Bionano Genomics(BNGO) - 2023 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents Bionano Genomics' unaudited condensed consolidated financial statements, showing a $76.0 million net loss for H1 2023, an accumulated deficit of $424.8 million, and a "going concern" warning Condensed Consolidated Financial Statements The financial statements show total assets decreased to $271.4 million by June 30, 2023, with a net loss of $38.9 million for Q2 2023 and $76.0 million for H1 2023, and $69.1 million cash used in operations Condensed Consolidated Balance Sheet (Unaudited) | Assets & Liabilities | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Total Current Assets | $122,575,000 | $157,298,000 | | Total Assets | $271,381,000 | $307,502,000 | | Total Current Liabilities | $33,499,000 | $35,884,000 | | Total Liabilities | $56,625,000 | $58,104,000 | | Total Stockholders' Equity | $214,756,000 | $249,398,000 | Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Total Revenue | $8,662,000 | $16,077,000 | | Loss from Operations | $(39,238,000) | $(77,083,000) | | Net Loss | $(38,912,000) | $(76,038,000) | | Net Loss Per Share | $(1.24) | $(2.46) | Condensed Consolidated Statements of Cash Flows (Unaudited, Six Months Ended) | Cash Flow Activity | June 30, 2023 | June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(69,109,000) | $(60,826,000) | | Net cash provided by investing activities | $46,104,000 | $63,204,000 | | Net cash provided by financing activities | $32,743,000 | $210,000 | Notes to Condensed Consolidated Financial Statements The notes detail the company's basis of presentation, significant accounting policies, and a key disclosure of substantial doubt about its going concern ability due to recurring losses, also breaking down revenue by source and geography, and outlining fair value measurements including a $24.6 million contingent consideration liability - The company has experienced recurring net losses, negative cash flows, and an accumulated deficit of $424.8 million as of June 30, 2023. Management has concluded there is substantial doubt about the company's ability to continue as a going concern[37] - On August 4, 2023, the company effected a 1-for-10 reverse stock split. All share and per-share amounts in the financial statements have been retroactively adjusted[385][393] Revenue by Source (Six Months Ended June 30) | Revenue Source | 2023 | 2022 | | :--- | :--- | :--- | | Instruments | $4,346,000 | $4,042,000 | | Consumables | $5,188,000 | $2,987,000 | | Software | $2,522,000 | $1,972,000 | | Total product revenue | $12,056,000 | $9,001,000 | | Service and other | $4,021,000 | $3,365,000 | | Total revenue | $16,077,000 | $12,366,000 | Revenue by Geographic Location (Six Months Ended June 30) | Region | 2023 | 2022 | | :--- | :--- | :--- | | Americas | $7,757,000 | $5,940,000 | | EMEA | $5,740,000 | $4,348,000 | | Asia Pacific | $2,580,000 | $2,078,000 | | Total | $16,077,000 | $12,366,000 | - The fair value of contingent consideration liabilities related to the BioDiscovery and Purigen acquisitions was $24.6 million as of June 30, 2023, measured using Level 3 inputs[86][87][185] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial performance, highlighting a 30% year-over-year revenue increase for Q2 2023 driven by 43% Saphyr system installed base growth, noting rising operating expenses led to a significant net loss, and emphasizing liquidity challenges with substantial doubt about going concern and a $20 million cost-reduction initiative Overview and Recent Highlights The company provides genome analysis solutions, with Q2 2023 highlights including a 43% year-over-year increase in Saphyr installed base to 281 systems and a 108% increase in flowcell sales to 7,062, while acknowledging geopolitical and macroeconomic risks - The installed base of Saphyr systems grew to 281 as of June 30, 2023, an increase of approximately 43% from 196 as of June 30, 2022[94] - The company sold 7,062 flowcells in Q2 2023, a 108% increase from 3,394 sold in Q2 2022. For the first six months of 2023, 12,288 flowcells were sold, an 86% increase from the same period in 2022[94] Results of Operations This section compares operating results for Q2 2023 and H1 2023 versus 2022, showing total revenue grew 30% in Q2 2023 with gross margin improving to 27%, but total operating expenses increased 24% to $41.5 million, resulting in a wider net loss of $38.9 million Comparison of Results of Operations (Three Months Ended June 30) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | $8,662,000 | $6,670,000 | 30% | | Product Revenue | $6,609,000 | $4,795,000 | 38% | | Total Cost of Revenue | $6,354,000 | $5,199,000 | 22% | | Gross Profit | $2,308,000 | $1,471,000 | 57% | | Gross Margin | 27% | 22% | - | | R&D Expenses | $14,610,000 | $11,767,000 | 24% | | SG&A Expenses | $26,936,000 | $21,783,000 | 24% | | Loss from Operations | $(39,238,000) | $(32,079,000) | 22% | - For the six months ended June 30, 2023, product revenue increased by 34% year-over-year, driven by increased demand for Saphyr OGM solutions and a 43% increase in the instrument installed base[156] - SG&A expenses for Q2 2023 increased by $5.2 million (24%) YoY, primarily due to higher compensation, amortization of intangibles from the Purigen acquisition, increased professional services, and a $1.4 million increase in the fair value of contingent consideration liabilities[173] Liquidity and Capital Resources The company has a history of net losses and negative cash flows, with an accumulated deficit of $424.8 million, leading to substantial doubt about its going concern ability