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Verastem, Inc. (VSTM)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 operating expenses were $16.8M; R&D $10.7M and SG&A $6.1M. GAAP net loss was $16.8M ($0.08 per share) and non-GAAP adjusted net loss was $15.4M ($0.08 per share). Ending cash, cash equivalents and investments were $87.9M; pro forma cash was $117.9M including January 27, 2023 preferred financing .
  • Management outlined 2023 priorities: initiate LGSOC confirmatory study (RAMP 301), advance KRAS G12C NSCLC combinations (RAMP 203/204), and progress RAMP 205 in frontline metastatic pancreatic cancer; cash runway bolstered by Oxford facility and BVF preferred financing .
  • The quarter maintained disciplined OpEx with sequential declines vs Q3 and Q2 as program phasing reduced investigator and drug product costs; SG&A increased modestly year over year in anticipation of potential commercialization in LGSOC .
  • No formal financial guidance or revenue outlook was provided; focus remains on clinical milestones and regulatory path for avutometinib + defactinib in recurrent LGSOC .

What Went Well and What Went Wrong

What Went Well

  • Positive interim data from RAMP 201 supported selection of the avutometinib + defactinib combination in recurrent LGSOC and planning of a confirmatory study: “we are working rapidly to bring forward the first U.S. Food and Drug Administration (FDA)-approved therapy for these patients” .
  • Strengthened balance sheet: ended FY22 with $87.9M cash and short-term investments; closed $30M Series B preferred tranche and unlocked an additional $15M term loan capacity under Oxford Loan Agreement .
  • Development momentum across RAS pathway-driven tumors with initial read-outs planned in KRAS G12C NSCLC combinations and dose selection in RAMP 205 pancreatic cancer .

What Went Wrong

  • Continued GAAP and non-GAAP losses as the company remains pre-commercial: Q4 GAAP net loss $16.8M ($0.08 per share) and non-GAAP adjusted net loss $15.4M ($0.08 per share) .
  • SG&A up year over year in Q4 due to commercialization readiness costs despite overall OpEx control, highlighting near-term cost pressure before potential revenue inflection .
  • Revenue remains minimal/irregular (driven by COPIKTRA milestone economics rather than product sales), keeping P&L leverage back-end loaded on clinical/regulatory outcomes .

Financial Results

MetricQ2 2022Q3 2022Q4 2022
Total Operating Expenses ($USD Millions)$21.402 $17.7 $16.8
R&D Expense ($USD Millions)$14.888 $11.3 $10.7
SG&A Expense ($USD Millions)$6.514 $6.4 $6.1
GAAP Net Loss ($USD Millions)$(21.952) $(18.1) $(16.8)
GAAP EPS (basic & diluted)$(0.12) $(0.09) $(0.08)
Non-GAAP Adjusted Net Loss ($USD Millions)$(20.100) $(16.6) $(15.4)
Non-GAAP EPS (diluted)$(0.11) $(0.08) $(0.08)
Cash, Cash Equivalents & Investments ($USD Millions)$94.3 $104.0 $87.9
Pro Forma Cash ($USD Millions)N/AN/A$117.9 (incl. $30M preferred)

Note: Q2 revenue was $0.0M vs $0.5M in Q2 2021 (transition/license economics) . Q3/Q4 revenue detail not disclosed in press releases; full-year 2022 revenue was $2.6M (COPIKTRA-related milestone) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial revenue/margins/OpExFY2023None providedNone providedMaintained (no formal financial guidance)
LGSOC program (avuto + defactinib)2023Registration-directed trial underway (RAMP 201)Initiate confirmatory study upon FDA design agreement; timing of accelerated approval filing based on data maturityRaised program specificity (confirmatory plan)
KRAS G12C NSCLC combos (RAMP 203/204)2023Ongoing enrollmentInitial safety/efficacy read-outs in 2H-2023; determine recommended Phase 2 doseTimeline specified (milestone guidance)
Pancreatic cancer (RAMP 205)2023InitiatedDetermine RP2D; complete initial Phase 2 expansion cohort enrollmentTimeline specified (execution milestones)
Liquidity/financing2023Oxford facility available$30M preferred closed; unlocked $15M Term B; strengthened runway to deliver milestonesImproved liquidity

Earnings Call Themes & Trends

Transcript was not available in our document corpus or via verified sources; themes inferred from sequential company press releases.

