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Baudax Bio, Inc. (BXRX)·Q3 2022 Earnings Summary

Executive Summary

  • Q3 2022 net product revenue was $0.238M, down ~15% YoY despite a 16% YoY increase in ANJESO vials sold to end-users; revenue pressure was driven by higher 340B mix and associated discounts .
  • Material non-cash impairments drove a widened GAAP net loss: $17.746M intangible impairment and $3.662M property impairment; GAAP net loss was $29.205M ($2.47 loss per share) vs. $16.962M ($7.03 loss per share) in Q3 2021, while adjusted net loss improved to $4.619M from $11.312M .
  • Liquidity remains constrained: cash and equivalents were $5.647M; the company obtained credit agreement waivers and reduced minimum liquidity covenants in late October but disclosed substantial doubt about going-concern absent additional capital .
  • NMB pipeline advanced: BX1000 Phase II trial underway with interim analyses planned early-1H23; BX2000 dose escalation cohorts progressing with completion targeted mid-2023; BX3000 reversal agent IND-supporting studies expected to complete 1H23; USPTO issued a Notice of Allowance for an Orange Book-listable ANJESO patent .
  • No formal financial guidance issued; near-term stock narrative centers on impairment reset, revenue mix headwinds, covenant risk, and pipeline execution milestones .

What Went Well and What Went Wrong

What Went Well

  • “Our NMB agents remain on track… Phase II trial for BX 1000 is underway… BX 2000 is continuing to enroll additional cohorts… We believe that the data from these trials will provide us with insight on which blocking agent to preferentially move forward later in 2023.” – Gerri Henwood, President & CEO .
  • ANJESO patent progress: USPTO Notice of Allowance for methods of administering IV meloxicam and filing to add to FDA Orange Book, strengthening IP and potentially clinical adoption messaging .
  • End-user demand indicators: ANJESO vials sold up ~16% YoY in Q3; Q2 showed strong volume KPIs (67% YoY vials growth, 12% sequential hospital vials increase, 72% reorder rate), suggesting usage deepening even with a reduced field force .

What Went Wrong

  • Revenue mix headwinds: net product revenue fell ~15% YoY due to higher 340B volumes and associated discounts, despite end-user vial growth .
  • Major impairments: reduced ANJESO intangible to $2.0M and wrote down construction-in-progress for a second manufacturing suite; GAAP net loss widened to $29.2M on these non-cash charges .
  • Liquidity and covenant risk: minimum liquidity covenant waivers and reductions indicate tight cash; the company disclosed substantial doubt regarding going concern absent fresh financing; dedicated commercial team eliminated in September, raising commercialization capacity concerns .

Financial Results

Income Statement – Sequential Comparison (oldest → newest)

Metric ($USD Millions)Q1 2022Q2 2022Q3 2022
Revenue, net$0.422 $0.300 $0.238
Cost of sales$0.648 $0.361 $1.208
Research & development$1.293 $0.912 $0.645
Selling, general & administrative$14.190 $4.029 $3.808
Operating loss$(12.545) $(6.972) $(28.696)
Net loss$(12.809) $(7.531) $(29.205)
Net loss per share (basic & diluted)$(3.17) $(1.05) $(2.47)

Year-over-Year Comparison (oldest → newest)

Metric ($USD Millions)Q3 2021Q3 2022
Revenue, net$0.281 $0.238
Cost of sales$0.462 $1.208
Research & development$0.658 $0.645
SG&A$11.074 $3.808
Net loss$(16.962) $(29.205)
Net loss per share$(7.03) $(2.47)

Non-GAAP Adjusted Net Loss (oldest → newest)

Metric ($USD Millions)Q2 2022Q3 2022
Adjusted net loss$(4.950) $(4.619)

Liquidity Metrics (oldest → newest)

Metric ($USD Millions)Q1 2022Q2 2022Q3 2022
Cash & cash equivalents$11.527 $5.210 $5.647

KPIs – ANJESO Commercial Indicators (oldest → newest)

KPIQ1 2022Q2 2022Q3 2022
Vials sold to end-users YoY change+141% +67% +16%
Hospital vials vs prior quarterNA+12% NA
Reorder rate from existing accountsNA72% NA
Net product revenue$0.422M $0.300M $0.238M

