For the six months ended June 30, 2023, revenue decreased by approximately $0.1 million or 2% compared to the six months ended June 30, 2022. Our revenues reflect the fluctuating demand partially due to the adverse impacts of hospital staffing shortages as capacity limitations in hospitals have limited the ability of practitioners to perform elective surgical procedures using our products in certain jurisdictions. In addition, we have experienced and expect that we will continue to experience attrition and ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2023 was $1.9 million, unchanged from Q1 2022 and down from $2 million in Q4 2022 [24] - Gross margin improved to 34% from 28% in the year-ago quarter, stable compared to Q4 2022 [24] - Operating expenses decreased to $4.9 million from $5.2 million in the year-ago quarter and increased from $4.5 million in Q4 2022 [24] - Net loss for Q1 2023 was $4.6 million, compared to $5.1 million in Q1 2022 and $4.2 million in Q4 2022 [24] - Adjusted EBITDA loss was $3.9 million, an improvement from a loss of $4.6 million in Q1 2022 and a loss of $3.8 million in Q4 2022 [25] - Cash and cash equivalents totaled $10.4 million at the end of the quarter [25] Business Line Data and Key Metrics Changes - Sales productivity improved by over 25%, achieving the same revenue with a lower sales headcount [8] - Pantheris SV small vessel atherectomy device showed significant growth in procedures and revenue compared to the prior year [13] Market Data and Key Metrics Changes - The company is expanding its clinical sales force, having added two new clinical specialists with more expected to join [9] Company Strategy and Development Direction - The company aims to increase case coverage and catheter utilization through the expansion and training of its clinical sales team [22] - Plans to launch two new peripheral products in the second half of 2023, which will broaden the product portfolio and create new usage drivers [22] - The development of a coronary product application is underway, targeting a market with significant potential [18][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recent Tigereye ST clearance and the anticipated Pantheris LV launch, which are expected to drive growth [26] - The company is focused on leveraging clinical data to enhance product adoption and market penetration [31] Other Important Information - The company received 510(k) clearance for the Tigereye ST catheter and initiated limited launch activities [6] - Pantheris LV is expected to receive FDA clearance in mid-2023, with a limited launch planned shortly thereafter [38] Q&A Session Summary Question: Update on ISR data and its impact on product adoption - Management noted that the ISR data has been powerful in enabling the sales force to market the device effectively, leading to increased adoption [30] Question: Status of Tigereye ST limited launch - The limited launch has commenced, with initial results expected soon, and full commercial availability anticipated in Q3 2023 [34] Question: Expectations for Pantheris LV product launch - The company is hopeful for timely FDA clearance and plans to initiate a limited launch in Q3 2023, with full commercial availability expected in Q4 2023 [39]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class: Trading Symbol(s): Name of each exchange on which registered: Common Stock, par value $0.001 per share AVGR The Nasdaq Capital Market 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, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36817 ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $2 million, down from $2.3 million in Q3 and $2.4 million in Q4 2021, primarily due to reduced sales headcount [21] - Gross margin for Q4 was 34%, stable compared to 35% in Q3 and up from 30% in the year-ago quarter, reflecting a favorable product mix and cost efficiencies [21] - Net loss for Q4 2022 was $4.2 million, relatively stable compared to $4.1 million in Q3 and improved by 16% from $5 million in Q4 2021 [22] Business Line Data and Key Metrics Changes - Pantheris image-guided atherectomy products showed growth, with both Pantheris 7 French and Pantheris SV devices each growing 6% sequentially [8] - The Pantheris SV device is now the largest selling product, primarily used for treating below-the-knee lesions [9][10] Market Data and Key Metrics Changes - CMS increased outpatient reimbursement in hospitals by 4% to 5% while decreasing atherectomy reimbursement in Office Based Labs by approximately 6%, which is seen as a net positive for the company since 90% of revenue comes from hospital accounts [9] Company Strategy and Development Direction - The company launched the Lightbox 3 imaging platform, enhancing capabilities and efficiency in engaging with accounts [6] - Plans for 2023 include launching two new products: Tigereye ST for CTO crossing and Pantheris LV for atherectomy, which are expected to expand the addressable market [15][19] - The company is focused on increasing case coverage capability, driving new account activity, and completing regulatory approvals for new devices [19] Management's Comments on Operating Environment and Future Outlook - Management noted that while the direct impact of COVID has lessened, staffing shortages continue