PART I. FINANCIAL INFORMATION Item 1. Unaudited Financial Statements This section presents the unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with their accompanying notes, providing a snapshot of the company's financial position and performance for the periods ended June 30, 2023 Condensed Balance Sheets The condensed balance sheets show a decrease in total assets and a shift in stockholders' equity from a positive balance to a deficit as of June 30, 2023, compared to December 31, 2022, primarily driven by a reduction in cash and an increase in current liabilities | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :--------------------------- | :------------------------------- | | Cash and cash equivalents | $7,127 | $14,603 | | Total current assets | $14,456 | $20,987 | | Total assets | $16,943 | $24,195 | | Total current liabilities | $22,443 | $17,946 | | Total liabilities | $23,533 | $20,049 | | Total stockholders' (deficit) equity | $(6,590) | $4,146 | Condensed Statements of Operations and Comprehensive Loss For the six months ended June 30, 2023, the company experienced a slight decrease in revenue and a reduced net loss compared to the same period in 2022, with an improved gross margin but increased R&D expenses | Metric (in thousands, except per share data) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $2,041 | $2,132 | $3,929 | $4,020 | | Gross profit | $605 | $657 | $1,241 | $1,181 | | Loss from operations | $(3,729) | $(3,759) | $(7,987) | $(8,455) | | Net loss and comprehensive loss | $(4,176) | $(4,214) | $(8,820) | $(9,354) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.59) | $(0.94) | $(1.30) | $(3.16) | Condensed Statements of Stockholders' Equity (Deficit) The company's stockholders' equity shifted from a positive balance to a deficit during the six months ended June 30, 2023, primarily due to the net loss and accretion of preferred stock dividends, partially offset by proceeds from common stock offerings | Item | Balance at December 31, 2022 (in thousands) | Balance at June 30, 2023 (in thousands) | | :---------------------------------------------------------------- | :------------------------------------------ | :-------------------------------------- | | Total Stockholders' Equity (Deficit) | $4,146 | $(6,590) | - Net and comprehensive loss for the six months ended June 30, 2023, was $(8,820) thousand, contributing to the accumulated deficit64 - Accretion of Series A preferred stock dividends totaled $(2,436) thousand for the six months ended June 30, 202364 Condensed Statements of Cash Flows For the six months ended June 30, 2023, net cash used in operating activities decreased, while net cash provided by financing activities significantly declined compared to the same period in 2022, leading to a larger net change in cash and cash equivalents | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(7,513) | $(10,547) | | Net cash used in investing activities | $0 | $(31) | | Net cash provided by financing activities | $37 | $7,120 | | Net change in cash and cash equivalents | $(7,476) | $(3,458) | | Cash and cash equivalents, end of period | $7,127 | $16,039 | Notes to Condensed Financial Statements These notes provide detailed explanations and additional information regarding the company's financial statements, covering its organization, liquidity, public offerings, significant accounting policies, inventory, borrowings, leases, commitments, stockholders' equity, and stock-based compensation 1. Organization, Nature of Business Avinger, Inc. designs, manufactures, and sells image-guided, catheter-based systems for treating peripheral artery disease (PAD) and is developing devices for coronary CTO markets, utilizing its Lumivascular platform with OCT visualization - Avinger, Inc. specializes in image-guided, catheter-based systems for Peripheral Artery Disease (PAD) treatment, featuring its Lumivascular platform with Optical Coherence Tomography (OCT) visualization96 - Key products include Ocelot and Tigereye for Chronic Total Occlusion (CTO) penetration, and Pantheris/Pantheris SV for atherectomy (plaque removal)96 - The company is also developing next-generation CTO crossing devices for the coronary CTO markets96 Liquidity Matters The company has a history of operating losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern, necessitating additional capital to fund operations beyond Q3 2023 and address Nasdaq listing requirements - As of June 30, 2023, the company had an accumulated deficit of $411.2 million and expects continued losses67 - Cash and cash equivalents of $7.1 million at June 30, 2023, are expected to fund operations only through Q3 2023, requiring additional equity or debt financing67 - Substantial doubt exists about the company's ability to continue as a going concern, leading to the classification of all outstanding borrowings as current liabilities6998 Public Offerings The company raised capital through a January 2022 offering of Series D Convertible Preferred Stock and Common Warrants ($6.7 million net proceeds), an August 2022 offering of common stock and pre-funded warrants ($4.4 million net proceeds), and an At The Market (ATM) Offering Agreement, which was reactivated in March 2023 - January 2022 Offering: Issued Series D Convertible Preferred Stock and Common Warrants, generating approximately $6.7 million in net proceeds70 - August 2022 Offering: Issued common stock and pre-funded warrants, resulting in approximately $4.4 million in net proceeds. All Private Placement Pre-Funded Warrants were exercised by June 30, 202372102 - At The Market (ATM) Offering Agreement: Reactivated on March 17, 2023, selling 101,720 shares for approximately $75,000 in proceeds during the six months ended June 30, 202374 2. Summary of Significant Accounting Policies The financial statements are prepared under U.S. GAAP, relying on management estimates for various items. The company faces credit risk from customer concentration and holds cash equivalents at a single institution. Product warranty costs are accrued based on historical data, and net loss per share calculations reflect anti-dilutive potential shares due to losses - Financial statements are prepared in accordance with U.S. GAAP, with management making significant estimates for stock-based compensation, accruals, valuation of warrants, doubtful accounts, and inventory106129 - Customer Concentration: As of June 30, 2023, two customers each represented 14% of accounts receivable, and one customer represented 16% of revenues for the six months ended June 30, 20231778 - Cash and cash equivalents are held at a single financial institution (First Citizens Bank, formerly Silicon Valley Bank), posing a concentration of credit risk5108 - Net loss per share is calculated as basic and diluted, with potentially dilutive securities excluded due to their anti-dilutive impact from reported losses110 3. Inventories Inventories increased to $5.519 million as of June 30, 2023, from $4.965 million at December 31, 2022, primarily driven by an increase in finished products | Inventory Component (in thousands) | June 30, 2023 | December 31, 2022 | | :--------------------------------- | :------------ | :---------------- | | Raw materials | $3,380 | $3,374 | | Work-in-process | $111 | $17 | | Finished products | $2,028 | $1,574 | | Total inventories | $5,519 | $4,965 | 4. Borrowings (CRG Loan) The CRG Loan Agreement, amended most recently in August 2022, extends the interest-only period through December 31, 2023, and the maturity date to December 31, 2025. It includes minimum liquidity and revenue covenants, with all outstanding borrowings classified as current due to substantial doubt about the company's going concern ability - The CRG Loan Agreement's interest-only period is extended through December 31, 2023, with the option to pay interest in kind (PIK)11138 - The Stated Maturity Date for the CRG Loan is extended to December 31, 202511138 - Minimum liquidity covenant is $3.5 million, and minimum revenue covenants are $10 million for 2023, $14.5 million for 2024, and $17 million for 202511138 - All outstanding borrowings under the CRG Loan ($15.2 million as of June 30, 2023) are classified as current due to substantial doubt about the company's ability to continue as a going concern11142 5. Leases The company's operating lease for office, laboratory, and manufacturing space expires on November 30, 2024, with remaining base rent payments of approximately $1.741 million. The right-of-use asset and lease liabilities are recorded at the present value of future payments - The operating lease for facilities expires on November 30, 2024, with a weighted average remaining lease term of 1.4 years as of June 30, 2023118 | Lease Obligation (in thousands) | Amount | | :------------------------------ | :----- | | 2023 (remaining six months) | $603 | | 2024 | $1,138 | | Total | $1,741 | | Lease-Related Assets and Liabilities (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------------------------------------- | :------------ | :---------------- | | Right of use asset | $1,658 | $2,194 | | Leasehold liability, current portion | $1,150 | $1,092 | | Leasehold liability, long-term portion | $508 | $1,102 | 6. Commitments and Contingencies As of June 30, 2023, the company had non-cancelable purchase commitments totaling approximately $1.0 million, primarily for inventory components and manufacturing services. There are no currently pending legal proceedings that are expected to have a material adverse effect - Non-cancelable purchase commitments amounted to approximately $1.0 million as of June 30, 2023, mainly for inventory components and manufacturing services120 - The company is not currently involved in any legal proceedings believed to have a material adverse effect on its financial condition, results of operations, or cash flows121 7. Stockholders' Equity The company's authorized capital includes convertible preferred stock and common stock. Series A preferred stock accrues 8% annual dividends, while Series D preferred stock was fully converted into common stock in 2022. Various warrants and preferred investment options to purchase common stock were outstanding, with August 2022 Pre-Funded Warrants fully exercised by June 30, 2023 - As of June 30, 2023, 60,961 shares of Series A preferred stock were outstanding, convertible into common stock at $400 per share, with $2.4 million in accrued dividends for the six months ended