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NewAmsterdam Pharma Co N.V. (NAMS)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 revenue was $2.28M, up vs $1.40M in Q1 2024 and $1.72M in Q2 2023; net loss narrowed to $39.0M (EPS $(0.41)) from $93.8M in Q1, aided by favorable warrant/earnout fair-value changes, though operating loss remained heavy due to Phase 3 spend .
  • Reported positive topline BROOKLYN Phase 3 data in HeFH: LDL-C LS mean reduction −36.3% at day 84 and −41.5% at day 365 vs placebo; 51% achieved LDL-C <70 mg/dL; safety comparable to placebo—key stock narrative catalyst .
  • Strong liquidity: cash $430.7M at quarter-end; added $150M ATM capacity (TD Cowen) post-quarter to opportunistically bolster capital for pivotal readouts and launch readiness .
  • Near-term milestones maintained: BROADWAY topline expected Q4 2024; TANDEM topline expected Q1 2025; BROOKLYN full data at upcoming conference; PREVAIL CVOT fully enrolled—pipeline momentum intact .
  • Wall Street consensus estimates via S&P Global were unavailable at the time of writing; no beat/miss assessment possible; focus remains on clinical catalysts and cash runway [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • BROOKLYN met primary and secondary endpoints with durable LDL-C lowering through 52 weeks and favorable safety profile; “Adverse events and discontinuations due to side effects were similar to placebo” (CEO) .
  • Over half of treated patients reached guideline target LDL-C <70 mg/dL (51%), underscoring commercial potential in difficult-to-treat HeFH; Chief Scientific Officer emphasized consistency with Phase 2 data .
  • Capital position strengthened: $430.7M cash at 6/30 and post-quarter $150M ATM flexibility—supports Phase 3 readouts and pre-launch activities .

What Went Wrong

  • Operating loss remained high at $(52.6)M on modest revenue ($2.28M largely deferred license recognition); R&D and SG&A reflect scaling for pivotal program and commercialization .
  • Revenue visibility remains limited (no product sales); Q2 revenue rose YoY, but remains small and timing-dependent (deferred revenue recognition) .
  • No traditional quarterly earnings call transcript available for Q2; focus shifted to special call on BROOKLYN, leaving limited quarterly guidance granularity for financial metrics [ListDocuments earnings-call-transcript=0] .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Millions)$1.72 $1.40 $2.28
Operating Loss ($USD Millions)$(42.48) $(55.48) $(52.58)
Net Loss ($USD Millions)$(38.29) $(93.77) $(39.01)
Diluted EPS ($)$(0.47) $(1.06) $(0.41)
Operating Expenses ($USD Millions)Q2 2023Q1 2024Q2 2024
R&D$34.34 $42.43 $38.38
SG&A$9.86 $14.45 $16.48
Liquidity ($USD Millions)Dec 31, 2023Mar 31, 2024Jun 30, 2024
Cash and Equivalents$340.45 $481.15 $430.71
Actual vs S&P Global ConsensusQ2 2024
Revenue vs ConsensusN/A – S&P Global consensus unavailable at time of writing
EPS vs ConsensusN/A – S&P Global consensus unavailable at time of writing
EBITDA vs ConsensusN/A – S&P Global consensus unavailable at time of writing

Notes: S&P Global consensus estimates were not retrievable at the time of writing; beat/miss assessment is not provided.

Segment breakdown: Not applicable—no reported operating segments; Q2 revenue increase was due to recognition of previously deferred license revenue .

KPIs (Clinical, BROOKLYN)

KPI (BROOKLYN)Q2 2024
LDL-C LS mean reduction vs placebo (Day 84)−36.3%
LDL-C LS mean reduction vs placebo (Day 365)−41.5%
Patients achieving LDL-C <70 mg/dL51%
Discontinuation rate (obicetrapib vs placebo)7.6% vs 14.4%
TEAEs (any)63.7% obicetrapib vs 70.3% placebo

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BROOKLYN topline3Q 2024On-track to report in 3Q 2024 Positive topline announced July 29, 2024 Achieved
BROADWAY topline4Q 2024On-track for 4Q 2024 Expects topline in 4Q 2024 Maintained
TANDEM topline1Q 2025Expected 1Q 2025 Enrollment completed; topline expected 1Q 2025 Maintained/Affirmed
BROOKLYN full dataUpcomingNot previously specifiedFull results to be presented at a medical conference New timing detail
U.S. IP coverageThrough 2043Prior patent coverage earlier end dateComposition of matter patent extends protection to July 2043 Extended
Capital flexibilityN/APrior ATM agent; no sales under prior agreement Amended ATM with TD Cowen; up to $150M capacity Enhanced