to affect procedure availability [8] - The company is optimistic about the potential of its proprietary OCT-guided approach to revolutionize the coronary market [7][16] Other Important Information - Cash and cash equivalents totaled $14.6 million as of December 31, indicating a strong financial position to fund strategic initiatives [22] - The company is conducting a post-market clinical study called Image BTK to evaluate Pantheris SV, with promising interim results [11][12] Q&A Session Summary Question: Confidence in approval of Tigereye ST and Pantheris LV - Management expressed confidence in nearing the end of the review process for Tigereye ST and anticipates clearance by mid-year for Pantheris LV, pending FDA review [25] Question: Commercialization strategy for new products - Both products will undergo a limited launch to gain clinical experience and support for physicians before a full commercial launch [27] Question: Learnings from Lightbox 3 usage - The new Lightbox 3 has accelerated new account acquisition and has been well-received by existing physicians due to its advanced imaging capabilities [29] Question: Timeline for starting clinical programs for coronary CTO product - The goal is to initiate clinical studies in 2024, following the completion of design selection and verification processes [31]

Financial Performance - The company generated revenues of $8.8 million in 2020, $10.1 million in 2021, and $8.3 million in 2022, with the decline in 2022 attributed to COVID-19 impacts and staffing shortages[308] - The company has an accumulated deficit of $402.4 million as of December 31, 2022, with net losses of $17.6 million and $17.4 million for the years ended December 31, 2022 and 2021, respectively[315] - Revenues decreased by $1.9 million, or 18%, to $8.3 million for the year ended December 31, 2022, primarily due to COVID-19 impacts and hospital staffing shortages[329] - Gross margin for the year ended December 31, 2022 decreased to 32% compared to 34% in the prior year, attributed to reduced production levels and economies of scale[331] - Research and development expenses decreased by $1.5 million, or 26%, to $4.4 million during the year ended December 31, 2022, mainly due to the completion of prior development efforts[332] - Selling, general and administrative expenses decreased by $1.4 million, or 9%, to $14.2 million for the year ended December 31, 2022, primarily due to decreased variable compensation and marketing costs[333] - The company reported net cash used in operating activities of $16.8 million for the year ended December 31, 2022, compared to $15.7 million in 2021[354] Regulatory Approvals and Product Development - The company received 510(k) clearance from the FDA for the Pantheris LV device in January 2023, targeting larger vessels such as the superficial femoral artery and popliteal arteries[300] - The company is developing CTO crossing devices for the coronary artery disease market, which is highly competitive and requires additional expenses for market understanding and product development[297] - The company is pursuing additional clinical data programs, including a post-market study, IMAGE-BTK, to evaluate the safety and efficacy of Pantheris SV in treating below-the-knee PAD lesions, with enrollment expected to complete in 2023[306] - The company received CE Marking for the original Ocelot product in September 2011 and has since expanded its product offerings with multiple 510(k) clearances for various devices[298] Market Conditions and Challenges - The company has experienced significant sales declines due to COVID-19, with fluctuating sales as hospitals deferred elective procedures, impacting future sales predictability[310] - The company anticipates ongoing impacts from COVID-19 and staffing challenges on product demand in the foreseeable future[330] - The company has faced supply chain disruptions and increased production costs due to inflationary pressures and COVID-19 impacts, which could affect its ability to meet customer demands[312] Financing and Cash Management - The company has financed operations primarily through equity and debt financing, with uncertainty regarding future cash generation to fund ongoing operations[337] - In January 2022, the company raised approximately $6.7 million from the sale of 7,600 shares of Series D Convertible Preferred Stock, which were converted into 950,000 shares of common stock by December 31, 2022[341] - The company sold 585,603 shares of common stock under the At The Market Offering Agreement in 2022, generating aggregate proceeds of $1.0 million at an average price of $1.67 per share[343] - The August 2022 Offering resulted in net proceeds of approximately $4.4 million from the issuance of 1,484,019 shares of common stock at a purchase price of $1.752 per share[344] - As of December 31, 2022, the company had a total CRG Loan obligation of $19.4 million, which includes future interest and a $2.2 million back-end fee due in December 2025[352] - Net cash provided by financing activities for 2022 was $11.9 million, primarily from the issuance of preferred stock and common stock[359] - The company plans to reactivate the At The Market Offering Agreement in March 2023, although there is no assurance of success in acquiring