Bionano Genomics(BNGO)

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Bionano Genomics(BNGO) - 2021 Q2 - Earnings Call Transcript
2021-08-05 02:12
Bionano Genomics, Inc. (NASDAQ:BNGO) Q2 2021 Earnings Conference Call August 4, 2021 4:30 PM ET Company Participants Amy Conrad – Investor Relations Erik Holmlin – Chief Executive Officer Alka Chaubey – Chief Medical Officer Chris Stewart – Chief Financial Officer Conference Call Participants Sung Ji Nam – BTIG Jeffrey Cohen – Ladenburg Thalmann Jason McCarthy – Maxim Group Susan Chor – Oppenheimer Operator Good day, and welcome to the Bionano Genomics Second Quarter 2021 Earnings Conference Call. Today’s c ...
Bionano Genomics(BNGO) - 2021 Q2 - Quarterly Report
2021-08-03 16:00
PART I. FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021, and 2020, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, along with accompanying notes detailing accounting policies, revenue recognition, debt, equity transactions, and the acquisition of Lineagen [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (as of June 30, 2021 vs. December 31, 2020) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $332.6M | $38.4M | | Total current assets | $342.0M | $46.8M | | Total assets | $356.8M | $60.5M | | **Liabilities & Equity** | | | | Total current liabilities | $10.7M | $8.9M | | Long-term debt | $0 | $16.3M | | Total liabilities | $10.9M | $25.4M | | Total stockholders' equity | $345.9M | $35.1M | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (Unaudited) | Metric | 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** | **$3.9M** | **$1.2M** | **$7.0M** | **$2.3M** | | Loss from operations | $(16.5M) | $(7.4M) | $(27.6M) | $(17.2M) | | **Net Loss** | **$(18.8M)** | **$(8.1M)** | **$(28.7M)** | **$(18.6M)** | | Net loss per share | $(0.07) | $(0.09) | $(0.11) | $(0.29) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) - Total stockholders' equity increased significantly from **$35.1 million** at the start of 2021 to **$345.9 million** at June 30, 2021, primarily driven by the issuance of common stock from public offerings, which raised net proceeds of approximately **$327.5 million** in the first quarter[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for the Six Months Ended June 30 | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26.3M) | $(15.3M) | | Net cash provided by (used in) investing activities | $50,000 | $0 | | Net cash provided by financing activities | $320.4M | $15.1M | | **Net increase (decrease) in cash** | **$294.1M** | $(0.1M) | | Cash at end of period | $332.6M | $17.2M | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations for the financial statements, covering the company's business description, liquidity position, impact of COVID-19, revenue breakdown by source and geography, debt extinguishment, significant equity offerings, and details of the Lineagen acquisition - The company believes its cash and cash equivalents of approximately **$332.6 million** as of June 30, 2021, will be sufficient to fund operations for at least the next twelve months[27](index=27&type=chunk)[28](index=28&type=chunk) Revenue by Source (Six Months Ended June 30) | Revenue Source | 2021 | 2020 | | :--- | :--- | :--- | | Instruments | $2.0M | $0.8M | | Consumables | $2.5M | $1.2M | | Service and other | $2.5M | $0.4M | | **Total Revenue** | **$7.0M** | **$2.3M** | - In Q2 2021, the company paid off its term loan with Innovatus in full for a total of **$17.0 million**, which included an end-of-term fee and a prepayment fee, resulting in a loss on debt extinguishment of **$2.1 million**[55](index=55&type=chunk)[111](index=111&type=chunk) - In January 2021, the company completed two underwritten public offerings, raising combined gross proceeds of approximately **$331.8 million**[59](index=59&type=chunk)[60](index=60&type=chunk) - The company acquired Lineagen in August 2020 for an estimated total purchase price of **$7.14 million**, consisting of cash, stock, and assumed liabilities, providing a platform for accelerating sales growth for the Saphyr system[75](index=75&type=chunk)[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management provides an overview of the business, recent operational highlights, and the impact of COVID-19, analyzing financial results for the three and six months ended June 30, 2021, compared to 2020, covering revenue, cost of revenue, operating expenses, and liquidity drivers [Overview & Recent Highlights](index=18&type=section&id=Overview%20%26%20Recent%20Highlights) - Key operational metrics for Q2 2021 showed strong growth compared to Q2 2020: - **Saphyr Systems Shipped:** 13 (vs. 6) - **Total Installed Base:** 121 (vs. 87) - **Nanochannel Flow Cells Sold:** 2,742 (118% increase) - **Samples Analyzed in Service Lab:** 190 (vs. 77)[91](index=91&type=chunk)[92](index=92&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of operating results for the three and six-month periods ending June 30, 2021 and 2020, breaking down significant increases in revenue, driven by product sales and Lineagen services, and explaining the corresponding rise in cost of revenue and