Executive Summary

Q3 2024 revenue was $1.65M with gross margin improving to 26% (from 20% in Q2), while operating expenses fell to $4.10M; net loss improved to $3.71M and adjusted EBITDA loss to $3.37M .
Cost-reduction program (headcount -24%) and a leaner commercial footprint preserved ~90% of revenue versus Q2 and prior year and improved productivity; sales team now 16 professionals focused on high-value sites .
The company initiated full commercial launch of Pantheris LV late in Q3; LV revenue increased >20% vs Q2, suggesting positive early adoption .
Coronary CTO program advanced: IDE pre-submission filed in September; IDE application shifted from Q3 (prior guide) to Q4 2024, with clinical enrollment anticipated in H1 2025; China registration for peripheral products targeted in 2025 via Zylox-Tonbridge partnership .

What Went Well and What Went Wrong

What Went Well

Gross margin expanded to 26% (from 20% in Q2 and 21% YoY), reflecting improved operating efficiency post realignment; operating expenses declined sequentially to $4.1M .
Early commercial traction for Pantheris LV: “our Pantheris LV revenue did increase over 20% versus the sales in the second quarter” .
Coronary CTO program hit key milestones: completion of Phase III V&V testing and FDA pre-submission, planning multi-site enrollment and targeting H1 2025 start; management emphasized favorable reimbursement dynamics in coronary CTO and OCT imaging .

What Went Wrong

Revenue dipped sequentially and YoY to $1.65M (vs $1.85M in Q2 and $1.82M in Q3 2023), consistent with reduced field footprint; net loss remains sizable despite improvement .
SG&A decreased ~$0.6M (-16%) QoQ, but R&D rose ~$0.2M (+20%) QoQ as resources shifted to coronary development, sustaining cash burn albeit strategically .
Consensus estimates not available via S&P Global (coverage/mapping gap), limiting external benchmark comparisons for revenue/EPS; investors must rely on internal trajectory and execution milestones (see Estimates Context).

Financial Results

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD Millions)	$1.817	$1.847	$1.650
Gross Margin (%)	21%	20%	26%
Gross Profit ($USD Millions)	$0.388	$0.378	$0.426
Total Operating Expenses ($USD Millions)	$4.421	$4.505	$4.095
Operating Income (Loss) ($USD Millions)	$(4.033)	$(4.127)	$(3.669)
Net Loss ($USD Millions)	$(4.476)	$(4.362)	$(3.706)
Diluted EPS ($USD)	$(2.92)	$(2.82)	$(1.82)
Adjusted EBITDA ($USD Millions)	$(3.740)	$(3.834)	$(3.371)

Notes: Adjusted EBITDA defined and reconciled in press release exhibits .

Segment breakdown: Not disclosed; Avinger does not report operating segments in the materials reviewed .

KPIs (current quarter)

KPI	Q3 2024
Sales team size (professionals)	16
Headcount reduction (%)	24%
Pantheris LV revenue change QoQ (%)	>20% increase vs Q2
Cash and cash equivalents ($USD Millions)	$5.901

Guidance Changes

Metric/Item	Period	Previous Guidance	Current Guidance	Change
Coronary CTO IDE application timing	Q3–Q4 2024	IDE filing by end of Q3 2024	IDE application anticipated in Q4 2024, pending completion of pre-submission process	Delayed by ~1 quarter
Coronary clinical enrollment start	H1 2025	Clinic start early 2025 post IDE clearance (4–6 months typical)	Enrollment anticipated upon IDE approval in H1 2025	Maintained
China NMPA registration clearance (peripheral products, Lightbox 3)	2025	Registration could be achieved prior to end of 2025	Registration clearance anticipated in 2025	Maintained
Zylox manufacturing scale-up for Avinger products	Mid-2025	Not specified previously	Full manufacturing scale-up anticipated by mid-2025	New/Initiated
Pantheris LV launch status	Q3 2024	Building inventory for full commercial launch in coming weeks	Full commercial launch initiated; >20% LV revenue growth vs Q2	Completed/Executed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1, Q2)	Current Period (Q3 2024)	Trend
Coronary CTO device development	Q1: Advanced to Phase III, IDE filing targeted Q3 2024 . Q2: Phase III V&V on track; highlighted reimbursement and clinical efficiency .	Filed FDA pre-submission in Sept; IDE application anticipated Q4; plan 110-patient study, H1 2025 enrollment; 5 sites identified, aiming 10+ .	Continued progress; timing shifted by one quarter; expanded site planning
Cost structure and focus	Q1: Higher opex from sales headcount and Zylox transaction . Q2: Implemented -24% headcount to streamline peripheral ops .	First full quarter reflecting savings: opex down, gross margin up; sales team 16 pros; revenue per sales head improved .	Efficiency realized; margins improving
Peripheral products (Pantheris LV, Tigereye ST)	Q1: Tigereye ST full launch; LV limited launch . Q2: LV inventory build for full launch .	LV full commercial launch; >20% LV revenue growth vs Q2; positive physician feedback on simplicity .	Commercial expansion; positive early adoption
China strategy (Zylox-Tonbridge)	Q1: Partnership announced; 2025 launch targeted; potential manufacturing, royalty structure . Q2: Type testing and filing prep underway .	Innovative device review designation for Pantheris; filings targeted by year-end; 2025 clearance; manufacturing scale-up mid-2025 .	Regulatory momentum; manufacturing capability building
Reimbursement dynamics	Q2: Coronary CTO and OCT imaging codes post-clearance .	Coronary device expected to access high-value reimbursement codes immediately upon clearance .	Reinforced positive economics