TopicPrevious Mentions (Q-2)Previous Mentions (Q-1)Current Period (Q4 2022)Trend
LGSOC clinical path (RAMP 201)Interim analysis; responses in KRAS mutant and wild-type; decision deferred pending data maturity Encouraging interim results; Q4 FDA meeting confirmed Positive interim data; go-forward combo selected; confirmatory study planned Strengthening toward confirmatory pathway
KRAS G12C NSCLC (RAMP 203/204)Enrollment continues; initial results expected 2H 2022 Programs on track; IP allowed for combo dosing Advance to initial read-outs; dose recommendations expected Continuing execution; nearer to read-outs
Pancreatic cancer (RAMP 205)PanCAN Therapeutic Accelerator Award; trial initiation Ongoing program preparation Determine RP2D and complete early Phase 2 cohort enrollment Progressing per plan
Financing/liquidity$94.3M cash; runway to at least 2025 based on Oxford/milestones $104.0M cash; continued access to facility $87.9M year-end cash; $30M preferred closed; $15M additional term loan available Strengthened with preferred and debt access
RegulatoryBreakthrough Therapy designation reiterated FDA interactions ongoing for regimen selection Confirmatory study design to be finalized; accelerated approval timing linked to data maturity Advancing toward potential filing

Management Commentary

  • “Building on the Breakthrough Therapy designation for the combination of avutometinib with defactinib in recurrent LGSOC and the positive results from the interim analysis of Part A of the RAMP 201 trial, we are working rapidly to bring forward the first U.S. Food and Drug Administration (FDA)-approved therapy for these patients who deserve better options.” — Brian Stuglik, CEO .
  • “We plan to efficiently advance our development program and provide early data read-outs with avutometinib combinations across other RAS pathway-driven cancers with high unmet need, including combinations in KRAS G12C mutant NSCLC and frontline metastatic pancreatic cancer.” — Brian Stuglik, CEO .
  • “In the second quarter, we announced findings from the interim analysis of our registration-directed RAMP 201 trial... and are encouraged by the anti-tumor activity... We look forward to evaluating a more mature data set to select the go forward regimen.” — Brian Stuglik, CEO .

Q&A Highlights

An earnings call transcript for Q4 2022 could not be located in our document corpus; no verified transcript was available via company or SEC sources at the time of analysis. As a result, Q&A themes and guidance clarifications are unavailable.

Estimates Context

  • Wall Street consensus estimates (EPS, revenue) via S&P Global could not be retrieved due to data access limitations (daily request limit exceeded). As such, comparisons to consensus for Q4 2022 are unavailable at this time. If needed, we can re-run SPGI queries when access resets and update this section accordingly.

Key Takeaways for Investors

  • The LGSOC program de-risked further with positive interim data and a defined confirmatory pathway; regulatory momentum and Breakthrough Therapy designation underpin the near-term catalyst stack .
  • OpEx trended down sequentially through Q2→Q3→Q4, reflecting disciplined spend and program phasing; SG&A year-over-year growth is commercialization prep-related, a constructive sign for launch readiness .
  • Liquidity strengthened via preferred equity and incremental debt availability; year-end cash of $87.9M supports 2023 execution milestones and potential regulatory filing steps .
  • Multiple read-outs across KRAS G12C NSCLC combinations and pancreatic cancer in 2023 offer optionality for broader RAS pathway footprint beyond LGSOC .
  • Near-term stock reaction likely tied to confirmatory study initiation and additional RAMP 201 data disclosures; medium-term thesis centers on accelerated approval viability and combo differentiation in RAS-driven cancers .
  • Absence of revenue guidance and reliance on milestones maintain binary event risk; attention should focus on data quality, safety profile durability, and FDA alignment milestones .
  • Revisit estimates context when SPGI access resets to assess potential upward/downward revisions tied to clinical/regulatory cadence.