Sign in

You're signed outSign in or to get full access.

BT

Better Therapeutics, Inc. (BTTX)·Q1 2023 Earnings Summary

Executive Summary

  • The quarter was primarily operational: Better Therapeutics expects an FDA decision on its de novo submission for BT-001 “within the next 90 days,” positioning for a potential commercial launch in T2D a few months thereafter if authorized .
  • Liquidity actions extended runway: a $6.5M private placement (7,878,786 shares at $0.825) and an amended Hercules loan delaying principal payments up to six months; cash fell to $6.1M at quarter-end from $15.7M in Q4 .
  • Cost discipline: the company implemented a ~35% workforce reduction and other savings; operating cash burn for 2023 expected to be ~$10M lower than previously forecast (Q4 release), signaling tighter expense control heading into anticipated launch preparations .
  • Compliance and milestones: BTTX regained Nasdaq continued listing compliance via market value standard on Apr 24 following an earlier deficiency notice, and targets Breakthrough Device designation submission for NAFLD/NASH in Q3 2023, with real-world evidence enrollment for BT-001 ~75% complete .
  • Estimates context: Wall Street consensus (S&P Global) for Q1 2023 EPS and revenue was unavailable; estimate comparisons cannot be provided (S&P Global data unavailable via tool).

What Went Well and What Went Wrong

What Went Well

  • Liquidity and runway extension: “The reduction in force, coupled with the completion of a private placement financing, extended our cash runway sufficiently to reach multiple significant milestones,” said President & CEO Frank Karbe .
  • Regulatory progress: The company responded to FDA’s Request for Additional Information on Apr 17; review is “progressing” and a decision is expected mid-year, supporting near-term commercialization planning .
  • Talent strengthening for commercialization: Hired Head of Marketing (ex-Novo Nordisk) and Head of Medical Affairs (ex-Abbott/Medtronic) to bolster launch readiness for BT-001 in T2D .

What Went Wrong

  • Cash drawdown: Cash and cash equivalents declined to $6.1M from $15.7M (Q4), reflecting continued operating losses and timing of financing; private placement closed in April after quarter-end .
  • Persistent losses: Net loss was $(9.4)M (EPS $(0.39)) vs $(9.7)M (EPS $(0.41)) in Q1 2022; interest expense rose to $0.4M vs $0.3M YoY due to incremental Hercules borrowing .
  • Nasdaq deficiency notice: Received a notice on Apr 5 for not meeting minimum stockholders’ equity; although compliance was later regained via market value, this highlights capital and listing risks .

Financial Results

MetricQ1 2022Q4 2022Q1 2023
Research & Development ($USD Millions)$3.673 $3.049 $3.389
Sales & Marketing ($USD Millions)$2.044 $1.695 $2.104
General & Administrative ($USD Millions)$3.628 $3.578 $3.432
Total Operating Expenses ($USD Millions)$9.345 $8.322 $8.925
Interest Expense, net ($USD Millions)$0.317 $0.439 $0.431
Net Loss ($USD Millions)$(9.662) $(8.765) $(9.357)
Net Loss per Share ($USD)$(0.41) $(0.37) $(0.39)
Weighted-Average Shares (Millions)23.413 23.746 23.827
Cash & Cash Equivalents ($USD Millions)—$15.740 (Dec 31, 2022) $6.068 (Mar 31, 2023)

Notes:

  • The Q1 2023 statement of operations presents operating expenses and losses without a revenue line; management did not report product revenue for the quarter .
  • Interest expense YoY increase is associated with prior incremental borrowing under the Hercules term loan .

KPIs and Operational Milestones

KPI / MilestoneQ3 2022Q4 2022Q1 2023
FDA de novo status for BT-001De novo request accepted for substantive review (Oct 2022) Received FDA RAI Feb 2023; working to address Responded Apr 17; FDA review progressing; decision expected mid-year
BT-001 Real-World Evidence EnrollmentInitiated program; ongoing Program design communicated; interim results expected Q4 2023 ~75% enrolled; completion targeted by end of Q3; first dataset in Q4
NAFLD/NASH (LivVita)Topline Q4 results targeted Reported positive pilot (MRI-PDFF −16%, p=0.01) Applying for Breakthrough Device designation; submit in Q3 2023
Workforce / Opex Actions—Announced restructuring and savings ~35% workforce reduction implemented Mar 23
Financing & Liquidity—Cash $15.7M; operating cash burn for 2023 expected ~$10M lower vs prior forecast $6.5M private placement (April), Hercules loan amendment delaying principal up to six months