operating expenses due to increased sales volume, headcount growth, and higher compensation costs Q2 2021 vs Q2 2020 Performance | Metric | Q2 2021 | Q2 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | $3.9M | $1.2M | +226.2% | | Cost of Revenue | $2.4M | $0.6M | +300.8% | | R&D Expenses | $4.1M | $2.4M | +70.2% | | SG&A Expenses | $13.8M | $5.6M | +146.4% | | Loss from Operations | $(16.5M) | $(7.4M) | +121.6% | - The **226.2%** increase in Q2 2021 revenue was driven by higher demand for the reagent rental program and consumables, as well as **$1.1 million** in service revenue from the Lineagen subsidiary[106](index=106&type=chunk) - The **146.4%** increase in Q2 2021 SG&A expenses was primarily due to a **133%** increase in headcount (over half from Lineagen), higher compensation costs (including a **$1.4 million** increase in stock-based compensation), and a **$1.9 million** increase in professional services[110](index=110&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's financial position, sources of liquidity, and cash flow activities, noting **$332.6 million** in cash as of June 30, 2021, primarily from significant equity offerings, which management believes is sufficient to fund operations for at least the next year, also discussing debt extinguishment and PPP loan forgiveness - As of June 30, 2021, the company had approximately **$332.6 million** in cash and cash equivalents and working capital of **$331.2 million**[132](index=132&type=chunk) - Net cash provided by financing activities was **$320.4 million** for the first six months of 2021, primarily from two follow-on offerings and ATM sales that raised approximately **$328.6 million** in gross proceeds[127](index=127&type=chunk) - The company's **$1.8 million** PPP Loan was forgiven in full in March 2021[129](index=129&type=chunk) - Management believes the current cash balance is sufficient to fund operations, obligations, and capital investments for at least the next twelve months[139](index=139&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that as a smaller reporting company, it is not required to provide the information typically disclosed under this item - As a smaller reporting company, Bionano is exempt from providing detailed disclosures about market risk[144](index=144&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures and concluded they were not effective as of June 30, 2021, due to a previously reported material weakness in internal control over financial reporting, specifically an insufficient number of resources and inadequate segregation of duties, with remediation efforts underway but not yet complete - Management concluded that disclosure controls and procedures were not effective as of June 30, 2021[147](index=147&type=chunk) - A material weakness in internal control over financial reporting was identified, stemming from an insufficient number of resources and inadequate segregation of duties, though this weakness did not result in any identified material misstatements[148](index=148&type=chunk)[149](index=149&type=chunk) - Remediation efforts are in process, including engaging external consultants and hiring a new Chief Financial Officer and other senior accounting personnel, but the material weakness has not yet been fully remediated[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and a list of exhibits [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a defendant in any material legal proceedings - The company states it has no material legal proceedings[155](index=155&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive list of risks and uncertainties that could materially affect the company's business, financial condition, and operating results, including a history of net losses, reliance on market acceptance of the Saphyr system, competition, dependence on key suppliers, potential regulatory hurdles, intellectual property protection, and risks associated with being an emerging growth company with identified material weaknesses in internal controls - The company has a history of recurring net losses (**$28.7 million** in H1 2021) and expects to incur future losses as it invests in commercial expansion and R&D[161](index=161&type=chunk) - The business is adversely affected by public health crises like COVID-19, which impacts operations, customer demand, and supply chains[167](index=167&type=chunk) - The company's products are currently for "Research Use Only" (RUO), and if the FDA determines they are medical devices, it would require expensive and time-consuming regulatory clearance, which could materially harm the business[185](index=185&type=chunk)[222](index=222&type=chunk) - The company relies on single contract manufacturers for its Saphyr instruments and chip consumables, posing a significant supply chain risk[187](index=187&type=chunk) - A material weakness in internal control over financial reporting has been identified and is being remediated, and failure to maintain effective controls could lead to a loss of investor confidence[271](index=271&type=chunk) - The company will cease to be an "emerging growth company" effective December 31, 2021, which will increase compliance costs and require adherence to stricter reporting standards[269](index=269&type=chunk)[270](index=270&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company indicates this item is not applicable - Not applicable for this reporting period[284](index=284&type=chunk) [Item 3. Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[284](index=284&type=chunk) [Item 4. Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company indicates this item is not applicable - Not applicable[284](index=284&type=chunk) [Item 5. Other Information](index=67&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - None[284](index=284&type=chunk) [Item 6. Exhibits](index=68&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the 10-Q report, including the company's certificate of incorporation, bylaws, forms of stock and warrant certificates, and officer certifications required by the Sarbanes-Oxley Act - Lists filed exhibits, including officer certifications (31.1, 31.2, 32.1) and corporate governance documents[285](index=285&type=chunk) [Signatures](index=69&type=section&id=SIGNATURES) This section contains the required signatures for the filing
Bionano Genomics, Inc. (BNGO) CEO Erik Holmlin Presents at Oppenheimer MedTech, Tools & Diagnostics Summit Conference (Transcript)
2021-05-26 15:29
Key Points Company and Industry Overview * **Company**: Bionano Genomics, Inc. (NASDAQ:BNGO) * **Industry**: Genomics, specifically genome structure analysis and optical genome mapping * **CEO**: Erik Holmlin * **Focus**: Developing and commercializing optical genome mapping technology for structural variation analysis Core Views and Evidence * **Genomics Landscape**: Genomics has driven significant healthcare disruption and value creation over the past 20 years, primarily driven by advancements in technology like microarrays and next-generation sequencing. * **Next Wave of Innovation**: The next wave of innovation in genomics is in genome structure analysis, which Bionano Genomics is leading with its optical genome mapping technology. * **Business Performance**: Bionano Genomics had a strong start to 2021, with key achievements in expanding its installed base, commercial offerings, and market presence. * **Market Development**: Bionano Genomics is focusing on market development through publications, assay development, and reimbursement pathways. * **Saphyr System**: The Saphyr system is a key product for Bionano Genomics, offering optical genome mapping capabilities for structural variation analysis. * **Clinical Studies**: Bionano Genomics is conducting clinical studies to demonstrate the performance of the Saphyr system compared to traditional methods. * **Lineagen Acquisition**: The acquisition of Lineagen in August 2020 has provided Bionano Genomics with additional capabilities and revenue streams. Other Important Points * **Structural Variation**: Structural variation refers to changes in the location and amount of functional elements in the genome, and is an important factor in genetic diseases and cancer. * **Saphyr System Advancements**: Bionano Genomics has introduced new capabilities to the Saphyr system, including increased speed and throughput. * **Financial Results**: Bionano Genomics reported total revenues of $3.2 million in the first quarter of 2021, up 180% year-over-year. * **Capital Structure**: Bionano Genomics raised $337 million in January 2021, ending the quarter with a strong cash position of $362 million. * **Future Milestones**: Bionano Genomics expects to achieve key milestones in 2021, including assay accreditation, clinical study results, and expansion of the installed base.
Bionano Genomics(BNGO) - 2021 Q1 - Earnings Call Transcript
2021-05-14 02:55
Bionano Genomics, Inc. (NASDAQ:BNGO) Q1 2021 Results Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Amy Conrad - Investor Relations, Juniper Point Erik Holmlin - President and Chief Executive Officer Alka Chaubey - Chief Medical Officer Christopher Stewart - Chief Financial Officer Conference Call Participants Kevin DeGeeter - Oppenheimer & Co. Destiny Hance - Ladenburg Thalmann Michael Okunewitch - Maxim Group Operator Good day and welcome to the Bionano Genomics First Quarter 2021 E ...
Bionano Genomics(BNGO) - 2021 Q1 - Quarterly Report
2021-05-12 16:00
Table of Contents 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 | --- | --- | --- | |------------------------------------------------------------------------------------------------|------------------------------- ...
Bionano Genomics(BNGO) - 2020 Q4 - Earnings Call Transcript
2021-03-24 02:53
Bionano Genomics, Inc. (NASDAQ:BNGO) Q4 2020 Earnings Conference Call March 23, 2021 4:30 PM ET Company Participants Amy Conrad - Investor Relations Erik Holmlin - President and Chief Executive Officer Chris Stewart - Chief Financial Officer Conference Call Participants Kevin DeGeeter - Oppenheimer Jason McCarthy - Maxim Group Jeffrey Cohen - Ladenburg Thalmann Scott Henry - ROTH Capital Operator Good day, and welcome to the Bionano Genomics Fourth Quarter and Year-End 2020 Earnings Conference Call. At thi ...