as current cash and securities are insufficient for the next 12 months, prompting financing evaluations and a cost-saving plan, having raised $33.5 million via ATM in H1 2023 - The company has determined there is substantial doubt about its ability to continue as a going concern, as its available cash balance is not expected to be sufficient for the next twelve months[122][203] - As of June 30, 2023, the company had approximately $14.9 million in cash and cash equivalents and $62.2 million in available-for-sale securities[202] - In May 2023, the company announced a cost-reduction initiative to reduce cash expenditures by approximately $20.0 million over the next four to five quarters[203] - During the six months ended June 30, 2023, the company sold approximately 3.5 million shares of common stock under its Cowen ATM facility, receiving gross proceeds of approximately $33.5 million[184][206] Item 3. Quantitative and Qualitative Disclosures about Market Risk The company is exposed to market risks from interest rates, foreign currency exchange, and inflation, with a 100 basis point interest rate change estimated to have a $0.1 million impact, and foreign currency risk from international operations not considered material, while inflation has not yet materially affected operations - A hypothetical 100 basis point change in interest rates would have an approximate $0.1 million impact on the company's investments[190] - Foreign currency exposures are primarily concentrated in the British Pound, Chinese Renminbi, Euro, and Canadian dollar. A hypothetical 10% change in foreign exchange rates is not expected to have a material impact[191] - The company does not believe that inflation has had a material effect on its business or financial condition to date, but acknowledges risks if inflationary pressures increase[192] Item 4. Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of June 30, 2023, while actively integrating the internal controls of Purigen Biosystems, Inc., acquired in November 2022 - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[214] - The company is in the process of integrating the internal controls of Purigen Biosystems, Inc., acquired in November 2022[238] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports that it is not currently a defendant in any material claims or legal actions - The company is not currently a defendant in any claims or legal actions that are considered material[59][239] Item 1A. Risk Factors This section details numerous significant risks, including recurring losses and going concern doubt, dependence on market acceptance, intense competition, reliance on single-source manufacturers, significant FDA regulatory risks for "Research Use Only" products, acquisition integration challenges, intellectual property protection, and high stock price volatility - The company's recurring losses, negative cash flows, and significant accumulated deficit have raised substantial doubt about its ability to continue as a going concern[122][242] - The company relies on a single contract manufacturer for its OGM-based instruments and another single contract manufacturer for its chip consumables, creating significant supply chain risk[261][286] - The company's products are currently for "Research Use Only" (RUO). If the FDA were to determine these products are medical devices or if the company seeks diagnostic use, it would face an expensive, time-consuming, and uncertain regulatory clearance process[260][317] - The company's stock price has been and may continue to be highly volatile. A reverse stock split was implemented in August 2023, but it may not achieve its intended results, such as maintaining Nasdaq listing compliance[141][143] - The life sciences research and diagnostic markets are highly competitive, and the company faces competition from established companies with greater financial resources, brand recognition, and broader product lines[271] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section discloses the company's purchases of its own equity securities, specifically the repurchase of one share of Series A Preferred Stock for $100.00 in Q2 2023, which was issued to facilitate a stockholder vote and automatically redeemed Issuer Purchases of Equity Securities (Q2 2023) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 1 - April 30, 2023 | - | - | | May 1 - May 31, 2023 | - | - | | June 1 - June 30, 2023 | 1 | $100.00 | | Total | 1 | $100.00 | - The single share repurchased was a share of Series A Preferred Stock, which was issued on April 13, 2023, and automatically redeemed on June 14, 2023, following the Annual Meeting of Stockholders[79][97] Item 3. Defaults Upon Senior Securities The company reports that there were no defaults upon senior securities during the period - None[98] Item 4. Mine Safety Disclosures The company reports that this item is not applicable - Not applicable[131] Item 5. Other Information The company reports no other information for this item - None[131] Item 6. Exhibits This section lists exhibits filed with the 10-Q report, including corporate documents like the Amended and Restated Certificate of Incorporation, bylaws, and warrant forms, along with certifications from the Principal Executive Officer and Principal Financial Officer as required by Sarbanes-Oxley Act, and Inline XBRL data files - The report includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to SEC rules and the Sarbanes-Oxley Act of 2002[133] - Key corporate documents filed as exhibits include the Amended and Restated Certificate of Incorporation, bylaws, and various forms of warrants[133]