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NewAmsterdam Pharma Co N.V. (NAMS)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was execution-heavy: PREVAIL CVOT surpassed 9,500 randomized patients, TANDEM (FDC with ezetimibe) began dosing, and cash rose to $481.1M after a February follow-on, extending runway toward pivotal readouts (BROOKLYN 3Q24, BROADWAY 4Q24; TANDEM 1Q25) .
  • Financials reflected R&D scale-up and non-cash mark-to-market: revenue was $1.4M (license-related), R&D $42.4M, SG&A $14.5M; net loss widened to $93.8M ($1.06/sh) driven by a $39.0M fair value loss on earnout/warrants and FX .
  • The company reiterated clinical timelines and highlighted differentiation (Lp(a) lowering, small dense LDL particle reductions, potential diabetes benefit) as commercialization themes; management showcased payer receptivity and primary care potential for an oral agent on a May 16 special call .
  • Key stock catalysts in the next 6–9 months: BROOKLYN (3Q24) and BROADWAY (4Q24) LDL-C Phase 3 topline; additional clarity from TANDEM (1Q25) and ongoing PREVAIL progress; investor R&D communication cadence remains active .

What Went Well and What Went Wrong

  • What Went Well
    • PREVAIL CVOT enrollment completed ahead of plan with >9,500 patients randomized, enhancing statistical power and duration for outcomes assessment .
    • Balance sheet strengthened: cash increased to $481.1M (from $340.5M at 12/31/23) following a $190.0M net follow-on; supports completion of pivotal program and pre-launch activities .
    • Strategic positioning: management emphasized oral CETP differentiation (robust Lp(a) effects, small LDL particle reduction, potential diabetes benefit) and reported constructive payer dialogues about unmet need and coverage frameworks .
  • What Went Wrong
    • YoY revenue step-down to $1.4M from $8.6M due to absence of 2023-like milestone recognition; underscores limited near-term P&L offsets during heavy R&D spend .
    • Net loss widened to $93.8M, pressured by non-cash fair value loss on earnout/warrants ($39.0M) and FX losses ($2.4M), highlighting sensitivity to share price/warrant dynamics and currency .
    • SG&A grew to $14.5M (+79% YoY) as the organization scales for commercialization, raising scrutiny on operating leverage absent product revenue .

Financial Results

Metric (USD)Q1 2023Q1 2024
Revenue ($MM)$8.629 $1.401
Research & Development ($MM)$40.420 $42.430
Selling, General & Administrative ($MM)$8.062 $14.453
Total Operating Expenses ($MM)$48.482 $56.883
Operating Loss ($MM)$(39.853) $(55.482)
Interest Income ($MM)$0.943 $3.083
Fair value change – earnout & warrants ($MM)$(6.175) $(38.950)
FX gains/(losses) ($MM)$3.067 $(2.418)
Net Loss ($MM)$(42.018) $(93.767)
Diluted EPS ($)$(0.51) $(1.06)
Cash & Equivalents (end of period, $MM)$441.312 $481.147
Shares Outstanding (end of period)81,767,812 89,720,836

Notes:

  • Revenue reflects Menarini license-related recognition; the company has no product sales to date .

KPIs/Execution

  • PREVAIL CVOT enrollment randomized >9,500 (completed April 2024) .
  • TANDEM (FDC obicetrapib+ezetimibe) first patient dosed March 2024 .
  • BROOKLYN (HeFH) topline 3Q24; BROADWAY (ASCVD/HeFH) topline 4Q24 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough key readouts“Sufficient to fund operations through 2026” (Nov-2023; Jan-2024) Implicitly maintained given Q1 cash raise; no change disclosed in Q1 PR/10-Q Maintained
BROOKLYN topline20242H 2024 3Q 2024 Clarified timing
BROADWAY topline20242H 2024 4Q 2024 Clarified timing
PREVAIL enrollment2024Complete in 1Q 2024 Met target; >9,500 randomized (Apr 2024) Achieved
TANDEM topline20251Q 2025 1Q 2025 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2–Q3 2023)Current Period (Q1 2024)Trend
Clinical execution/enrollmentBROADWAY complete; PREVAIL on-track PREVAIL randomized >9,500; R&D Day outlined timelines Strengthened
Differentiation (Lp(a), small LDL, diabetes)Phase 2 data highlighted; positioning evolving Deep dive on Lp(a) waterfall, small particle reduction (~90%), anti-diabetes potential Increasing emphasis
Commercial readiness/payer viewTeam build, CCO/CFO hires Payers “receptive”; early adopters focus incl. primary care; launch playbook Maturing
Competition (oral PCSK9)Landscape acknowledged Oral PCSK9 viewed as market-expanding; obi profile positioned as superior on certain attributes Constructive
Imaging/REMBRANDTNot previously featuredNew CT-angio trial to visualize plaque impact of FDC; first patient randomized New initiative