Bionano Genomics(BNGO) - 2020 Q4 - Annual Report
2021-03-22 16:00
Part I [Business](index=8&type=section&id=Item%201.%20Business) Bionano Genomics specializes in optical genome mapping with its Saphyr system and provides diagnostic services for neurodevelopmental disorders [Overview](index=8&type=section&id=Item%201.%20Business%20-%20Overview) Bionano Genomics offers OGM solutions and diagnostic services, with Saphyr system installations growing to **97** in 2020, despite a **$1.6 million** revenue impact from COVID-19 - The company's core business revolves around the **Saphyr® system** for **optical genome mapping (OGM)** and diagnostic testing services for neurodevelopmental disabilities via its subsidiary, **Lineagen**[20](index=20&type=chunk) - The installed base of Saphyr systems increased by **24 units** in 2020, reaching a total of **97 systems** by year-end[25](index=25&type=chunk) - The COVID-19 pandemic caused a revenue decrease of approximately **$1.6 million** in 2020 compared to 2019, attributed to lab shutdowns and operational restrictions[24](index=24&type=chunk) - In January 2021, Bionano raised approximately **$350 million** in gross proceeds from two public offerings of its common stock[33](index=33&type=chunk) [Market Opportunity](index=11&type=section&id=Item%201.%20Business%20-%20Market%20Opportunity) The total addressable market for Bionano's Saphyr system and Lineagen's diagnostic services is estimated between **$4.4 billion** and **$5.7 billion** - The total addressable market for the Saphyr system and consumables is estimated to be between **$2.7 billion** and **$3.5 billion**[42](index=42&type=chunk) - The serviceable addressable market (SAM) for Lineagen's first-line genetic testing services for neurodevelopmental disorders is estimated to be between **$1.7 billion** and **$2.2 billion** in the United States[43](index=43&type=chunk) [Commercial Offerings](index=13&type=section&id=Item%201.%20Business%20-%20Commercial%20Offerings) Bionano's offerings include the Saphyr OGM system with consumables and software, alongside Lineagen's LDTs for neurodevelopmental disorders - The Saphyr system is a complete sample-to-result solution for structural variation analysis, comprising the Saphyr instrument, Saphyr Chip consumables, Bionano Prep Kits, and data solutions including Bionano Access software[44](index=44&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk)[53](index=53&type=chunk) - The end-user cost per sample is expected to decline from under **$500** in 2020 to approximately **$100** in 2023, with throughput expected to increase from **12** to **192** human samples per day in the same period[44](index=44&type=chunk) - Lineagen offers a suite of LDTs for pediatric neurodevelopmental disorders, including Chromosomal Microarray (CMA), Fragile X, Whole Exome Sequencing (WES), and Pharmacogenetics (PGx) testing[71](index=71&type=chunk) [Sales and Marketing](index=22&type=section&id=Item%201.%20Business%20-%20Sales%20and%20Marketing) Bionano employs a direct sales force and distributors for OGM, with a long sales cycle, while diagnostic services target pediatric specialists and secure insurance contracts covering **90 million** lives - The OGM commercial team comprises **72** people, with a direct sales force in North America and Europe, and distributors in Asia-Pacific and other regions[82](index=82&type=chunk) - The sales cycle for the Saphyr system is lengthy, typically **9 to 12 months**, due to the capital investment and customer evaluation process[82](index=82&type=chunk) - The diagnostic services commercial team has **4** people and targets pediatric specialists. As of year-end 2020, the company had insurance contracts covering approximately **90 million** lives in the U.S[83](index=83&type=chunk) [Manufacturing and Supply](index=23&type=section&id=Item%201.%20Business%20-%20Manufacturing%20and%20Supply) Bionano outsources Saphyr instrument and chip manufacturing, assembles reagents in-house, and utilizes third-party labs for diagnostic service wet lab work - The Saphyr instrument and chip consumables are manufactured by third-party contractors, while reagent kits are assembled internally[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk) - Diagnostic services utilize outsourced components, including Illumina's CMA testing platforms, and contract with third-party labs for wet work, while Bionano handles data interpretation and reporting under its own CLIA license[88](index=88&type=chunk) [Government Regulation](index=26&type=section&id=Item%201.