No financial guidance (revenue, margins, OpEx, tax rate, dividends) was provided; guidance focused on clinical timelines and IP .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023)Previous Mentions (Q1 2024)Current Period (Q2 2024)Trend
R&D execution and Phase 3 momentumDetailed plan: BROOKLYN/BROADWAY/PREVAIL timelines; TANDEM planned PREVAIL enrollment completed; TANDEM initiated BROOKLYN topline positive; TANDEM enrollment completed; BROADWAY on-track Improving
Commercial readinessBuilding organization; capital raise supports readiness Pre-launch activities highlighted; R&D day scheduled Continued emphasis; strong cash and added ATM capacity Strengthening
Regulatory/IPStandard risk disclosures N/AU.S. composition of matter patent extends to 2043 Positive
Safety profile vs prior CETPN/AN/ASafety comparable to placebo; no BP increase; favorable AE profile Positive clarity
CV outcomes (PREVAIL) expectationsCVOT plans (topline 2026) PREVAIL fully enrolled Modeled 22–25% hypothetical MACE benefit from LDL-C reduction Increasing confidence
Financing strategy2024 offering; pro forma cash ~$500M Cash $481.1M Cash $430.7M; $150M ATM available Prudent flexibility

Management Commentary

  • “We were thrilled to recently announce positive and statistically significant topline data from the pivotal Phase 3 BROOKLYN trial… with over half of patients on obicetrapib achieving the LDL-C guideline directed treatment goal of less than 70 mg/dl.” — Michael Davidson, M.D., CEO .
  • “Obicetrapib has a substantial and rapid effect on LDL levels… enabling patients… to achieve their risk-based goals.” — Prof. John Kastelein, CSO (Special Call prepared remarks) .
  • “Observed to be generally well-tolerated with safety results comparable to placebo, with no increase in blood pressure or any difference from placebo in liver enzymes, hs-CRP, or renal function.” — Michael Davidson, M.D. .

Q&A Highlights

  • Durability of LDL-C reduction and implications for BROADWAY/PREVAIL: Lines for treatment vs placebo remained parallel; placebo-corrected difference ~40–42% through 1 year; supports >20% hypothetical MACE benefit in PREVAIL modeling .
  • Safety and discontinuation rates: Lower discontinuations vs placebo (7.6% vs 14.4%); AE profile similar to placebo; clinicians emphasize safety as a key adoption driver .
  • Background therapy and efficacy: Efficacy consistent regardless of concomitant ezetimibe/PCSK9; BROADWAY patients generally easier to treat than BROOKLYN’s challenging HeFH cohort .
  • Potential metabolic benefits: Early signals on new-onset diabetes favorable; more data expected with BROADWAY .
  • Compliance and measurement: PK confirmed adherence; median LDL-C reduction ~40% at day 84; LDL measured consistently across methods .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 EPS, revenue, and EBITDA were unavailable at the time of writing; a beat/miss assessment versus Wall Street expectations is therefore not provided (S&P Global retrieval error).

Key Takeaways for Investors

  • Positive BROOKLYN topline de-risks LDL-lowering efficacy and safety for obicetrapib, strengthening the probability of favorable BROADWAY outcomes in ASCVD/HeFH and supporting regulatory paths .
  • Near-term catalysts are stacked: BROADWAY topline in Q4 2024, BROOKLYN full dataset presentation, TANDEM topline in Q1 2025, and PREVAIL outcomes in 2026—each with potential to re-rate the equity on efficacy/safety readouts .
  • Capital runway and flexibility are solid (Q2 cash $430.7M; $150M ATM capacity added), enabling continued Phase 3 execution and commercial build-out without immediate dilutive raises if markets are unfavorable .
  • IP extended to 2043 via new U.S. composition of matter patent, increasing the strategic value of obicetrapib and potential launch longevity .
  • Financials remain typical of late-stage biotech: minimal revenue from deferred license recognition and substantial OpEx; core stock narrative rests on clinical milestones, differentiation vs prior CETP class, and safety/tolerability profile .
  • Watch for detailed biomarker data (HDL, non-HDL, ApoB, Lp(a)) at upcoming conferences—could broaden differentiation and outcomes linkage ahead of PREVAIL .
  • Trading implications: Expect event-driven volatility around BROADWAY Q4 readout; positioning ahead of full BROOKLYN data and BROADWAY topline may be favored by investors comfortable with CV risk-reduction precedents tied to LDL-C lowering .

Sources: Q2 2024 8-K and Exhibit 99.1 press release, financial tables ; special call transcript ; BROOKLYN topline 8-K and exhibits ; Q1 2024 8-K ; FY2023 update 8-K ; ATM 8-K .