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Cerevel Therapeutics Holdings, Inc. (CERE)·Q2 2023 Earnings Summary

Executive Summary

  • Q2 2023 was a pre-revenue quarter; operating expenses were $96.8M and net loss was $(99.5)M, or $(0.63) per share, with weighted-average shares of 157.1M .
  • Cash, cash equivalents and marketable securities were $825.1M, which management expects to fund multiple 2024 data readouts and operations into 2025 .
  • Pipeline timing shifted: emraclidine Phase 2 schizophrenia (EMPOWER-1/2) data moved to 2H 2024; REALIZE (darigabat in focal epilepsy) remains mid-2024; ADAPT (darigabat in panic disorder) was initiated; tavapadon Phase 3 timing reaffirmed (TEMPO-3 1H 2024; TEMPO-1/2 2H 2024) .
  • Leadership strengthened with three new executives (CEO Ron Renaud, CFO Susan Altschuller, GC Paul Burgess); management emphasized execution ahead of a “pivotal year in 2024” .

What Went Well and What Went Wrong

What Went Well

  • Strong liquidity: $825.1M in cash, cash equivalents and marketable securities; runway expected into 2025 supporting multiple late-stage readouts .
  • Pipeline execution: ADAPT (darigabat in panic disorder) was initiated; TEMPO Phase 3 tavapadon timelines reaffirmed for 2024 .
  • Management tone focused on delivery: “We remain focused on execution as we prepare for a pivotal year in 2024 with data from multiple late-stage clinical trials in schizophrenia, epilepsy, and Parkinson’s disease.” — Ron Renaud, CEO .

What Went Wrong

  • Emraclidine Phase 2 schizophrenia (EMPOWER) timelines delayed to 2H 2024 due to slower U.S. enrollment and ex-U.S. site startup delays .
  • Net loss widened year over year (Q2 2023 $(99.5)M vs. $(90.5)M in Q2 2022); EPS $(0.63) vs. $(0.61), reflecting higher operating costs and financing liability fair value losses .
  • Other income swung to a loss ($(9.8)M) driven by fair value remeasurement losses on funding liabilities (NovaQuest/Bain) versus a gain in Q2 2022 .

Financial Results

Quarterly P&L progression (oldest → newest)

MetricQ4 2022Q1 2023Q2 2023
Research & Development ($USD Millions)$81.3 $78.2 $74.1
General & Administrative ($USD Millions)$25.9 $21.4 $22.8
Total Operating Expenses ($USD Millions)$107.2 $99.6 $96.8
Net Loss ($USD Millions)$(92.8) $(104.3) $(99.5)
Diluted EPS ($USD)$(0.59) $(0.67) $(0.63)
Weighted-Average Shares (Millions)156.4 156.6 157.1

Q2 year-over-year comparison

MetricQ2 2022Q2 2023
Research & Development ($USD Millions)$72.5 $74.1
General & Administrative ($USD Millions)$20.5 $22.8
Total Operating Expenses ($USD Millions)$93.0 $96.8
Net Loss ($USD Millions)$(90.5) $(99.5)
Diluted EPS ($USD)$(0.61) $(0.63)

KPIs

KPIQ1 2023Q2 2023
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$863.0 $825.1
Cash from Operations ($USD Millions)$(94.9) $(77.3) (derived from six-month $(172.25) minus Q1 $(94.92))
Interest Income, net ($USD Millions)$6.44 $9.82
Convertible Senior Notes (Net Carrying Amount, $USD Millions)$336.0 $336.4

Notes: Company reports no product revenue; it has not yet generated revenues as of June 30, 2023 .

Segment breakdown: Not applicable (pre-revenue) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Emraclidine (EMPOWER-1/-2) Schizophrenia Phase 2 – Data timing20241H 2024 2H 2024 Delayed
Darigabat (REALIZE) Focal Epilepsy – Data timing2024Delay beyond 2023; timing to be updated by mid-year Mid-year 2024 Clarified/Firmed
Darigabat (ADAPT) Panic Disorder – Trial status2023Initiation expected in Q2 2023 Trial initiated Initiated
Tavapadon (TEMPO-3) Adjunctive PD – Data timing2024Mid-year 2024 1H 2024 Maintained/Refined
Tavapadon (TEMPO-1/-2) Monotherapy PD – Data timing20242H 2024 2H 2024 Maintained
CVL-871 Dementia-related Apathy – Timeline20242H 2024 Timeline under review Under Review/Delayed
Cash runwayThrough 2025Into 2025 Into 2025 Maintained

Earnings Call Themes & Trends

Note: The Q2 2023 earnings call transcript could not be retrieved due to a database inconsistency; themes reflect prepared remarks and MD&A.

TopicPrevious Mentions (Q4 2022, Q1 2023)Current Period (Q2 2023)Trend
Enrollment & timelinesREALIZE timing impacted by post‑COVID environment; tavapadon and emraclidine timelines outlined EMPOWER schizophrenia delayed to 2H 2024 due to slower U.S. enrollment and ex‑U.S. site startup delays Headwind persists (slower enrollment)
Pipeline executionEmraclidine Phase 1 BP trial positive; tavapadon Phase 3 ongoing; ADAPT planned ADAPT trial initiated; TEMPO timelines reaffirmed; EMPOWER-3 OLE ongoing Execution continues; mixed (delay + starts)
Liquidity & funding$950.2M cash at YE22; funding agreements inflows; runway into 2025 $825.1M cash & securities; ops funded into 2025 Strong but declining balance (burn)
LeadershipCEO transition to Ron Renaud announced; board changes Three exec additions including CEO, CFO, GC; focus on execution Strengthened mgmt bench
Regulatory/designationsEmraclidine Fast Track (AD psychosis) Fast Track reiterated; registrational-supportive nonclinical/pharmacology prioritization Continued engagement
Financing liabilities & other incomeGains in fair value remeasurement in 2022 Losses in fair value remeasurement in Q2 2023 Volatility in other income line

Management Commentary

  • “We remain focused on execution as we prepare for a pivotal year in 2024 with data from multiple late-stage clinical trials in schizophrenia, epilepsy, and Parkinson’s disease.” — Ron Renaud, President & CEO .
  • Emraclidine EMPOWER trials data timing moved to 2H 2024 due to slower-than-expected U.S. enrollment and ex-U.S. site startup delays; EMPOWER-3 OLE continues; registrational-enabling nonclinical/clinical pharmacology studies prioritized .
  • Liquidity: cash, cash equivalents and marketable securities of $825.1M; expected to support 2024 readouts and fund operations into 2025 .
  • Other income: the quarter reflected net losses from fair value remeasurement of funding liabilities due to changes in market inputs and passage of time .

Q&A Highlights

  • The Q2 2023 earnings call transcript was not retrievable due to a database inconsistency; no Q&A themes are available from the transcript. This recap reflects prepared remarks and the 10‑Q MD&A .

Estimates Context

  • Wall Street consensus (S&P Global) estimates for revenue and EPS were unavailable; a GetEstimates request returned a Capital IQ mapping error for CERE, so comparisons vs. consensus could not be performed.*

*Estimates would typically be retrieved from S&P Global; unavailable for this period due to mapping error.

Key Takeaways for Investors

  • Cerevel remains pre‑revenue but is well capitalized ($825.1M) with runway into 2025, enabling multiple late‑stage readouts in 2024 .
  • Emraclidine timeline delay (to 2H 2024) is a near‑term sentiment headwind; management is prioritizing registrational-enabling workstreams to support the package .
  • Execution continues across programs: TEMPO tavapadon Phase 3 readouts in 2024; REALIZE mid‑2024; ADAPT initiated in panic disorder .
  • Watch the “Other income (expense)” line; fair value marks on funding liabilities can swing quarterly results independent of core operating progress .
  • Convertible senior notes ($345M principal, 2.50% due 2027) represent potential dilution at ~$46.38 conversion price; settlement flexibility (cash/stock) provides levers near maturity .
  • Leadership additions (CEO/CFO/GC) and explicit 2024 catalyst stack position the story for binary data events; timeline clarity and enrollment cadence are key to thesis and trading set‑ups .

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