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NAVIDEA BIOPHARMACEUTICALS, INC. (NAVB)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 revenue was de minimis at $0.61K, with loss from operations narrowing to $(3.20)M and EPS at $(0.11); cash fell to $2.00M, highlighting urgent funding needs .
  • SG&A dropped sharply versus Q3 (Q4: $1.26M vs Q3: $3.64M), improving quarterly burn, while R&D remained elevated to support the RA pipeline (Q4: $1.89M) .
  • Management emphasized progressing RA Phase 3 (NAV3-33) and Phase 2B (NAV3-32), issued key patents, and reiterated a goal to secure full funding in 2023 and file INDs in 2024 .
  • Liquidity and NYSE compliance were central in Q&A; management expects financing to support regaining compliance by the cure deadline, a potential near-term stock catalyst if executed .

What Went Well and What Went Wrong

What Went Well

  • RA clinical execution advanced: active Phase 3 enrollment at 12 sites; preliminary Phase 2B data support distinguishing fibroid vs non-fibroid RA pathotypes and predicting anti‑TNF response. “Promising results… demonstrate the significant potential of our macrophage‑targeting Manocept platform.”
  • SG&A fell materially quarter-over-quarter ($1.26M in Q4 vs $3.64M in Q3), reflecting cost discipline after prior legal charge recognition in Q3 .
  • IP momentum: issued U.S. patent on macrophage phenotype alteration; additional patents in Israel and Canada; progress on a more stable linker to ease manufacturing scale‑up .

What Went Wrong

  • Revenues collapsed to $0.61K in Q4 (vs $7.52K in Q3 and $50.35K in Q4 2021), highlighting limited commercial contribution; gross loss persisted due to cost of revenue .
  • Cash declined to $2.00M with ongoing burn; investors pressed on runway and timing for capital infusion; management acknowledged resource constraints .
  • Legal overhang impacted SG&A earlier in 2022 (Q3 included $2.6M CRG judgment-related fees), and NYSE compliance remains a monitored risk pending financing .

Financial Results

Income Statement and EPS (USD)

MetricQ4 2021Q3 2022Q4 2022
Revenue ($USD)$50,348 $7,516 $610
Cost of Revenue ($USD)$0 $134,438 $50,036
Gross Profit (Loss) ($USD)$50,348 $(126,922) $(49,426)
Research & Development ($USD)$1,372,314 $1,186,419 $1,890,113
SG&A ($USD)$2,317,285 $3,637,450 $1,258,681
Loss from Operations ($USD)$(3,639,251) $(4,950,791) $(3,198,220)
Interest (Expense) Income, net ($USD)$(1,938) $(765,456) $(245,620)
Loss Before Taxes ($USD)$(3,652,163) $(5,707,825) $(3,482,628)
Net Loss Attrib. to Common ($USD)$(3,652,163) $(7,745,711) $(3,482,629)
EPS (Basic & Diluted)$(0.12) $(0.25) $(0.11)
Weighted Avg. Shares30,161,825 30,732,001 32,376,900

Balance Sheet and Liquidity (USD)

MetricDec 31 2021Sep 30 2022Dec 31 2022
Cash & Cash Equivalents$4,230,865 $4,600,791 $1,995,860
Total Assets$6,644,833 $6,258,432 $4,371,606
Total Liabilities$6,020,090 $10,925,548 $12,514,916
Stockholders’ Equity (Deficit)$624,743 $(4,959,633) $(8,143,310)

Trailing Trend Including Q2 2022 (USD)

MetricQ2 2022Q3 2022Q4 2022
Revenue$57,000 (net) $7,516 $610
R&D$1,745,000 $1,186,419 $1,890,113
SG&A$1,300,000 $3,637,450 $1,258,681
EPS (Basic & Diluted)$(0.10) $(0.25) $(0.11)
Cash & Cash Equivalents (period end)$328,000 $4,600,791 $1,995,860

Segment / Revenue Breakdown

ItemQ4 2022
Revenue sources commentaryDecrease driven by absence of prior-year debt recovery, Cardinal R&D reimbursements, lower NIH grant revenue, and reduced EU transitional license revenue

KPIs (Clinical and Corporate)

KPIQ2/Q3 ContextQ4 2022 Update
NAV3-33 Phase 3 participants30 enrolled as of early Sept 2022; strong per-site enrollment; target sample depends on responder/non-responder mix 50th participant announced Nov 2022; active enrollment at 12 sites
NAV3-32 Phase 2B biopsy-imagingPreliminary 11–13 patient data differentiated fibroid vs non-fibroid pathotypes; ongoing enrollment to fill all buckets Positive preliminary results presented at ACR; continued recruitment
Patents / IPIssuances incl. leishmaniasis treatment constructs; multiple new provisionals U.S. patent on macrophage phenotype; additional patents in Israel/Canada; linker chemistry provisional
Manufacturing readinessAdvancing new API and final drug product suppliers Progress toward clinical/commercial supply for RA and Lymphoseek
Liquidity / runwayEstimated runway into Q1 2023 post-rights offering Cash $2.0M; burn concerns (investor Q&A)
NYSE complianceCure period until July 28, 2023 Expectation to regain compliance contingent on financing