Management Commentary

“In the third quarter, we began to see the impact of recent initiatives to streamline costs, enhance operational efficiency…Operating expenses have decreased significantly…while revenue has remained in line despite a leaner commercial team, and gross margins have improved for the second consecutive quarter” .
“We filed a pre-submission package with the FDA…Once the presubmission process is complete…we’ll be ready to file the IDE…targeting 110 patients with a 30-day follow-up” .
“Our Pantheris LV…is designed to streamline the atherectomy procedure and paired with our portable Lightbox 3…expand the mainstream appeal of our image-guided platform” .
“Zylox recently received the prestigious Innovative Medical Device review designation for our Pantheris device in China…enables priority regulatory review” .

Q&A Highlights

Pantheris LV adoption: Physicians value simplicity and streamlined procedure; LV revenue grew >20% QoQ despite late-quarter full launch .
China regulatory and manufacturing: All products passed type testing; filings expected by year-end; regulatory approval projected 2H 2025; Zylox building manufacturing lines with Avinger support; scale-up mid-2025 .
Strategic rationale for cost reductions: -24% headcount primarily in sales/marketing to focus investment on coronary program; expect some peripheral revenue softening offset by efficiency and future Zylox upside .

Estimates Context

Wall Street consensus for Q3 2024 Revenue and EPS was unavailable via S&P Global due to missing CIQ mapping for AVGR; as a result, external benchmark comparisons could not be performed.
Implication: Internal trajectory (gross margin expansion, opex reduction, LV launch) and milestone execution (IDE timing, China filings) become the primary anchors for investor assessment .

Metric	Actual Q3 2024
Revenue ($USD Millions)	$1.650
EPS (Diluted, $USD)	$(1.82)

Note: Consensus estimates were unavailable via S&P Global for AVGR this quarter.

Key Takeaways for Investors

Efficiency inflection: Gross margin improved to 26% and opex declined to $4.1M, driving sequential improvement in net loss and adjusted EBITDA; continued execution here is key to cash runway extension .
Coronary CTO catalyst: IDE application now targeted for Q4 2024; H1 2025 enrollment; favorable reimbursement expected in coronary CTO and OCT imaging could accelerate adoption post clearance .
Pantheris LV launch traction: >20% QoQ LV revenue growth suggests product-market fit; watch adoption pace into Q4/Q1 and contribution to gross margin mix .
China optionality: Innovative device designation and 2025 registration target, plus mid-2025 manufacturing scale-up, create royalty and potential COGS benefits over time .
Liquidity: Cash was $5.9M at 9/30; balance sheet improved earlier in 2024 via debt conversion and financing—monitor burn rate versus milestones .
Near-term trading lens: Stock likely sensitive to IDE filing timing (Q4) and any early LV adoption updates; a delay would be a negative catalyst, while on-time IDE and LV momentum are positives .
Medium-term thesis: Value hinges on coronary program de-risking (clinical outcomes, reimbursement capture) and China commercialization; execution on manufacturing transfer could structurally improve margins .

Avinger Inc (AVGR)·Q3 2024 Earnings Summary