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Baudax Bio, Inc. (BXRX)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 was a transition quarter: BXRX discontinued ANJESO commercialization and refocused on its neuromuscular blocking (NMB) portfolio; BX1000 Phase II enrollment expected to complete in Q1 2023 with top-line data early Q2 2023, and BX2000 dose escalation continuing through 2023 .
  • Revenue was $0.31M; GAAP net loss was $9.25M (including significant non-cash charges), while non-GAAP adjusted net loss improved to $3.19M versus $11.87M in Q4 2021 .
  • Cost of sales surged to $4.79M driven by a $4.44M inventory reserve write-off; ANJESO intangible was impaired by $1.94M, and construction-in-progress was reduced by $0.50M, reflecting the strategic exit from ANJESO commercialization .
  • Cash and equivalents ended at $5.26M; the company closed a $5.0M public offering in December and saw ~$4.3M of warrant exercises in January 2023, supporting near-term development activities .
  • Key near-term stock catalysts: BX1000 Phase II top-line data expected early Q2 2023; BX3000 IND target in summer 2023; clarity on prioritization between BX1000/BX2000 in 2023 .

What Went Well and What Went Wrong

  • What Went Well

    • “Encouraging interim data” for BX1000: all 20 subjects met Good/Excellent intubating conditions at 60 seconds; no severe/serious adverse events, supporting the NMB strategy’s clinical promise .
    • Strategic refocus on NMB portfolio with clear timelines: BX1000 Phase II enrollment completion targeted Q1 2023; top-line data early Q2 2023; BX2000 dose escalation progressing; BX3000 IND in summer 2023 .
    • Non-GAAP loss improved year-over-year: Q4 2022 adjusted net loss of $3.19M vs $11.87M in Q4 2021, reflecting lower SG&A and shift away from commercial spend .

  • What Went Wrong

    • ANJESO commercialization discontinued due to hospital economic challenges, eliminating future product revenue near-term and necessitating related impairments .
    • Cost of sales spiked to $4.79M on a $4.44M inventory reserve write-off; GAAP net loss was $9.25M with $6.1M non-cash charges in Q4 2022 .
    • Development timing extended: BX2000 completion moved from mid-2023 (Q3 guidance) to end-2023; BX3000 IND slipped from 1H 2023 to summer 2023, modestly pushing the NMB portfolio timeline .

Financial Results

MetricQ4 2021Q2 2022Q3 2022Q4 2022
Revenue, net ($USD Millions)$0.40 $0.30 $0.24 $0.31
Cost of Sales ($USD Millions)$0.58 $0.36 $1.21 $4.79
Research & Development ($USD Millions)$0.50 $0.91 $0.65 $1.04
Selling, General & Administrative ($USD Millions)$11.54 $4.03 $3.81 $2.09
GAAP Net (Loss) / Income ($USD Millions)$29.43 $(7.53) $(29.21) $(9.25)
GAAP Diluted EPS ($USD)$437.19 $(1.05) $(2.47) $(12.33)
Adjusted Net Loss (Non-GAAP) ($USD Millions)$(11.87) $(4.95) $(4.62) $(3.19)
Cash & Equivalents ($USD Millions)N/A$5.21 $5.65 $5.26

Notes:

  • Q4 2022 cost of sales increase primarily reflects a $4.44M non-cash inventory write-off .
  • Q4 2022 impairments: $1.94M ANJESO intangible and $0.50M construction-in-progress reduction .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BX1000 Phase II Enrollment CompletionQ1 2023Interim analyses early 2023; doses to progress in H1 2023 Enrollment complete Q1 2023 Clarified timeline (more specific)
BX1000 Phase II Top-line DataEarly Q2 2023Interim analyses validating attributes in H1 2023 Top-line early Q2 2023 Slight push to early Q2
BX2000 Phase I Dose Escalation Completion2023Complete by mid-2023 Complete by end of 2023 Lowered (delayed)
BX3000 IND Filing2023IND in 1H 2023 IND in summer 2023 Lowered (delayed)
ANJESO CommercializationOngoingContinued commercialization with volume growth YoY U.S. commercialization discontinued Lowered (exit)
Financing availabilityNear-term$6.2M offering in Sept 2022 $5.0M offering Dec 2022; $4.3M warrants exercised Jan 2023 Neutral-to-positive liquidity update

Earnings Call Themes & Trends

Note: A Q4 2022 earnings call transcript was not available in our document set. The table below tracks themes across company releases.