%20Business%20-%20Government%20Regulation) Bionano's RUO products and LDT diagnostic services are subject to extensive regulation, including potential FDA oversight and complex reimbursement requirements - The company's OGM products are currently labeled "For Research Use Only" (RUO). If the FDA determines they are intended for clinical diagnostic use, they would require regulatory clearance (510(k)) or approval (PMA)[100](index=100&type=chunk)[188](index=188&type=chunk) - The company's diagnostic services are provided as Laboratory Developed Tests (LDTs), which are regulated under CLIA. The FDA has authority over LDTs but has historically exercised enforcement discretion[107](index=107&type=chunk)[190](index=190&type=chunk) - The company is subject to numerous healthcare regulations, including CLIA, HIPAA, state laboratory licensing laws, and federal/state anti-kickback and fraud and abuse laws[202](index=202&type=chunk)[203](index=203&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including recurring net losses, uncertain profitability, reliance on single-source manufacturers, intense competition, and complex regulatory and reimbursement landscapes [Risks related to our financial condition and need for additional capital](index=42&type=section&id=Item%201A.%20Risk%20Factors%20-%20Financial%20Condition%20and%20Capital) The company has a history of recurring net losses, reported a **$41.1 million** net loss in 2020, and faces uncertainty regarding future profitability and capital needs, alongside restrictive debt covenants - The company has a history of recurring net losses, reporting a net loss of **$41.1 million** for the year ended December 31, 2020, and an accumulated deficit of **$143.7 million**[144](index=144&type=chunk) - The business has been adversely affected by the COVID-19 pandemic, which has disrupted operations, impacted productivity, and may continue to negatively affect demand and financial results[148](index=148&type=chunk) - The company's debt facility with Innovatus contains restrictive covenants. The company was not in compliance with the revenue covenant for Q3 2020 and has previously breached covenants, requiring waivers and fees to avoid default[146](index=146&type=chunk)[153](index=153&type=chunk) [Risks related to our business operations](index=48&type=section&id=Item%201A.%20Risk%20Factors%20-%20Business%20Operations) Key business risks include achieving market acceptance, reliance on single-source manufacturers, long sales cycles, intense competition, and cybersecurity threats - Market acceptance of the Saphyr system is a key risk, as potential customers may be reluctant to replace their existing, long-used research systems[155](index=155&type=chunk) - The company relies on a single contract manufacturer for its Saphyr instruments and a single contract manufacturer for its chip consumables, posing a significant risk to supply continuity[170](index=170&type=chunk) - The life sciences research and diagnostic markets are highly competitive, with competitors including Pacific Biosciences, Oxford Nanopore, and 10x Genomics, many of whom have greater financial and human resources[183](index=183&type=chunk) [Risks related to government regulation and diagnostic product reimbursement](index=62&type=section&id=Item%201A.%20Risk%20Factors%20-%20Government%20Regulation%20and%20Reimbursement) Significant regulatory risks include potential FDA oversight of RUO products and LDTs, and the uncertainty of obtaining favorable reimbursement for diagnostic tests - A primary risk is the potential for the FDA to regulate the company's RUO products as medical devices, which would require costly and lengthy clearance or approval processes and could halt sales[188](index=188&type=chunk) - A significant change in how the FDA regulates Laboratory Developed Tests (LDTs) could substantially increase the cost and time to commercialize the company's diagnostic services and reduce demand from customer labs[190](index=190&type=chunk) - The company's and its customers' ability to generate revenue from diagnostic tests depends on obtaining and maintaining favorable coverage and reimbursement from government and private payors, which is complex and uncertain[195](index=195&type=chunk)[198](index=198&type=chunk) [Risks Related to Intellectual Property](index=68&type=section&id=Item%201A.%20Risk%20Factors%20-%20Intellectual%20Property) The company's success depends on protecting its intellectual property, which faces risks from patent challenges, competitor circumvention, reliance on licensed technology, and potential infringement lawsuits - The company relies on patent protection, but cannot guarantee that pending applications will issue as patents or that existing patents will not be challenged, invalidated, or circumvented by competitors[208](index=208&type=chunk) - A core part of the company's technology is licensed exclusively from Princeton University. A breach of this license agreement could lead to its termination, preventing the company from selling its products[210](index=210&type=chunk) - The company could be sued for infringing third-party intellectual property rights, which could result in costly litigation, substantial damages, and potentially block the sale of its products[213](index=213&type=chunk) [Unresolved Staff Comments](index=88&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments - None[248](index=248&type=chunk) [Properties](index=88&type=section&id=Item%202.