Executive Summary

Q1 2022 revenue was $0.27M (+164% YoY) with gross margin 39.0%; net loss was $(1.13)M or $(0.04)/sh. Management cited component sourcing delays that pushed roughly $0.3M of shipments into Q2, creating a significant backlog and timing-driven sequential softness .
Commercial progress continued: broader VA footprint, NICE recommendation for UroShield, Health Canada licensing (PainGuard/UroGuard), and a 510(k) submission for PainShield MD PLUS. Management expects supply chain challenges to abate in 2H22 and reiterated cash of ~$6.0M and zero debt at 3/31/22 .
Trend vs prior quarters: Q4’21 revenue is derivable at ~$0.78M (FY’21 $1.70M minus first 9M’21 $0.92M), implying Q1 sequential decline driven by shipment timing and supply components; gross margin similarly dipped vs Q4 (see table) .
Key near-term stock catalysts: Q2 revenue catch-up from the ~$0.3M Q1 delay, regulatory updates (PainShield Plus/RELIEF), and UK/NHS traction following NICE guidance; a noted overhang is the FY21 arbitration accrual ($1.5M) tied to a former distributor .

What Went Well and What Went Wrong

What Went Well
- “First quarter sales were up significantly year-over-year despite component sourcing challenges… We expect that the delay will only impact the timing of revenue recognition as demand for our products remains robust.” – CEO Brian Murphy .
- Distribution and regulatory momentum: NICE recommendation for UroShield, Health Canada licensing (PainGuard/UroGuard), and expanded VA presence; also submitted a 510(k) for PainShield MD PLUS .
- Liquidity and balance sheet: “$6.0 million in cash on hand and zero debt at the end of the first quarter of 2022” supporting commercialization initiatives .
What Went Wrong
- Margin compression: Q1’22 gross margin fell to 39.0% from 74.8% YoY, as mix and manufacturing costs weighed on profitability despite revenue growth .
- Supply chain restraints impacted revenue timing: ~$(0.3)M of orders slipped from Q1 into Q2 (backlog) .
- Structural profitability still a challenge: total operating expenses were $1.22M vs revenue of $0.27M (net loss $(1.13)M); FY21 also included a $1.5M arbitration accrual impacting G&A and highlighting legal/reimbursement execution risks .

Financial Results

Metric	Q2 2021	Q3 2021	Q4 2021 (Derived)	Q1 2022
Revenue ($USD Millions)	$0.318	$0.499	$0.775 (FY’21 $1.695 − 9M’21 $0.920)	$0.272
Gross Profit ($USD Millions)	$0.208	$0.228	$0.228 (FY’21 $0.770 − 9M’21 $0.542)	$0.106
Gross Margin %	65%	46%	29.4% (0.228 / 0.775)	39.0%
Total Operating Expenses ($USD Millions)	$1.199	$1.096	$2.940 (FY’21 $6.453 − Q1–Q3’21 $3.513)	$1.218
Net Income (Loss) ($USD Millions)	$(0.216)	$(6.675)	$(2.474) (FY’21 $(14.282) − Q1–Q3’21 $(11.808))	$(1.132)
Diluted EPS ($)	$(0.01)	$(0.26)	N/A	$(0.04)

Notes:

Q4 2021 figures are derived from filed annual and year-to-date numbers; see citations per cell.
9M’21 revenue ($0.920M) and gross profit ($0.542M) are from Q3’21 10-Q; FY’21 totals are from the 10-K .
Q1’22 detailed P&L figures from the 8‑K exhibit tables .

KPIs and Balance Sheet (selected):

Backlog/Timing: ~$0.3M of Q1 orders delayed into Q2; “significant backlog” exiting Q1 .
Cash & Equivalents and Debt (as of 3/31/22): ~$6.0M cash; zero long-term debt .
Working capital snapshot (3/31/22): Cash $5.99M, total current assets $7.39M, total current liabilities $2.01M .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue (timing comment)	Q2 2022	None	~$0.3M of Q1 shipments expected to be recognized in Q2 (timing)	— (timing)
Supply Chain	2H 2022	None	Challenges “expected to abate” moving into 2H22	Positive tone
Regulatory	2022	None	510(k) submitted for PainShield MD PLUS; NICE recommendation; Health Canada licensing (PainGuard/UroGuard)	Positive updates

No numerical revenue, EPS, or margin guidance was provided in Q1’22 materials .