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RA Phase 3 (NAV3-33) funding2023Board actively pursuing capital; plan to fully fund Phase 3 “Goal is to be fully funded this year” reiterated Maintained
RA Phase 3 completion/NDA2023–2024Complete Phase 3 then NDA; timing depends on enrollment/responders Continue to enroll; proceed to NDA post follow-up and data write-up Maintained
Therapeutic INDs (oncology/anti‑inflammatory)2024Target IND filings in 2024 “Still our goal and objective” for 2024, subject to funding Maintained
Financial guidance (revenue/margins)N/ANone providedNone providedNo formal guidance
NYSE complianceBy Jul 28, 2023Cure plan accepted; updates quarterly Expect to regain compliance with upcoming financing Reaffirmed pathway

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2022)Trend
RA clinical executionOpened 9 additional sites (12 total); 30 enrolled; strong preliminary Phase 2B data; detailed trial size drivers Active enrollment at 12 sites; preliminary NAV3‑32 data reinforced; automation with MIM Software advancing Improving execution
Funding/liquidityRights offering $6.2M gross; $800K reimbursement; runway into Q1’23; pursuing $35M raise Board working on capital infusion “soon”; acknowledged resource limits and burn Near‑term critical
NYSE complianceCure period to 7/28/23; plan accepted Expect to regain compliance with financing Conditional progress
Lymphoseek ex‑USSeeking partner; earlier EU challenges (pricing vs Nanocoll) Transparent discussion: EU competition and pricing; pursuing partners; manufacturing readiness Cautious engagement
Manufacturing/supplyAdvancing new API/product suppliers Advancing toward clinical/commercial supply; enables China/India partners Progressing
IP/patentsLeishmaniasis patent; multiple provisionals U.S. patent on macrophage phenotype; Israel/Canada patents; new stable linker Strengthening moat
Therapeutics pipelinePreclinical efficacy (tumor growth reduction; bisphosphonates, paclitaxel); M1/M2 macrophage focus Aim for INDs in 2024; 76% avg tumor growth reduction in mouse models; phenotype reprogramming discussed Advancing toward IND
PartnershipsPost‑Jubilant, broader partner options (nuclear pharmacies, large pharma) Active discussions on biomarker partnerships; stronger negotiating position post-trials Building optionality
Macro/tariffs/supply chainCOVID and site reopening affected timelines Not a major focus; ongoing site management Neutral

Management Commentary

  • “We will continue RA Phase III trial success to full enrollment, NDA submission and FDA approval… Our goal is to be fully funded this year.” – Michael Rosol .
  • “Preliminary results… support our hypothesis that we can distinguish between fibroid and non-fibroid pathotypes of RA with a single scan.” – Michael Rosol .
  • “We are optimistic that we’ll have something to announce around capital infusion soon… the Board… is working diligently.” – Michael Rosol .
  • “U.S. patent… covers the ability… to stimulate an immune response against tumors through targeted delivery… change the nature of macrophages to make them more proinflammatory.” – Michael Rosol .
  • “Expectation… we will indeed… regain compliance with NYSE by the end of the cure period.” – Erika Eves .

Q&A Highlights

  • Liquidity runway and burn: Investors questioned operations timeline with ~$2.0M cash and ~$0.8–1.0M/month burn; management signaled near‑term financing updates .
  • NYSE compliance: Management expects financing to support regaining compliance by July 28 cure date .
  • Lymphoseek EU strategy: Detailed competitive landscape (Nanocoll), pricing missteps, renewed partner efforts, and manufacturing readiness for ex‑US supply .
  • RA revenue model timing: Potential revenue remains “robust,” but timing could slip given site openings and resource constraints; trajectory still intact .
  • Partnerships: Continuing discussions to use tilmanocept as a biomarker in pharma RA pipelines; strongest deal terms likely post-trial completion/NDA .
  • Therapeutic IND timing: 2024 remains achievable subject to funding and preclinical safety/manufacturing scale‑up .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2022 EPS and revenue was unavailable for NAVB. We attempted retrieval, but consensus could not be fetched due to missing mapping; therefore, no vs‑consensus comparisons are provided.

Key Takeaways for Investors

  • Liquidity is the near‑term gating factor; a credible capital infusion would likely catalyze shares and de‑risk clinical timelines and NYSE compliance .
  • Operational discipline improved: SG&A fell from $3.64M (Q3) to $1.26M (Q4), narrowing operating loss despite minimal revenue; watch if this cost profile is sustainable as trials scale .
  • Clinical catalysts: Continued Phase 3 enrollment and full readouts from NAV3‑32 can enhance partnering leverage and validate the RA biomarker thesis .
  • IP strengthens strategic positioning: patents on macrophage phenotype modulation and manufacturing chemistry support defensibility in both diagnostics and therapeutics .
  • Commercial optionality: Multiple partner pathways (nuclear pharmacies, pharma in RA) exist; best economics likely post‑trial completion/NDA submission .
  • Execution risk remains: Very low revenue base and negative equity underscore sensitivity to financing and clinical timelines; monitor cash updates and trial enrollment pace .
  • Discrepancies to note: Management’s call commentary contained a Q4 R&D figure (~$1.0M) inconsistent with 8‑K tables ($1.89M); anchor analyses to filed financials .

Notes on Discrepancies and Non‑GAAP

  • Q4 revenue was cited as “approximately $1,000” in narrative; the filed statement shows $610; we use $610 as the definitive figure .
  • The call cited Q4 R&D of ~$1.0M vs $1.89M in the 8‑K; our tables rely on the 8‑K figures .