%20Properties) The company leases its headquarters in San Diego and an office in Salt Lake City, anticipating future space needs for growth - The company leases its main facility of **35,823 sq. ft.** in San Diego, CA (lease expires Dec 2025) and a **9,710 sq. ft.** office in Salt Lake City, UT (lease expires Sep 2021)[249](index=249&type=chunk) [Legal Proceedings](index=88&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[250](index=250&type=chunk) [Mine Safety Disclosures](index=88&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable, as the company has no mine safety disclosures - None[251](index=251&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=89&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "BNGO", has approximately **90** record holders, and does not intend to pay cash dividends - Common stock trades on The Nasdaq Capital Market under the symbol "**BNGO**"[255](index=255&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[258](index=258&type=chunk) [Selected Financial Data](index=89&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, Bionano Genomics is not required to provide selected financial data - Not required as the company is a smaller reporting company[263](index=263&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=90&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In fiscal year 2020, total revenue decreased by **16%** to **$8.5 million**, net loss widened to **$41.1 million**, but liquidity significantly improved through recent equity offerings [Results of Operations](index=94&type=section&id=Item%207.%20MD%26A%20-%20Results%20of%20Operations) In 2020, total revenue decreased **16%** to **$8.5 million** due to lower instrument sales, while net loss widened to **$41.1 million** driven by increased operating expenses Results of Operations (2020 vs. 2019) | Metric | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | **$8,502,984** | **$10,129,508** | **($1,626,524)** | **(16)%** | | Instrument Revenue | $3,084,869 | $6,762,463 | ($3,677,594) | (54)% | | Consumable Revenue | $3,144,742 | $2,711,981 | $432,761 | 16% | | Service & Other Revenue | $2,273,373 | $655,064 | $1,618,309 | 247% | | **Total Cost of Revenue** | **$5,730,137** | **$6,768,147** | **($1,038,010)** | **(15)%** | | **Loss from Operations** | **($38,551,322)** | **($25,874,906)** | **($12,676,416)** | **49%** | | **Net Loss** | **($41,106,351)** | **($29,815,070)** | **($11,291,281)** | **38%** | | **Net Loss Per Share** | **($0.39)** | **($1.99)** | | | - Selling, general and administrative (SG&A) expenses increased by **$10.9 million (54%)** in 2020, due to headcount additions, increased legal/accounting fees, **$1.5 million** in transaction costs for the Lineagen acquisition, and a **$1.8 million** bad debt expense[287](index=287&type=chunk) [Liquidity and Capital Resources](index=95&type=section&id=Item%207.%20MD%26A%20-%20Liquidity%20and%20Capital%20Resources) The company experienced negative cash flow from operations in 2020 but significantly improved its liquidity position through substantial equity offerings in late 2020 and early 2021 Cash Flow Summary (2020 vs. 2019) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($38,314,378) | ($29,529,720) | | Net cash used in investing activities | ($2,449,952) | ($61,056) | | Net cash provided by financing activities | $61,901,667 | $30,379,420 | - As of December 31, 2020, the company had **$38.4 million** in cash and cash equivalents and an accumulated deficit of **$143.7 million**[289](index=289&type=chunk) - Subsequent to year-end, in January 2021, the company raised gross proceeds of approximately **$101.8 million** and **$230.0 million** from two separate underwritten public offerings[298](index=298&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=102&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Bionano Genomics is not required to provide market risk disclosures - Not required as the company is a smaller reporting company[320](index=320&type=chunk) [Financial Statements and Supplementary Data](index=103&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for 2020 and 2019, including balance sheets, income statements, cash flows, and detailed notes Consolidated Balance Sheet Summary (as of Dec 31) | | 2020 | 2019 | | :--- | :--- | :--- | | **Total Current Assets** | **$46,789,156** | **$28,258,241** | | Cash and cash equivalents | $38,448,710 | $17,311,373 | | **Total Assets** | **$60,449,526** | **$30,207,866** | | **Total Current Liabilities** | **$8,943,976** | **$26,367,021** | | **Total Liabilities** | **$25,367,352** | **$26,594,148** | | **Total Stockholders' Equity** | **$35,082,174** | **$3,613,718** | Consolidated Statement of Operations Summary (Year Ended Dec 31) | | 2020 | 2019 | | :--- | :--- | :--- | | **Total Revenue** | **$8,502,984** | **$10,129,508** | | **Total Cost of Revenue** | **$5,730,137** | **$6,768,147** | | **Total Operating Expenses** | **$41,324,169** | **$29,236,267** | | **Loss from Operations** | **($38,551,322)** | **($25,874,906)** | | **Net Loss** | **($41,106,351)** | **($29,815,070)** | | **Net