additional funding[343] Operational Obligations and Assets - The company’s operating lease obligations total approximately $5.8 million through November 2024, with a weighted average remaining lease term of 1.9 years as of December 31, 2022[353] - The company has contractual obligations totaling $22.8 million due by period, including operating lease obligations and non-cancelable purchase commitments[349] - The company maintains cash and cash equivalents with one financial institution, with deposits exceeding insured limits, indicating low credit risk[371] - The company evaluates inventories for excess quantities and obsolescence, adjusting carrying values to estimated net realizable value when necessary[368] Revenue Recognition - The company's revenues are derived from three main sources: sales of Lightbox consoles, disposables (catheters and accessories), and customer service contracts[362] - Revenue from Lightbox console sales is recognized upon delivery and acceptance, while disposable revenues are recognized when the product has shipped and collectability is assured[362][363] - Service revenue has been insignificant to date, with maintenance contract revenue recognized when work is completed[363] - As of December 31, 2022, there were no customers representing 10% or more of the company's accounts receivable, compared to one customer representing 21% in 2021[371] Interest and Financial Risk - Interest expense, net remained flat compared to the prior year, primarily due to higher loan balances from PIK interest being compounded[334] - Other income, net for the year ended December 31, 2022 decreased by approximately $2.3 million, or 100%, compared to the prior year due to the forgiveness of a PPP loan[335] - An immediate 100 basis point change in interest rates would not materially affect the fair value of the company's cash equivalents due to their short-term maturities[370] - The company does not currently use or plan to use financial derivatives in its investment portfolio[370] - The company’s business is primarily conducted in U.S. dollars, minimizing foreign currency risk[372]

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $2.3 million, an increase from $2.1 million in Q2 2022, driven by increased capital sales [36] - Gross margin for Q3 2022 was 35%, a 4 percentage point increase from 31% in Q2 2022, reflecting higher revenue levels and a shift in product mix [37] - Operating expenses for Q3 2022 were $4.5 million, slightly up from $4.4 million in Q2 2022, indicating tight control over expenses while advancing strategic initiatives [38] - Net loss for Q3 2022 was $4.1 million, an improvement from $4.2 million in Q2 2022 [38] - Adjusted EBITDA for Q3 2022 was a loss of $3.6 million, an improvement from a loss of $3.7 million in Q2 2022 [39] - Cash and cash equivalents totaled $17.3 million as of September 30, 2022, bolstered by $5 million raised in August [40] Business Line Data and Key Metrics Changes - Capital sales were a significant contributor to revenue growth in Q3 2022, supported by the launch of the Lightbox 3 imaging console [10] - The Pantheris SV small vessel atherectomy device showed strong market performance, particularly in treating below-the-knee lesions [11] Market Data and Key Metrics Changes - The company is making progress in the enrollment of the IMAGE-BTK post-market study, with expectations to enroll up to 60 patients [13] - Interim findings from the IMAGE-BTK study showed a 90% reduction in percent stenosis and zero complications within 30 days post-procedure [14] Company Strategy and Development Direction - The company is focused on expanding its technology platform and peripheral product portfolio, with plans for new product launches in 2023 [9][24] - The development of the first coronary product application aims to redefine the treatment of coronary artery disease, targeting a large addressable market [26][34] - Strategic areas for growth include increasing case volume, expanding the user base through the Lightbox 3 console, and advancing new peripheral devices through regulatory approval [33] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding progress in Q3 2022, while acknowledging potential challenges from hospital staffing and respiratory virus infections [36] - The company is excited about the upcoming launches of new devices and the potential to transform the treatment landscape for vascular diseases [35][41] Other Important Information - The company plans to prioritize R&D efforts on the coronary program in 2023, aiming for an investigational device exemption filing [32] Q&A Session Summary Question: Are there any questions from institutional investors? - There were no questions in the queue during the Q&A session [42]

