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Better Therapeutics, Inc. (BTTX)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 was a transition quarter: FDA authorization (July) and commercial launch (October) of AspyreRx, with initial prescriptions, while operating expenses fell 51% YoY and net loss improved materially to $5.9M ($0.15 EPS) from $11.4M YoY .
  • No product revenue recognized in Q3; management reiterated revenue will begin post-launch and expects to share revenue guidance only after 2–3 quarters of commercial experience; pro forma cash was ~$9.5M including October ATM proceeds, with runway into Q1 2024 .
  • Payer coverage is the core near-term catalyst; management signaled advanced discussions and targeted first commercial payer agreement by year-end; BD partnership and FDA Breakthrough Device Designation submission for MASLD/MASH also targeted by year-end .
  • Stock reaction catalysts: first payer coverage decision, BD partnership announcement, and Breakthrough Device submission outcome; runway and Nasdaq compliance risks remain (reverse split authority approved; going concern highlighted) .

What Went Well and What Went Wrong

What Went Well

  • FDA authorization of AspyreRx (De Novo) and completion of commercial launch preparations; management: “We made tremendous progress in Q3…” (Frank Karbe) .
  • Operating discipline: total operating expenses down to $5.3M (−51% YoY) driven by R&D, G&A reductions; net loss improved to $5.9M vs. $11.4M YoY .
  • Real-world evidence program reached 1,000 participants; MASLD/MASH LivVita study results published, supporting Breakthrough Device submission plans .

What Went Wrong

  • Pre-revenue quarter; management reiterated revenue will begin post-launch and formal revenue guidance will wait 2–3 quarters, delaying visibility .
  • Liquidity and going concern: cash $6.6M at quarter-end; runway only into Q1 2024; dependence on ATM raises and financing; Hercules loan amortization resumed Nov 1 .
  • Nasdaq deficiencies and shareholder-approved reverse split authority highlight listing risk amid limited market cap and bid price compliance .

Financial Results

MetricQ3 2022Q1 2023Q2 2023Q3 2023
Revenue ($USD Millions)$0.00 $0.00 $0.00 $0.00
Total Operating Expenses ($USD Millions)$11.00 $8.93 $7.03 $5.34
Operating Income ($USD Millions)$(11.00) $(8.93) $(7.03) $(5.34)
Net Income - (IS) ($USD Millions)$(11.41) $(9.36) $(7.59) $(5.86)
Diluted EPS - Continuing Operations ($USD)$(0.48) $(0.39) $(0.24) $(0.15)
Cash And Equivalents ($USD Millions)N/A$6.07 $6.20 $6.60

KPIs and Operating Details:

KPIQ3 2022Q1 2023Q2 2023Q3 2023
AspyreRx Wholesale Acquisition Cost (90-day)N/AN/A$750.00 $750.00
Self-pay Price (90-day, limited time)N/AN/APlanned $65.00
Real-world Evidence EnrollmentN/A~75% enrolled ~90% enrolled 1,000 participants completed
GLP-1 Adjunct Data AnnouncedN/AN/AN/ASubgroup showed superior outcomes with AspyreRx+GLP-1 vs. control using GLP-1
Pro forma cash incl. Oct ATM ($USD Millions)N/AN/AN/A~$9.5

Expense Breakdown (Q3 2023 vs. prior periods):

Metric ($USD Millions)Q3 2022Q1 2023Q2 2023Q3 2023
Research & Development$5.48 $3.39 $2.24 $1.83
Sales & Marketing$1.56 $2.10 $1.70 $1.39
General & Administrative$3.96 $3.43 $3.08 $2.12
Interest Expense, net$0.41 $0.43 $0.56 $0.52

Estimates vs. Actuals (Q3 2023):

MetricConsensus (S&P Global)ActualSurprise
EPS ($USD)Unavailable (mapping not available)$(0.15) Beat by $0.05 (third-party)
Revenue ($USD)Unavailable (mapping not available)$0.00 Inline at $0.00