Earnings Call Themes & Trends

(There was no Q1’22 earnings call transcript available; themes below reflect recent disclosures.)

Topic	Previous Mentions (Q2 2021)	Previous Mentions (Q3 2021)	Current Period (Q1 2022)	Trend
Supply chain/manufacturing	Demand exceeded supply; searching for additional manufacturers (US/MX/UK/IL)	Noted no current production delays; continued COVID risks	Component sourcing delayed ~$0.3M shipments; expect abatement in 2H22	Improving by 2H22
Distribution/VA	VA channel momentum; UPPI contract expanded	Distributors drove 95%+ of sales YTD	VA footprint broadened; new workers’ comp provider agreement (EZ Health Care)	Expanding
Reimbursement	CMS code pursuit; DME supplier status	CMS K1004 in place for PainShield; ongoing efforts	Continued enhancement of reimbursement channels	Gradual progress
Regulatory	OTC PainShield RELIEF planned; UroShield TGA AU approval	FDA Enforcement Discretion for UroShield; UK study progress	510(k) filed (PainShield MD PLUS); NICE guidance; Health Canada licenses	Positive
Product performance	UPPI-driven sales; OTC PainShield RELIEF launch plans	Q3’21 revenue $0.499M; heavier OpEx and non-cash swings	Q1’22 +164% YoY revenue; margin compression; backlog for Q2	Mixed (volume up, margin down)
Legal/Regulatory risk	—	Nasdaq listing remediation; derivative liability changes	FY21 arbitration award accrued ($1.5M)	Risk overhang

Management Commentary

“We continued our efforts to expand distribution of our products through new partnerships in the workers’ compensation market and by securing regulatory approvals both domestically and in the U.K. and Canada.” – Brian Murphy, CEO .
“First quarter sales were up significantly year-over-year despite component sourcing challenges that caused a delay in first quarter order shipments of approximately $300,000… We believe our manufacturing is stable, and we do not expect our supply chain to be an issue for the remainder of the year.” – Brian Murphy .
“Our balance sheet remains strong with $6.0 million in cash on hand and zero debt at the end of the first quarter of 2022.” – Brian Murphy .

Q&A Highlights

No Q1 2022 earnings call transcript or Q&A was located in company documents for the period reviewed [ListDocuments (no transcripts found 2022)].

Estimates Context

Wall Street consensus (revenue/EPS) for Q1 2022 was not available via S&P Global in our pull (request limit exceeded), and NAOV appears to have limited analyst coverage. As a result, we cannot provide a verified consensus comparison for Q1 2022 results at this time. We attempted to source “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for Q1 2022 from S&P Global but were unable to retrieve them due to system constraints [functions.GetEstimates error].

Key Takeaways for Investors

Timing-driven Q1 softness with a visible Q2 catch-up: ~$0.3M of delayed shipments and a “significant backlog” position Q2 for sequential improvement, contingent on supply chain normalization .
Commercial/regulatory momentum is building (NICE, Health Canada, 510(k) for PainShield MD PLUS, VA and workers’ comp channels), which can broaden addressable markets and support revenue durability through 2H22 .
Margin trajectory is the swing factor: sustained mix shifts and cost normalization are needed to recover from the 39% GM in Q1 and low-30s implied in Q4’21; watch pricing, product mix (VA, distributors) and manufacturing costs .
Liquidity is adequate near term (cash ~~$6.0M; no debt), but scale is required to offset OpEx (~~$1.2M/Q in Q1). Monitor cash burn versus commercialization milestones .
Legal overhang from the Protrade arbitration (accrued $1.5M in FY21) bears watching for any cash settlement or operational distraction .
Catalysts: Q2 revenue inflection (shipment timing), FDA updates (PainShield Plus/RELIEF), NHS/NICE adoption proof points, and further VA/workers’ comp uptake .

Citations

Q1 2022 8‑K/press release and exhibit tables:
Q2 2021 8‑K:
Q3 2021 10‑Q:
FY 2021 10‑K:

NanoVibronix, Inc. (NAOV)·Q1 2022 Earnings Summary