June 30, 2023178 - All 7,600 shares of Series D preferred stock were converted into 950,000 shares of common stock during 2022, with none outstanding as of June 30, 2023150 | Warrants and Options Outstanding | Total Outstanding and Exercisable (Shares) | Exercise Price per Share | Expiration Date | | :------------------------------- | :----------------------------------------- | :----------------------- | :-------------- | | Common Warrants (Jan 2022) | 807,500 | $9.60 | July 2027 | | Placement Agent Warrants (Jan 2022) | 66,500 | $10.00 | January 2027 | | Series A Preferred Investment Options (Aug 2022) | 2,853,883 | $1.502 | February 2028 | | Series B Preferred Investment Options (Aug 2022) | 2,853,883 | $1.502 | August 2024 | | Placement Agent Preferred Investment Options (Aug 2022) | 171,233 | $2.19 | August 2027 | - All August 2022 Pre-Funded Warrants (totaling 1,369,864 Private Placement Pre-Funded Warrants) were exercised during the six months ended June 30, 2023, with none outstanding155 8. Stock-Based Compensation The 2015 Equity Incentive Plan had 306,638 shares available for grant as of June 30, 2023. Total noncash stock-based compensation expense for RSAs and RSUs was $484,000 for the six months ended June 30, 2023, a significant increase from $88,000 in the prior year - As of June 30, 2023, 306,638 shares were available for grant under the 2015 Equity Incentive Plan159 | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cost of revenues | $35 | $7 | $63 | $14 | | Research and development expenses | $51 | $13 | $134 | $26 | | Selling, general and administrative expenses | $153 | $16 | $287 | $48 | | Total | $239 | $36 | $484 | $88 | - As of June 30, 2023, there was $1.3 million of remaining unamortized stock-based compensation expense for RSAs, to be expensed over approximately 1.5 years188 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results, highlighting business overview, recent product developments, challenges from hospital capacity and supply chain, financing activities, and a detailed comparison of financial performance for the three and six months ended June 30, 2023, versus 2022 Overview Avinger, Inc. is a medical device company focused on image-guided, catheter-based systems for Peripheral Artery Disease (PAD) treatment, with recent FDA clearances for Tigereye ST and Pantheris LV, and ongoing development for coronary CTO markets - Avinger designs, manufactures, and sells real-time high-definition image-guided, minimally invasive catheter-based systems for Peripheral Artery Disease (PAD) using its Lumivascular platform163191 - Received 510(k) clearance from the FDA for Tigereye Spinning Tip (ST) in April 2023, with a limited launch in Q2 2023 and full commercial availability expected in Q3 2023165 - Received 510(k) clearance from the FDA for Pantheris Large Vessel (LV) in June 2023, with a limited launch in Q3 2023 and full commercial availability expected in H2 2023193 - Ongoing clinical data programs include INSIGHT (for in-stent restenosis with Pantheris, FDA cleared in Nov 2021) and IMAGE-BTK (for below-the-knee lesions with Pantheris SV, enrollment expected to complete in 2023)168196 Recent Developments The company continues to face significant volatility in sales due to hospital staffing shortages and resource constraints. It also received Nasdaq delisting notices for failing to meet minimum bid price and stockholders' equity requirements, and is addressing global supply chain challenges. A 1-for-20 reverse stock split was effected in March 2022 - Hospital staffing shortages and resource constraints continue to cause significant volatility in sales and deferral of elective procedures199229 - Received Nasdaq notices for non-compliance with the Minimum Bid Price Requirement (below $1.00) and the $2.5 million Stockholders' Equity Requirement, facing potential delisting172230231 - Global supply chain disruptions, including material availability and extended lead times, may impair the ability to meet customer demand174233 - A 1-for-20 reverse stock split became effective on March 14, 2022, to address listing requirements175203 Financing The company's financing activities include the CRG Loan Agreement, which has been amended to extend interest-only payments and maturity, and the conversion of $38.0 million of the loan into Series A preferred stock in 2018 - The CRG Loan Agreement was amended in August 2022, extending the interest-only period through December 31, 2023, and the maturity date to December 31, 2025236 - The amendments also reduced the minimum liquidity covenant to $3.5 million and added minimum revenue covenants for 2023 ($10 million), 2024 ($14.5 million), and 2025 ($17 million)236 - In February 2018, $38.0 million of the CRG senior secured term loan was converted into Series A preferred stock, which accrues 8% annual dividends235 Components of Our Results of Operations This section outlines the key components influencing the company's financial results: revenues from PAD catheter sales, cost of revenues including manufacturing overhead and warranty costs, gross margin affected by production volumes and cost strategies, R&D expenses for product development and clinical trials, SG&A expenses for commercial and