Loss Per Share** | **($0.39)** | **($1.99)** | - In August 2020, the company acquired Lineagen, Inc. for consideration including approximately **$1.9 million** in cash and **6.17 million** shares of common stock, plus the assumption of **$2.9 million** in liabilities. The acquisition added **$7.2 million** in goodwill and **$1.6 million** in intangible assets[451](index=451&type=chunk)[453](index=453&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=137&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports that there were no changes in or disagreements with accountants on accounting and financial disclosure - None[456](index=456&type=chunk) [Controls and Procedures](index=137&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management identified a material weakness in internal control over financial reporting as of December 31, 2020, due to insufficient resources and inadequate segregation of duties, with remediation efforts underway - Management identified a material weakness in internal control over financial reporting as of December 31, 2020[459](index=459&type=chunk) - The weakness was due to an insufficient number of resources, leading to inadequate segregation of duties. This did not result in any identified material misstatements[459](index=459&type=chunk) - Remediation efforts include engaging external consultants and hiring additional qualified financial personnel to enhance internal controls[460](index=460&type=chunk)[462](index=462&type=chunk) [Other Information](index=139&type=section&id=Item%209B.%20Other%20Information) The company reported that on March 15, 2021, its Paycheck Protection Program (PPP) loan of approximately **$1.77 million**, received in April 2020, was forgiven in full by the Small Business Administration (SBA), including all accrued interest - The company's Paycheck Protection Program (PPP) loan of approximately **$1.77 million**, plus accrued interest, was forgiven in full by the SBA, effective March 15, 2021[464](index=464&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=140&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the 2021 Proxy Statement, and the company has adopted a code of business conduct and ethics - Information is incorporated by reference from the 2021 Proxy Statement[467](index=467&type=chunk) - The company has adopted a code of business conduct and ethics applicable to all employees, officers, and directors[468](index=468&type=chunk) [Executive Compensation](index=140&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the 2021 Proxy Statement - Information is incorporated by reference from the 2021 Proxy Statement[469](index=469&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=140&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the 2021 Proxy Statement - Information is incorporated by reference from the 2021 Proxy Statement[470](index=470&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=140&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the 2021 Proxy Statement - Information is incorporated by reference from the 2021 Proxy Statement[471](index=471&type=chunk) [Principal Accounting Fees and Services](index=140&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the 2021 Proxy Statement - Information is incorporated by reference from the 2021 Proxy Statement[472](index=472&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=141&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all documents filed as part of the Annual Report, including financial statements and an index of exhibits - This section provides an index of all exhibits filed with the Form 10-K, including material contracts and corporate governance documents[477](index=477&type=chunk)[478](index=478&type=chunk) [Form 10-K Summary](index=143&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None[482](index=482&type=chunk)
Bionano Genomics(BNGO) - 2020 Q3 - Quarterly Report
2020-11-13 00:29
Table of Contents 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, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file numb ...
Bionano Genomics(BNGO) - 2020 Q3 - Earnings Call Transcript
2020-11-12 23:52
Bionano Genomics, Inc. (NASDAQ:BNGO) Q3 2020 Results Conference Call November 12, 2020 4:30 PM ET Company Participants Ashley Robinson - IR Dr. Erik Holmlin - CEO Chris Stewart - CFO Conference Call Participants Kevin DeGeeter - Oppenheimer Jeffrey Cohen - Ladenburg Thalmann Scott Henry - ROTH Capital Operator Greetings. And welcome to Bionano Genomics Incorporated Third Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the form ...
Bionano Genomics(BNGO) - 2020 Q2 - Earnings Call Transcript
2020-08-14 01:15
Bionano Genomics, Inc. (NASDAQ:BNGO) Q2 2020 Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants Ashley Robinson - LifeSci Advisors Erik Holmlin - Chief Executive Officer Conference Call Participants Kevin DeGeeter - Oppenheimer Adheip Mally - Maxim Group Operator Greetings. And welcome to Bionano Genomics Inc. Second Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instru ...