Segment Breakdown

Company SegmentNotes
Single segmentThe company operates in one segment focused on innovative products for hospital and related settings .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BX1000 – Phase IIEarly 2023 interim analysesExpected to begin Phase II in 2022 Phase II underway; interim dose analyses planned early 2023; additional interim analyses in 1H23 Progressed (milestone achieved)
BX2000 – Phase I dose escalationCompletion timingComplete enrollment by early 2023 Complete remaining cohorts by mid-2023 Delayed (timing pushed out)
BX3000 – Reversal agent (IND support)1H 2023IND-supporting data submission by early 2023; Phase I targeted 1H23 Complete nonclinical and manufacturing studies to support IND in 1H23 Maintained
Financial guidance2022None disclosedNone disclosedMaintained (no formal ranges)
Liquidity covenant4Q22–1Q23Minimum liquidity $5.0M Temporarily reduced to $3.0M (Oct–Nov), $4.5M (Dec–Feb), then $4.0M (Mar+) Amended downward (temporary relief)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
NMB pipeline executionBX2000 Phase I first cohort dosed; BX1000 Phase II to begin in 2022 BX1000 Phase II underway; BX2000 cohorts enrolling; BX3000 IND-supporting studies tracking to 1H23 Positive execution; minor timeline slippage on BX2000
ANJESO commercializationBest quarter since launch in Q1; strong QoQ and YoY vial growth Vials sold up 16% YoY, but revenue down ~15% YoY on 340B mix/discounts Mixed: demand growth vs revenue/mix headwinds
COVID-19 impactsStaffing shortages and elective surgery reductions affecting demand/access Omicron variants and staffing issues continue to impact elective surgeries; stabilizing but still variable Ongoing headwind, gradually stabilizing
Financing & liquidityGoing-concern risk; capital raises in March and May 2022 September $6.2M offering closed; covenant waivers/reductions; substantial doubt persists Tight liquidity; reliance on external capital
Legal/regulatorySecurities litigation settlement preliminarily approved (May 2022) Final approval hearing held Oct 26, 2022 (decision pending at filing) Nearing resolution
Intellectual property—USPTO Notice of Allowance; Orange Book filing for ANJESO method patent Strengthening IP position

Management Commentary

  • “We believe that the data from these trials will provide us with insight on which blocking agent to preferentially move forward later in 2023… We expect that planned interim analyses will provide insight regarding doses to progress for BX 1000 by early 2023.” – Gerri Henwood, President & CEO .
  • “We are also pleased to see ANJESO sales performance reflect a modest increase of 16% in vials sold to end users… however increased volume to 340B hospitals and the impact of associated discounts caused revenue for the third quarter of 2022 to be lower than the same prior year quarter.” – Gerri Henwood .
  • “USPTO… Notice of Allowance… filed with the FDA to be added to the Orange Book patent list.” – Gerri Henwood .

Q&A Highlights

  • No Q3 2022 earnings call transcript was available in our document set; therefore Q&A highlights and any guidance clarifications from a call could not be synthesized [functions.SearchDocuments returned none for BXRX; ReadDocument on transcript failed].

Estimates Context

  • S&P Global consensus EPS and revenue estimates for BXRX Q3 2022 were unavailable via the tool due to missing mapping; as a result, we cannot quantify beats/misses vs Wall Street consensus at this time. Values retrieved from S&P Global were unavailable.
Consensus (Q3 2022)Value
Revenue Consensus MeanNA*
Primary EPS Consensus MeanNA*
Primary EPS – # of EstimatesNA*
Revenue – # of EstimatesNA*

*Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • ANJESO demand indicators improved (vial growth), but revenue is pressured by a higher 340B mix and discounts; focus on mix management and access strategies could improve net sales yield .
  • Impairment reset materially reduces ANJESO intangible carrying value, aligning the balance sheet with current expectations and lowering future amortization; however, it underscores commercialization challenges and contributes to GAAP losses .
  • Liquidity is tight and covenant risk persists despite temporary waivers; near-term catalysts include securing non-dilutive licensing or financing, and disciplined cash management to maintain reduced liquidity thresholds .
  • Pipeline execution is the core medium-term thesis: BX1000 Phase II data readouts and BX2000 Phase I completion (mid-2023) could be decision points for prioritization; BX3000 IND-enabling completion in 1H23 sets up the reversal agent program .
  • IP strengthening (Orange Book-listable patent allowance) adds durability to ANJESO, potentially supporting formulary adoption and pricing conversations over time .
  • COVID-19-related elective surgery and staffing headwinds remain a variable overhang; stabilization could help volume, but pricing/mix dynamics are key to converting usage into revenue .
  • With no formal financial guidance and no available consensus estimates, trading may be headline-driven around financing events, covenant disclosures, and pipeline milestones; risk management should weigh dilution scenarios against pipeline optionality .