administrative functions, and interest/other income/expense - Revenues are primarily from PAD catheter sales in the U.S. and international markets, with expectations for increase in 2023 due to new product introductions (Tigereye ST, Pantheris LV) and easing hospital constraints237 - Cost of revenues includes manufacturing overhead, materials, direct labor, warranty costs, and inventory provisions, with overhead expected to decrease as a percentage of revenues with increased production208 - Gross margin is influenced by production volumes, manufacturing costs, product yields, and cost-reduction strategies, and is expected to fluctuate with new product introductions and manufacturing process changes209 - R&D expenses consist of engineering, product development, clinical and regulatory affairs, and are expected to vary based on new product development and clinical trial efforts210 - SG&A expenses cover sales, marketing, physician education, business development, and administrative functions, and are expected to increase with expanded commercial efforts211 Results of Operations: Comparison of Three Months Ended June 30, 2023 and 2022 For the three months ended June 30, 2023, revenue decreased by 4% due to hospital staffing shortages and sales team attrition. Gross margin slightly declined, R&D expenses decreased, and SG&A and net interest expenses remained flat compared to the same period in 2022 | Metric (in thousands, except percentages) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change ($) | Change (%) | | :---------------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Revenues | $2,041 | $2,132 | $(91) | -4% | | Cost of revenues | $1,436 | $1,475 | $(39) | -3% | | Gross profit | $605 | $657 | $(52) | -8% | | Gross margin | 30% | 31% | -1% | - | | Research and development | $988 | $1,086 | $(98) | -9% | | Selling, general and administrative | $3,346 | $3,330 | $16 | 0% | | Interest expense, net | $(445) | $(440) | $(5) | -1% | | Net loss and comprehensive loss | $(4,176) | $(4,214) | $38 | -1% | - Revenue decrease attributed to fluctuating demand from hospital staffing shortages and attrition/turnover of sales professionals242 - R&D expense decrease primarily due to completion of Tigereye ST and Pantheris LV development, partially offset by coronary device program development217 Results of Operations: Comparison of Six Months Ended June 30, 2023 and 2022 For the six months ended June 30, 2023, revenue decreased by 2% due to hospital staffing shortages and sales team attrition. Gross margin increased due to cost efficiencies and product mix. R&D expenses increased, while SG&A expenses decreased, and net interest expense remained flat compared to the same period in 2022 | Metric (in thousands, except percentages) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change ($) | Change (%) | | :---------------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Revenues | $3,929 | $4,020 | $(91) | -2% | | Cost of revenues | $2,688 | $2,839 | $(151) | -5% | | Gross profit | $1,241 | $1,181 | $60 | 5% | | Gross margin | 32% | 29% | 3% | - | | Research and development | $2,344 | $2,158 | $186 | 9% | | Selling, general and administrative | $6,884 | $7,478 | $(594) | -8% | | Interest expense, net | $(837) | $(879) | $42 | -5% | | Net loss and comprehensive loss | $(8,820) | $(9,354) | $534 | -6% | - Revenue decrease attributed to fluctuating demand from hospital staffing shortages and attrition/turnover of sales professionals1 - Gross margin increase primarily due to cost efficiencies, process optimization, and favorable product mix, partially offset by declines in economies of scale in Q2 2023248 - R&D expense increase primarily due to ongoing product development of the coronary device program, partially offset by completion of Tigereye ST and Pantheris LV development223 - SG&A expense decrease primarily due to lower sales personnel costs and third-party professional services, partially offset by increases in variable compensation249 Liquidity and Capital Resources The company has an accumulated deficit and expects to incur future losses, with current cash and equivalents sufficient only through Q3 2023, necessitating additional equity or debt financing. Cash flows for the six months ended June 30, 2023, show reduced operating cash burn but minimal financing proceeds compared to the prior year - As of June 30, 2023, cash and cash equivalents were $7.1 million, with an accumulated deficit of $411.2 million281 - Current cash and expected revenues are believed to be sufficient only through Q3 2023, requiring additional equity or debt financing for future operational needs and to regain Nasdaq compliance29281 - Net cash used in operating activities for the six months ended June 30, 2023, was $7.5 million, primarily due to net loss and increased net operating assets (prepaid expenses, inventory purchases)258 - Net cash provided by financing activities for the six months ended June 30, 2023, was less than $0.1 million, significantly lower than $7.1 million in the prior year, which included proceeds from preferred stock and warrants260290 Contractual Obligations The company's principal contractual obligations as of June 30, 2023, include operating lease