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BT

Better Therapeutics, Inc. (BTTX)·Q2 2023 Earnings Summary

Executive Summary

  • FDA authorized AspyreRx in July 2023; management set a Wholesale Acquisition Cost at $750 for a 90‑day script and targeted a commercial launch in Q4 2023, establishing key pre‑launch economics and timing .
  • Q2 operating expenses fell 27% YoY driven by R&D reductions post pivotal trial; net loss improved to $7.6M ($0.24 EPS) from $9.9M ($0.42 EPS) a year ago, reflecting restructuring savings and lower insurance costs .
  • Liquidity remained constrained: cash was $6.2M at quarter‑end; financing in July added $6.7M net proceeds and the Hercules term loan amendment paused amortization to Nov 1, with runway expected into Q4 2023 .
  • Payer coverage engagement and real‑world evidence enrollment (~90%) progressed; management framed Q4 launch and initial coverage wins as near‑term catalysts for stock narrative evolution .

What Went Well and What Went Wrong

What Went Well

  • FDA authorization for AspyreRx created a new class of diabetes digital behavioral therapeutic devices, a pivotal corporate milestone and commercialization catalyst (“Obtaining FDA authorization for AspyreRx was a pivotal milestone…”) .
  • Pricing and launch metrics finalized: WAC set at $750 for 90 days with a cash‑pay option planned to support access at launch; SAM registration and Federal Supply Schedule access targeted, supporting channel readiness .
  • Cost discipline: R&D expense down to $2.2M (from $4.2M YoY) and G&A down to $3.1M (from $3.7M YoY) as restructuring benefits materialized, improving loss per share .

What Went Wrong

  • Liquidity and going‑concern risk: cash of $6.2M with runway only into Q4 2023 despite July financings; management disclosed substantial doubt about continuing as a going concern absent additional funding .
  • Debt burden and higher rates: interest expense rose to $0.6M (vs. $0.3M), reflecting Hercules loan draw and rate increases; covenants and subjective acceleration clauses add financing risk .
  • Nasdaq deficiencies: company received notices for minimum bid price and market value—highlighting capital‑markets overhang during commercialization ramp .

Financial Results

MetricQ4 2022Q1 2023Q2 2023
Revenue ($USD Millions)$0.00 $0.00 $0.00
R&D Expense ($USD Millions)$3.05 $3.39 $2.24
Sales & Marketing Expense ($USD Millions)$1.70 $2.10 $1.70
G&A Expense ($USD Millions)$3.58 $3.43 $3.08
Total Operating Expenses ($USD Millions)$8.32 $8.93 $7.03
Interest Expense, net ($USD Millions)$0.44 $0.43 $0.56
Net Loss ($USD Millions)$(8.77) $(9.36) $(7.59)
Diluted EPS ($)$(0.37) $(0.39) $(0.24)
Weighted Avg Shares (Millions)23.75 23.83 31.22
Net Income Margin %N/A (no revenue reported) N/A (no revenue reported) N/A (no revenue reported)
EBITDA Margin %N/A (no revenue reported) N/A (no revenue reported) N/A (no revenue reported)

Segment breakdown: Not applicable—no revenue and no segments reported .

KPIs and Balance Sheet

KPIQ4 2022Q1 2023Q2 2023
Cash & Cash Equivalents ($USD Millions)$15.74 $6.07 $6.20
Total Debt (Long-term + Current, net) ($USD Millions)$14.88 (net of issuance costs incl. end charge) $14.54 (net) $14.21 (net)
Current Portion of Long-term Debt ($USD Millions)$4.53 $5.54 $5.69
Capitalized Software Dev. Costs, net ($USD Millions)$3.89 $3.75 $3.58
WAC Price for AspyreRx ($ per 90 days)——$750.00
Real-world Evidence Enrollment (%)—~75% ~90% (as of 7/31/23)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AspyreRx Commercial Launch2023“Anticipating a commercial launch within a few months following FDA decision mid‑year” “Expected to launch commercially in Q4 2023” Timing clarified to Q4 (schedule firmed)
AspyreRx PricingAt launchNot disclosedWAC set at $750 for 90‑day script; cash‑pay option planned New disclosure
Cash Runway2023Operating cash burn to be ~$10M lower in 2023 (from restructuring) Runway extended “into the fourth quarter” post July financings and loan amendment Maintained cost focus; runway still tight
Real‑world Evidence DataQ4 2023Interim dataset expected Q4 2023 ~90% enrolled by 7/31/23; first dataset expected Q4 2023 (pending power) Progressing as planned
SAM/Federal Supply Schedule Access2023Not previously specifiedSAM registration underway; negotiation for Federal Supply Schedule access post‑registration New operational milestone