Financial Performance - The company generated revenues of $10.1 million in 2021, an increase from $8.8 million in 2020, despite fluctuations due to COVID-19 impacts [121]. - The accumulated deficit as of September 30, 2022, was $398.2 million, with a net loss of $4.1 million for the three months ended September 30, 2022, and $13.4 million for the nine months ended [130]. - For the three months ended September 30, 2022, revenue decreased by approximately $0.1 million or 5% compared to the same period in 2021, reflecting fluctuating demand due to COVID-19 and hospital staffing shortages [144]. - For the nine months ended September 30, 2022, revenue decreased by $1.5 million or 19% compared to the same period in 2021, primarily due to the adverse impacts of COVID-19 and hospital capacity limitations [151]. - As of September 30, 2022, the company had cash and cash equivalents of $17.3 million and an accumulated deficit of $398.2 million, compared to $19.5 million and $384.8 million as of December 31, 2021 [157]. - The company expects to incur losses for the foreseeable future and believes its current cash and expected revenues will fund operations through Q3 2023 [157]. - Net cash used in operating activities for the nine months ended September 30, 2022 was $14.0 million, consisting primarily of a net loss of $13.4 million [174]. - The company raised approximately $6.7 million from the January 2022 Offering and $4.4 million from the August 2022 Offering, contributing to net cash provided by financing activities of $11.9 million for the nine months ended September 30, 2022 [178]. - The company sold 259,137 shares of common stock at an average price of $1.56 per share during the quarter ended September 30, 2022, generating aggregate proceeds of $0.4 million [164]. - Other income, net for the nine months ended September 30, 2022 decreased approximately $2.4 million or 101% compared to the same period in 2021, as the prior year included a one-time gain from the forgiveness of a PPP loan [156]. Research and Development - The company received 510(k) clearance from the FDA for the Pantheris device in October 2015, and for the next-generation version in May 2018, indicating ongoing product development and regulatory progress [113]. - The company is developing CTO crossing devices targeting the coronary artery disease market, which is highly competitive and requires significant investment [112]. - The Tigereye ST catheter, a next-generation CTO crossing system, was submitted for FDA clearance in July 2022, showcasing the company's commitment to innovation [114]. - The company completed patient enrollment for the INSIGHT clinical trial in July 2021, which supports the expansion of Pantheris for treating in-stent restenosis, potentially broadening its market [118]. - The company’s Lightbox 3 imaging console received FDA clearance in January 2022, reflecting advancements in its imaging technology [113]. Expenses and Cost Management - Gross margin for the three months ended September 30, 2022 increased to 35%, compared to 34% during the same period in 2021, driven by changes in product mix [146]. - Gross margin for the nine months ended September 30, 2022 decreased to 31%, compared to 35% in the same period in 2021, primarily due to decreased revenues and economies of scale [152]. - Research and development (R&D) expenses for the three months ended September 30, 2022 decreased by $0.3 million or 22% compared to the same period in 2021, mainly due to the completion of development efforts on the Lightbox 3 [145]. - R&D expenses for the nine months ended September 30, 2022 decreased by $1.3 million or 28% compared to the same period in 2021, attributed to the completion of previous development efforts [153]. - Selling, general and administrative (SG&A) expenses for the three months ended September 30, 2022 decreased by approximately $0.5 million or 13% compared to the same period in 2021, primarily due to decreased variable compensation [149]. - SG&A expenses for the nine months ended September 30, 2022 decreased by $0.9 million or 8% compared to the same period in 2021, mainly due to reduced variable compensation and selling costs [154]. - Interest expense, net for the three months ended September 30, 2022 decreased by less than $0.1 million or 3% compared to the same period in 2021, primarily due to increases in interest income [149]. Operational Challenges - The company has experienced supply chain disruptions and increased production costs due to inflation and COVID-19, which may impact future operations [126]. - The company suspended sales under the ATM Agreement on August 3, 2022, with no current commitments to obtain additional funds [164]. - The company has an operating lease obligation of $2.6 million due within one year and a total of $23.5 million in contractual obligations as of September 30, 2022 [171]. - The total CRG Loan amount is $13.7 million, with contractual obligations including future interest and a $2.2 million back-end fee due in December 2025 [171]. Financial Position and Risk - As of September 30, 2022, cash and cash equivalents were maintained with one financial institution in the U.S., with current deposits likely exceeding insured limits [181]. - Accounts receivable primarily relate to revenues from the sale of Lumivascular platform products, with one customer representing 11% of accounts receivable as of September 30, 2022, down from 21% at December 31, 2021 [181]. - The company believes the financial institution has sufficient assets and liquidity, posing little to no credit risk [181]. - The business is primarily conducted in U.S. dollars, with foreign currency transactions not expected to materially affect results [182]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair value of the company's cash equivalents [180].

