NewAmsterdam Pharma Co N.V. (NAMS)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 capped a transformative year: positive Phase 3 topline readouts (TANDEM and BROADWAY) with robust LDL-C lowering and favorable safety; EMA submission by partner Menarini targeted for 2H25, and PREVAIL CVOT remains on track .
• Liquidity strengthened materially post December offering: cash, cash equivalents and marketable securities reached $834.2M at year-end, funding operations beyond PREVAIL readout and into potential U.S. launch, if approved .
• Financially, FY 2024 revenue rose to $45.6M (vs. $14.1M FY 2023) driven by milestones/reimbursements; full-year net loss widened to $241.6M on non‑cash fair value changes and higher SG&A for launch readiness .
• Q4 clinical catalysts drove the narrative more than P&L: TANDEM FDC achieved ~50% LDL-C reduction at day 84; BROADWAY showed a 33% LDL-C reduction and an observed 21% MACE reduction as an exploratory endpoint, supporting regulatory engagement and commercial planning .
• Wall Street consensus (S&P Global) was unavailable at time of retrieval; estimate comparisons are thus not provided at this time. Values retrieved from S&P Global were unavailable due to access limits.

What Went Well and What Went Wrong

What Went Well

• TANDEM met all co-primary endpoints; FDC LS mean LDL-C reduction of 48.6% vs placebo at day 84 with >70% of FDC patients achieving LDL-C <55 mg/dL; safety comparable to placebo .
• BROADWAY achieved primary endpoint (LS mean LDL-C reduction of 33% vs placebo at day 84) with favorable safety and observed 21% reduction in first 4‑point MACE at one year (exploratory) .
• Balance sheet strength: year‑end cash and marketable securities of $834.2M supports inventory build and commercial capability scaling for potential U.S./EU launches; management explicitly highlighted capital sufficiency beyond PREVAIL readout .

What Went Wrong

• Net loss expanded in FY 2024 to $241.6M, reflecting non‑cash fair value changes (earnout and warrants) and increased SG&A for launch readiness; operating loss was $176.3M .
• No earnings call transcript available for Q4, limiting visibility into Q&A nuances and near‑term opex guidance granularity (press release furnished, but transcript not found) .
• R&D still elevated given ongoing programs; while down YoY to $151.4M as trials completed/neared completion, absolute spend remains significant pending regulatory outcomes .

Financial Results

Notes: Q4 figures computed from FY less 9M; citations reflect source periods .

Segment breakdown: Not applicable (single asset clinical-stage model).

KPIs (clinical efficacy and safety, most recent quarter emphasis):

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “2024 was a transformative year… durable LDL-C lowering by obicetrapib… anticipated EMA submission in the second half [of 2025] by our partner Menarini.” — Michael Davidson, M.D., CEO .
• “We are increasing focus… launch readiness with plans to scale up and build inventory and commercial capabilities… capital to fund operations beyond the PREVAIL CVOT readout and commercial launch… pending regulatory approval.” — Michael Davidson, M.D., CEO .
• “We observed obicetrapib… to be clinically differentiated… lowering Lp(a) and small LDL-particles as well as potentially improving glycemic measures… difference in MACE at one year in BROADWAY supports our belief…” — Michael Davidson, M.D., CEO .
• “We observed clinically meaningful and statistically significant LDL-C lowering… once daily oral tablet of the fixed-dose combination of obicetrapib and ezetimibe.” — John Kastelein, M.D., Ph.D., CSO (TANDEM) .
• “The BROADWAY clinical trial highlights the transformative potential of obicetrapib… if approved, could help… reach LDL-C goals and significantly reduce risk of life-threatening cardiovascular events.” — Stephen Nicholls, M.B.B.S., Ph.D. .

Q&A Highlights

• No Q4 2024 earnings call transcript was available in the document set; therefore, Q&A themes and tone changes could not be assessed [ListDocuments: earnings-call-transcript returned none].

Estimates Context

• S&P Global consensus for Q4 2024 revenue and EPS was unavailable due to retrieval limits at the time of access; as a result, “vs. estimates” comparisons are not provided. Values retrieved from S&P Global were unavailable due to access limits.

Key Takeaways for Investors

• Clinical efficacy validated across pivotal Phase 3: TANDEM FDC ~50% LDL-C lowering; BROADWAY -33% LDL-C and observed 21% MACE reduction (exploratory), strengthening the regulatory/value proposition ahead of EMA filing in 2H25 .
• Safety profile consistently comparable to placebo with potential glycemic/renal advantages in BROADWAY, supporting broad real-world utility if approved .
• Liquidity inflection post December financing: $834.2M cash+marketable secures runway beyond PREVAIL CVOT readout and into commercial build, reducing financing overhang near term .
• Near-term catalysts include additional data dissemination (scientific meetings/journals), EMA submission, and ongoing PREVAIL CVOT progress, which are likely key stock drivers .
• FY revenue uplift reflects milestone accounting; underlying P&L pressure (operating and net losses) tied to development and commercialization investments—watch SG&A trajectory as launch readiness scales .
• IP moat reinforced (solid form patent to 2043), enhancing long-term defensibility against competitors in LDL‑lowering therapies .
• Absent consensus estimates, position sizing should focus on clinical/regulatory milestones and balance sheet strength rather than near-term earnings metrics; PREVAIL CVOT outcome remains the medium-term thesis fulcrum .