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2022)Previous Mentions (Q1 2023)Current Period (Q2 2023)Trend
FDA Authorization & IndicationDe novo accepted; BT‑001 pivotal data published; launch prep for 2023 De novo review progressing; decision expected mid‑year FDA authorization achieved for AspyreRx; launch targeted Q4 2023 Clear advancement
Pricing & AccessNot disclosedNot disclosedWAC set at $750; plan for cash‑pay option; payer coverage engagement ongoing; SAM/FSS path Launch readiness improved
Payer Coverage DialoguesInitiated payer discussions, HEOR in motion Preparing pre‑authorization exchange; HEOR submission “Gaining broad payer coverage” a key priority; actively engaging payers Broadening engagement
Financing & RunwaySeeking options; cash $22.3M (Q3’22) $6.5M private placement; Hercules amendment Additional $6.7M net proceeds in July; runway into Q4; Hercules amortization paused Near‑term extended
R&D ExecutionBT‑001 pivotal conclusions; LivVita topline planned Q4’22 Responded to FDA RFI; team hires in medical/marketing Real‑world evidence ~90% enrolled; Breakthrough Device request for NAFLD/NASH planned by year‑end Execution continues

References include press release content; Q2 call transcript is available online if needed for verbatim Q&A elements .

Management Commentary

  • “Obtaining FDA authorization for AspyreRx was a pivotal milestone for our company and a catalyst for strengthening our financial position and advancing business development discussions.” — Frank Karbe, CEO .
  • “With a commercial release of AspyreRx anticipated later this year, gaining broad payer coverage and building awareness amongst targeted healthcare providers is a key priority for us.” — Frank Karbe, CEO .
  • Launch readiness: WAC set at $750 for 90‑day treatment; cash‑pay option planned to support access while coverage is established .
  • Operational milestones: SAM registration and Federal Supply Schedule access targeted; real‑world evidence interim dataset expected Q4 2023 .

Q&A Highlights

  • Pricing and affordability: Management reiterated WAC of $750 for 90 days and discussed a cash‑pay option to bridge access while coverage scales .
  • Payer coverage process: Engagements with multiple payers advancing; emphasis on clinical data, HEOR and real‑world evidence as key levers for coverage decisions .
  • Financing and runway clarity: July financings and Hercules amendment extended runway into Q4 2023; management indicated further efforts to strengthen balance sheet as commercialization ramps .

Estimates Context

  • Wall Street consensus via S&P Global: Not available for BTTX during Q2 2023 due to missing CIQ mapping; therefore, we cannot provide formal “vs. estimates” comparisons. Where “beats/misses” are mentioned in third‑party transcripts, they are not anchored to S&P Global and are not used for this report [SpgiEstimatesError].

Key Takeaways for Investors

  • Near‑term catalyst path is clear: Q4 2023 commercial launch, initial payer coverage wins, and Q4 real‑world evidence interim data should drive narrative and potential re‑rating .
  • Established pricing at $750 for 90 days balances payer economics with planned cash‑pay access; pricing disclosure reduces launch uncertainty .
  • Cost discipline improved P&L: Operating expenses fell and EPS loss narrowed; however, ongoing interest expense and debt covenants remain watch points .
  • Liquidity remains tight: Runway only into Q4 2023; continued capital raising or partnership activity likely needed to sustain commercialization .
  • Regulatory momentum beyond T2D: Breakthrough Device request for NAFLD/NASH planned by year‑end; platform optionality could support medium‑term thesis .
  • Market‑access execution is central: SAM/Federal Supply Schedule progress plus payer dialogues position AspyreRx for broader coverage; watch for coverage announcements and HEOR publications .

Citations:

Transcript sources: