - The company has a history of **significant losses**, with an **accumulated deficit** of **$658.7 million** as of September 30, 2020, and may continue to incur losses for the foreseeable future[281](index=281&type=chunk) - The FDA's **Emergency Use Authorization (EUA)** for the Advanta Dx SARS-CoV-2 RT-PCR Assay is **temporary** and will be terminated after the public health emergency, requiring a traditional, more burdensome regulatory pathway to continue sales[329](index=329&type=chunk) - The company's contract with the NIH is subject to **government contracting risks**, including termination for convenience, milestone-based funding, and compliance with **Federal Acquisition Regulations (FAR)**[333](index=333&type=chunk)[336](index=336&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=79&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) **No unregistered sales** of equity securities or use of proceeds were reported for the period - There were **no unregistered sales** of equity securities or use of proceeds to report for the period[407](index=407&type=chunk) [Item 3. Defaults Upon Senior Securities](index=79&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) **No defaults** upon senior securities were reported for the period - There were **no defaults** upon senior securities to report for the period[408](index=408&type=chunk) [Item 4. Mine Safety Disclosures](index=79&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable as the company has no mining operations - There were **no mine safety disclosures** to report for the period[409](index=409&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) **No other information** required to be disclosed under this item was reported - There was **no other information** to report for the period[410](index=410&type=chunk) [Item 6. Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including NIH contracts, license agreements, and CEO/CFO certifications