TopicPrevious Mentions (Q2 2022, Q3 2022)Current Period (Q4 2022)Trend
NMB Portfolio Progress (BX1000/BX2000)BX2000 Phase I started; BX1000 Phase II prep ; BX1000 Phase II underway; BX2000 cohorts enrolling BX1000 Phase II interim data positive; enrollment complete Q1’23; BX2000 completion end-2023 Advancing; more specific timelines
NMB Reversal (BX3000)IND 1H 2023 expectation IND targeted for summer 2023 Slight delay
ANJESO CommercializationQ2/Q3 reported modest revenue growth and end-user vial growth U.S. commercialization discontinued Strategic exit
Hospital Macro/COVID ConstraintsPersistent impacts on elective procedures and staffing in Q3 Economic challenges cited for ANJESO exit Ongoing pressure
Financing/Liquidity$2.0M (May) and $6.2M (Sept) offerings $5.0M (Dec) offering; $4.3M warrants exercised (Jan 2023) Liquidity maintained
Non-GAAP Focus/Cost ActionsSG&A reductions; adjusted loss trend improving Adjusted net loss improved; SG&A down sharply YoY Improving cost profile

Management Commentary

  • “During our fourth quarter we refocused our priorities on our NMB portfolio, initiating our Phase II trial for BX1000 and advancing our Phase I dose escalation trial for BX2000.” – Gerri Henwood, President & CEO .
  • “The encouraging interim data… showed all patients treated to date have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that BX1000 has been generally well tolerated.” .
  • “Due to persistent economic challenges facing hospitals… we have taken the strategic decision to discontinue commercialization of ANJESO.” .
  • “BX3000… we expect to complete the nonclinical and manufacturing studies needed to support an IND filing… in the summer of 2023.” .

Q&A Highlights

  • A Q4 2022 earnings call transcript was not available in our dataset, so Q&A highlights and guidance clarifications cannot be provided. We searched for “earnings-call-transcript” in the period and found none; a Special Call (Apr 25, 2023) transcript exists but was not retrievable due to a database inconsistency error (document 2) [2].

Estimates Context

  • Wall Street consensus estimates via S&P Global were unavailable for BXRX due to missing mapping in SPGI’s CIQ company table, preventing retrieval of EPS and revenue consensus for Q4 2022. As a result, we cannot provide comparisons to consensus estimates for this quarter [SpgiEstimatesError].
  • Given the unavailability of S&P Global consensus, we do not present estimate comparisons; investors should anticipate that sell-side models may revisit revenue assumptions given ANJESO discontinuation and shift toward NMB development .

Key Takeaways for Investors

  • BXRX has pivoted decisively from ANJESO commercialization to its NMB pipeline, with positive BX1000 interim data providing near-term clinical validation and an early Q2 2023 top-line catalyst .
  • Strategic exit from ANJESO reduced future commercial revenue but should lower SG&A and align capital with higher-potential NMB assets; adjusted net loss improved markedly YoY in Q4 .
  • Timeline slips (BX2000 completion to end-2023; BX3000 IND to summer 2023) modestly push development milestones, but the program remains active with defined next steps .
  • Liquidity actions ($5.0M Dec offering; ~$4.3M Jan warrant exercises) support execution into 2023, though additional financing may be needed to progress later-stage studies .
  • Near-term trading catalyst: BX1000 Phase II top-line in early Q2 2023; mid-’23/summer ’23 updates on BX3000 IND and BX2000 dosing could further shape sentiment .
  • No financial guidance provided; with estimates unavailable from S&P Global, focus shifts to clinical milestones and cost discipline to inform model updates [SpgiEstimatesError] .
  • Watch for management’s prioritization between BX1000 and BX2000 later in 2023, which could concentrate resources on the asset with the most favorable profile .