Avinger, Inc. (NASDAQ:AVGR) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Matt Kreps – Investor Relations Jeff Soinski – Chief Executive Officer Nabeel Subainati – Principal Financial Officer Conference Call Participants Operator Good day, everyone, and welcome to today’s Avinger Second Quarter 2020 Results Call. [Operator Instructions] Please note, this call may be recorded. [Operator Instructions] It is now my pleasure to turn the program over to Matt Kreps, Investor Rel ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $1.9 million, reflecting a decrease due to hospital staffing challenges and access limitations [22] - Gross margin for Q1 2022 was 28%, with expectations for improvement as revenue grows [22] - Net loss for Q1 2022 was $5.1 million, flat compared to Q1 2021 [22] - Adjusted EBITDA for Q1 2022 was a loss of $4.6 million, compared to a loss of $4 million in Q1 2021 [23] - Cash and cash equivalents totaled $20 million as of March 31, 2022, following a fundraising of $7.6 million in January 2022 [23][24] Business Line Data and Key Metrics Changes - The launch of the Lightbox 3 imaging console has seen positive reviews and increased customer activity, contributing to improved procedural volume starting in March 2022 [6][8] - The company is developing two new catheter line extensions for its peripheral product portfolio, expected to broaden appeal and drive growth [10][12] Market Data and Key Metrics Changes - The company has identified a significant opportunity in the coronary artery disease market, with approximately 50,000 CTO PCI procedures performed annually in the U.S. [15][41] - The coronary market is seen as a transformational value opportunity due to its large addressable market and existing reimbursement profile [14][42] Company Strategy and Development Direction - Avinger aims to expand market penetration through the new Lightbox 3 and the development of innovative products for both peripheral and coronary applications [20][25] - The company is focused on leveraging its proprietary image-guided platform to address challenges in the coronary artery disease market [14][42] Management's Comments on Operating Environment and Future Outlook - Management noted a challenging hospital environment in Q1 2022 due to COVID-19 and staffing shortages, but expressed optimism about improving procedural volumes in Q2 2022 [6][30] - The company anticipates continued growth in procedural volumes and is encouraged by the recent commercial launch of the Lightbox 3 [20][30] Other Important Information - Mark Weinswig, the Chief Financial Officer, announced his resignation effective at the end of the week, initiating a search for a new CFO [20] - The company executed a reverse stock split in March 2022 to regain compliance with NASDAQ minimum bid rules [23] Q&A Session Summary Question: What caused the lower procedure volumes in the quarter? - Management indicated that both the Omicron variant surge and hospital staffing challenges contributed to the lower procedure volumes [28] Question: What is the current trend in procedure volumes? - Management reported a steady increase in procedural volume starting in March and continuing into May, with optimism for further growth [30] Question: How does the Lightbox 3 impact clinical staff utilization? - The portability of the Lightbox 3 has allowed for quicker engagement with new accounts and increased case volumes, demonstrating its effectiveness [32][34] Question: Were there any changes in the types of procedures performed? - Management noted a return to a more typical mix of procedures as elective procedures opened up, with an increase in SFA and popliteal cases [36] Question: What potential does the company see in the coronary artery disease market? - Management expressed excitement about the opportunity to make CTO PCI procedures more accessible and efficient, potentially reducing the need for invasive CABG procedures [41][42]