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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
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)
Guidance Changes
No financial guidance (revenue, margins, OpEx, tax rate, dividends) was provided; guidance focused on clinical timelines and IP .
Earnings Call Themes & Trends
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 .