Bionano Genomics, Inc. (NASDAQ:BNGO) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Amy Conrad - Investor Relations Erik Holmlin - Chief Executive Officer Chris Stewart - Chief Financial Officer Conference Call Participants Michael Okunewitch - Maxim Group Operator Good day, and welcome to the Bionano Genomics First Quarter 2022 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Amy Conrad from Investor Rel ...

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, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO | --- | --- | --- | |--- ...

Summary of Bionano Genomics, Inc. Conference Call Company Overview - **Company**: Bionano Genomics, Inc. (NASDAQ:BNGO) - **Industry**: Genomics and Biotechnology - **Technology**: Optical Genome Mapping (OGM) Key Points and Arguments 1. **Commercial Progress**: Bionano Genomics achieved $80 million in revenues for the previous year and installed 164 Saphyr systems, exceeding their goal of 150, representing a 65% year-over-year growth in the installed base [4][33] 2. **Adoption of Technology**: The company doubled the number of consumable flow cells sold, indicating a growing adoption of their methodology and systems for in-house genome analysis [4] 3. **Acquisition of BioDiscovery**: The acquisition of BioDiscovery, which developed the NxClinical software, is aimed at integrating optical genome mapping data with next-generation sequencing, enhancing customer experience and driving commercial adoption [5] 4. **Complementarity with Sequencing**: Bionano emphasizes that OGM complements rather than competes with next-generation sequencing, providing a more comprehensive view of the genome [5][11] 5. **Resolution Improvement**: OGM increases the resolution of structural variation detection from 5 million base pairs (karyotyping) to 500 base pairs, which is critical for cancer testing and genetic diseases [10] 6. **Clinical Utility**: The technology has been shown to find significantly more pathogenic variants, with studies indicating double-digit percentage increases in detection rates compared to traditional methods [21] 7. **Workflow Automation**: NxClinical automates the integration of optical genome mapping with sequencing, significantly speeding up the process of generating reportable results [19] 8. **Future of Cytogenetics**: Bionano positions OGM as the future of cytogenetics, suggesting it will replace traditional methods like karyotyping and FISH in many applications [25][28] 9. **Market Focus**: The company is targeting academic medical centers for adoption, emphasizing the need for reimbursement pathways to facilitate broader use of OGM [30] 10. **2022 Goals**: Bionano aims to increase the installed base from 164 to 240 systems by the end of 2022 and is focusing on obtaining a Category One CPT code for reimbursement [33] Additional Important Content - **Clinical Testing Challenges**: 50% to 70% of clinical tests for genetic diseases and cancer return no pathogenic variant findings, highlighting the need for higher resolution methods like OGM [21] - **Real-World Applications**: Examples from clinical settings, such as the Children's Hospital of LA, demonstrate how OGM can identify druggable targets in pediatric cancers that traditional sequencing might miss [22][23] - **Integration of Technologies**: The integration of OGM with existing workflows is seen as a way to streamline processes and improve diagnostic capabilities in laboratories [27][30] This summary encapsulates the key insights and developments discussed during the conference call, highlighting Bionano Genomics' strategic direction and the potential impact of its technology in the genomics field.

Bionano Genomics, Inc. (NASDAQ:BNGO) Q4 2021 Earnings Conference Call March 1, 2022 4:30 PM ET Company Participants Amy Conrad – Investor Relations Erik Holmlin – Chief Executive Officer Chris Stewart – Chief Financial Officer Conference Call Participants Sung Ji Nam – BTIG Destiny Buch – Ladenburg Thalmann Kevin DeGeeter – Oppenheimer Michael Okunewitch – Maxim Group Operator Good day, and welcome to the Bionano Genomics Fourth Quarter and Full Year 2021 Earnings Conference Call. Today’s conference is bein ...

Table of Contents 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM Commission File Number 001-38613 Bionano Genomics, Inc. | --- | --- | |-------------------------------------------------------------------------- ...

Bionano Genomics, Inc. (NASDAQ:BNGO) Q3 2021 Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Amy Conrad - Investor Relations Erik Holmlin - Chief Executive Officer Chris Stewart - Chief Financial Officer Rich Shippy - CBO Conference Call Participants Destiny Buch - Ladenburg Thalmann Kevin DeGeeter - Oppenheimer Operator Good day, and welcome to the Bionano Genomics' Third Quarter 2021 Earnings Conference Call. Today's conference is being recorded. At this time, I'd like to turn th ...

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, 2021 ☐ 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, 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 ...

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

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.