Note: S&P Global consensus unavailable due to missing CIQ mapping for BTTX; third-party reference shown solely for context .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue GuidanceQ4 2023–FY 2024None provided Will begin sharing after 2–3 quarters of launch dynamics Maintained none
Cash RunwayThroughInto Q4 2023 Into Q1 2024 (incl. Oct ATM) Raised runway
Payer Coverage Milestone2023 year-endExpected post-FDA Expect first commercial payer agreement by year-end Clarified timing
Business Development Partnership2023 year-endExploring Expect announcement by year-end Added timeline
Breakthrough Device Designation (MASLD/MASH)2023 year-endSubmit in Q3 2023 Intend to submit by end of 2023 Timing reaffirmed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1, Q2)Current Period (Q3 2023)Trend
Commercial Launch & PricingLaunch anticipated Q4; WAC set at $750; self-pay planned AspyreRx commercially launched; initial prescriptions; self-pay at $65 for 90 days Execution progressing
Payer CoveragePursuing coverage; SAM/FSS process Advanced discussions; first agreement expected by year-end; VA FSS application submitted Positive momentum
RWE & Clinical Data75–90% RWE enrollment; LivVita positive topline RWE reached 1,000; LivVita published; GLP‑1 adjunct subgroup data Evidence building
AI/Tech & IPPlatform CBT focusEU patent issued covering predictive analytics and machine learning Strengthening IP
Financing & RunwayRestructuring; $6.5M private placement July equity/ATM; October ATM $2.9M; runway into Q1 2024 Extending runway
Regulatory/ListingFDA decision pendingFDA authorization achieved; reverse split authority approved to address Nasdaq deficiencies De-risked FDA; listing risk persists

Management Commentary

  • “We made tremendous progress in Q3, which included the FDA authorization of AspyreRx and the completion of the work required for a commercial launch in early October.” — Frank Karbe, CEO .
  • “Our current focus is on demonstrating commercial traction… Securing payer coverage is a critical element… advanced our discussions with multiple commercial payers…” — Frank Karbe .
  • “Cash and cash equivalents were $6.6 million on September 30, 2023… In October 2023, we raised $2.9 million through our ATM facility… extends our financial runway into the first quarter of 2024.” — Company release .
  • “Our plan is to begin sharing guidance once we have obtained a solid understanding of our launch dynamics, which we expect to take at least two to three quarters of commercial experience.” — Management on call .
  • “Self-pay option… price is $65 for a 90-day treatment period… providers [are] complimentary on this price point.” — Diane Gomez‑Thinnes, CCO .

Q&A Highlights

  • Payer coverage path: Management emphasized varied payer processes, growing funnel of engaged payers, and success advancing reviews with key decision-makers; PDT category novelty cited as a hurdle but long-term proposition compelling .
  • Guidance: Company will defer revenue guidance until 2–3 quarters of experience post-launch to understand dynamics .
  • Financing/Loan: Confirmation that Hercules loan amortization restarted on November 1, indicating resumed cash outflows for debt service .
  • Commercial footprint/geographies: Initial target geographies and sales focus aligned with payer efforts to optimize early traction .

Estimates Context

  • S&P Global consensus estimates were unavailable due to missing CIQ mapping for BTTX; therefore, we cannot present SPGI-based consensus comparisons for revenue or EPS this quarter.
  • Third-party summaries indicated Q3 EPS of $(0.15) was a $0.05 beat and revenue was $0.00 (inline), consistent with pre-revenue status pre-launch .
  • Implication: Sell-side models should focus on payer coverage pace, cash-pay adoption, and RWE/health economic evidence shaping reimbursement and trajectory.

Key Takeaways for Investors

  • Coverage catalyst: First commercial payer decision (targeted by year-end) and BD partnership announcement are the most immediate stock movers; monitor VA FSS progress for access to Veterans .
  • Liquidity runway: Cash into Q1 2024 suggests urgency for coverage traction and financing; expect continued ATM utilization or strategic capital, with going concern and Nasdaq compliance risks top of mind .
  • Commercial execution: Early prescriptions and $65 self-pay offer may seed utilization while coverage ramps; the $750 WAC sets the reimbursement anchor .
  • Evidence momentum: RWE enrollment completion and GLP‑1 adjunct data strengthen clinical/economic narrative; Breakthrough Device submission for MASLD/MASH could expand optionality .
  • Operating leverage: Expense base down materially; note one‑time reversal of a $1.5M payroll accrual in Q3 (non-recurring tailwind to expenses/liabilities) .
  • Debt service: Hercules amortization resumed Nov 1; rising interest costs constrain runway, adding execution pressure on coverage and partnerships .
  • Trade setup: Near-term trades hinge on coverage headline timing/quality; medium-term thesis depends on sustained uptake, reimbursement breadth, and evidence translating into payer economics.