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA decision on BT-001 de novoMid-2023Mid-2023 (unchanged trajectory) “Within the next 90 days” from May 11 (mid-year timing) Maintained/Refined timing
BT-001 commercial launch (if authorized)Post-authorizationAnticipated mid-2023 launch “Commercial launch within a few months” after decision Maintained
RWE program (BT-001)2023Interim results expected Q4 2023 ~75% enrolled; completion by end of Q3; first dataset in Q4 Maintained with progress
Breakthrough Device (NAFLD/NASH)1H 2023Submission expected 1H 2023 Submission expected Q3 2023 Lowered/Deferred to Q3
Operating cash burnFY 20232023 burn expected ~$10M lower than prior forecast Reinforced via RIF and cost measures Maintained direction
Financing strategy2023Seeking capital to extend runway Targets BD partnership and/or royalty monetization to enhance position Expanded detail

Earnings Call Themes & Trends

Note: Full Q1 2023 transcript could not be retrieved due to a database inconsistency; themes reflect earnings materials and 8-K press releases.

TopicPrevious Mentions (Q3’22 and Q4’22)Current Period (Q1’23)Trend
Regulatory (FDA de novo)De novo accepted (Oct); addressing RAI in Feb Responded to RAI; decision expected mid-year Advancing toward decision
Commercial readinessBuilding access/CCO hire; mid-2023 launch prep Added Head of Marketing and Head of Medical Affairs for launch prep Strengthening launch team
Real-world evidenceProgram initiated; interim Q4 2023 ~75% enrolled; completion by end of Q3 On track/near completion
Liquidity/financingAssess financing options; cash $15.7M (Q4) $6.5M private placement; Hercules amendment; runway extension Improved near-term runway
Cost actions—RIF ~35%; other savings Cost-down measures
NAFLD/NASHPilot positive; planning BD submission 1H 2023 BD submission now expected Q3 2023 Slight delay
Nasdaq listing—Regained compliance via market value (Apr 24) after deficiency notice (Apr 5) Resolved (for now)

Management Commentary

  • “We successfully navigated several challenges in the first quarter of this year, laying the foundations for long-term success… [we] extended our cash runway sufficiently to reach multiple significant milestones,” said CEO Frank Karbe .
  • “We look forward to a decision from the FDA on our de novo submission within the next 90 days and remain focused on preparing for the potential commercial launch of BT-001 in type 2 diabetes” .
  • On upcoming milestones: potential FDA authorization and commercial launch; RWE dataset in Q4; Breakthrough Device application for NAFLD/NASH in Q3; and potential BD/royalty monetization to strengthen the financial position .

Q&A Highlights

  • Q1 2023 earnings call transcript was not available due to a retrieval/database inconsistency; Q&A highlights and clarifications cannot be provided from the call. The company scheduled its call for May 11, 2023 at 8:30 a.m. ET with webcast and replay links provided in the press release .

Estimates Context

  • Wall Street consensus estimates (S&P Global) for Q1 2023 EPS and revenue were unavailable via our S&P Global tool integration; we cannot provide beat/miss analysis against consensus for this quarter.
  • With no revenue reported and continuing operating losses, near-term investor focus remains on regulatory decision timing, launch execution readiness, and liquidity runway rather than top-line/EPS variances .

Key Takeaways for Investors

  • Near-term catalyst: FDA de novo decision for BT-001 expected mid-year; a positive decision would be a key stock driver with commercial launch targeted within months thereafter .
  • Liquidity improved post-quarter: $6.5M equity financing and Hercules loan amendment extend runway to reach milestones; monitor incremental BD or royalty monetization transactions for further de-risking .
  • Cost actions are material: ~35% workforce reduction and targeted savings underpin the ~$10M 2023 burn reduction vs prior forecast (Q4 commentary), supporting launch prep within constrained resources .
  • Execution focus: Buildout of commercial and medical leadership (ex-Novo Nordisk, ex-Abbott/Medtronic) suggests readiness to engage payers/providers and drive adoption if authorized .
  • Secondary pipeline: NAFLD/NASH BD designation submission in Q3 extends optionality beyond T2D; initial LivVita signal supports the platform’s broader cardiometabolic potential .
  • Listing risk moderated: Nasdaq deficiency notice was resolved via market value standard, but equity and market cap thresholds should be monitored until core fundamentals inflect post-authorization .
  • RWE as payer lever: ~75% enrollment with first dataset in Q4 could strengthen coverage discussions; robust real-world outcomes would be a medium-term adoption catalyst .