Management Commentary

  • “We recently completed enrollment in PREVAIL… and initiated TANDEM… These trials, alongside BROOKLYN and BROADWAY, are expected to provide important insights into obicetrapib’s ability to potentially improve upon the existing standard of care.” — Michael Davidson, CEO .
  • “We believe that the market opportunity for obicetrapib is substantial… many… are not achieving LDL-C targets despite… statins and PCSK9 inhibitors.” — Michael Davidson, CEO .
  • Scientific positioning: CETP inhibition effects beyond LDL-C—including Lp(a) reductions, robust small LDL particle lowering, and potential diabetes benefits—were emphasized as clinical and commercial differentiators .

Q&A Highlights

  • Alzheimer’s biomarkers: Management targets statistically significant differences vs placebo in p-tau (217/181) among APOE4 carriers within BROADWAY biomarker analyses to inform Phase 3 decisioning .
  • Launch approach: Early adopters across specialists and high-prescribing primary care; targeted go-to-market mirroring past mass-market launches, tailored to lipid management .
  • Payer stance: Dialogues focus on unmet need and differentiation; tone characterized as “how to cover,” not “if,” pending data .
  • Imaging strategy: REMBRANDT CT-angiography study to support clinical narrative of plaque regression for the FDC; recognized as promotional (and potentially future label-supporting) evidence stream .
  • Competitive lens: Oral PCSK9s expected to aid category growth; obi profile (Lp(a), small particles, potential diabetes benefit) positioned to compete favorably .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable to us due to data access limits during this session; moreover, as a late-stage, pre-commercial biotech with license revenue only, many brokers do not publish quarterly EPS/revenue models comparable to commercial peers. Values retrieved from S&P Global were unavailable at time of request.*
  • The company provided no financial guidance; near-term investor models should focus on cash runway, R&D cadence, and binary clinical catalysts rather than quarterly P&L variability driven by non-cash fair-value and FX items .

Key Takeaways for Investors

  • Near-term data catalysts (BROOKLYN 3Q24, BROADWAY 4Q24) are primary stock drivers; positive LDL-C and secondary lipid endpoints would de-risk PREVAIL modeling and inform regulatory strategy .
  • PREVAIL enrollment (>9,500) and longer minimum follow-up aim for >20% MACE risk reduction based on modeled LDL/non-HDL/ApoB deltas; outcome remains pivotal for value realization .
  • Differentiation matters: Compelling signals on Lp(a) lowering and small dense LDL particle reduction, plus a plausible diabetes benefit mechanism, could support payer and prescriber adoption against oral PCSK9 competition .
  • Commercial setup advancing: Cash of $481.1M and maintained runway toward 2026 enable completion of pivotal trials and foundational pre-launch work; organizational scale-up is underway .
  • Watch non-cash P&L noise: Fair-value remeasurement of warrants/earnout and FX can obscure operating trends; focus on cash burn, trial milestones, and balance sheet sufficiency .
  • Imaging evidence (REMBRANDT) could augment clinical narrative for the FDC post-PREVAIL, aiding promotional uptake and potentially supporting future regulatory interactions .

Additional detail and source references

  • Q1 2024 earnings press release (8-K 2.02): financials, cash, milestones .
  • Q1 2024 10-Q: full financial statements and MD&A .
  • Special Call (May 16, 2024) transcript: scientific differentiation, payer/commercial, imaging, Q&A .
  • Prior quarters for trend context: Q3 2023 6-K and highlights ; Q2 2023 6-K and highlights .

*Estimates disclaimer: Consensus estimates from S&P Global could not be retrieved at the time of analysis due to access limits; comparisons vs consensus are therefore not provided. Values retrieved from S&P Global.