payments, the CRG Loan, and non-cancelable purchase commitments, totaling $22.132 million | Obligation Type | Less Than 1 Year (in thousands) | 2-3 Years (in thousands) | 4-5 Years (in thousands) | More Than 5 Years (in thousands) | Total (in thousands) | | :------------------------------- | :------------------------------ | :----------------------- | :----------------------- | :------------------------------- | :------------------- | | Operating lease obligations | $1,224 | $517 | — | — | $1,741 | | CRG Loan | $4,637 | $14,747 | — | — | $19,384 | | Noncancelable purchase commitments | $989 | $18 | — | — | $1,007 | | Total | $6,850 | $15,282 | — | — | $22,132 | - The CRG Loan total of $19.384 million includes future accrued interest and a $2.2 million back-end fee due at maturity in December 2025286 - Operating lease obligations are for office, laboratory, and manufacturing space, expiring November 30, 2024286 Item 3. Quantitative and Qualitative Disclosures About Market Risk The company's market risks are primarily limited to credit risk from cash and cash equivalents held at a single financial institution, with minimal exposure to interest rate fluctuations due to short-term maturities and low-risk profiles, and negligible foreign currency risk - Credit risk is concentrated in cash and cash equivalents held at a single financial institution (First Citizens Bank), with deposits exceeding insured limits5261 - Interest rate risk is limited due to short-term maturities and low-risk profile of cash equivalents; a 100 basis point change would not materially affect fair value16 - Foreign currency risk is not expected to have a material effect, as business is primarily conducted in U.S. dollars262 Item 4. Controls and Procedures Management, under the supervision of the principal executive and financial officers, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2023, concluding they were effective. No material changes in internal controls over financial reporting were identified - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 202319263 - No material changes in internal controls over financial reporting occurred during the three months ended June 30, 2023264 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its financial condition, results of operations, or cash flows - No material legal proceedings are currently pending against the company292 Item 1A. Risk Factors This section updates previously disclosed risk factors, emphasizing the significant risks related to potential Nasdaq delisting due to non-compliance with bid price and stockholders' equity requirements, substantial doubt about the company's ability to continue as a going concern, restrictive covenants under the CRG Loan Agreement, and the challenge of securing additional financing - Nasdaq Delisting Risk: The company is not in compliance with the Minimum Bid Price Requirement ($1.00) and the $2.5 million Stockholders' Equity Requirement, facing potential delisting if compliance is not regained by October 23, 2023, and November 14, 2023, respectively267268293 - Going Concern Doubt: There is substantial doubt about the company's ability to continue as a going concern due to recurring operating losses and negative cash flows, requiring additional financing to execute its business plan35296 - CRG Loan Covenants: The Loan Agreement contains various covenants, including minimum liquidity ($3.5 million) and revenue targets ($10 million for 2023), which, if breached, could lead to default and acceleration of outstanding amounts298307 - Financing Challenges: Inability to secure additional financing on favorable terms could force delays or elimination of product development and commercialization efforts, or lead to insolvency, with potential for significant dilution to existing stockholders308309 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This item is not applicable to the current report - Not applicable301 Item 3. Defaults Upon Senior Securities There are no defaults upon senior securities to report - None276 Item 4. Mine Safety Disclosures There are no mine safety disclosures to report - None40 Item 5. Other Information There is no other information to report under this item - None310 Item 6. Exhibits This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and XBRL-related documents | Number | Exhibit Title | | :-------- | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 31.1 | Certification of the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 31.2 | Certification of the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 32.1* | Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 101.INS | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | | 101.SCH | Inline XBRL Taxonomy Extension Schema Document | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | 104 | Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | Signatures The report is duly signed on behalf of Avinger, Inc. by its Chief Executive Officer and Vice President, Finance, on July 27, 2023 - The report was signed by Jeffery M. Soinski, Chief Executive Officer, and Nabeel Subainati, Vice President, Finance (Principal Financial and Accounting Officer), on July 27, 20233444304
Avinger(AVGR) - 2023 Q2 - Quarterly Report