NASDAQ$NUVL

Nuvalent Inc · Q4 2024 earnings

Q4 2024 earnings · · Before market open · Investor relations

Briefing

Pipeline and business progress outlined, key anticipated milestones reiterated, and financial results reported for the fourth quarter and full year 2024.

Nuvalent reported its fourth quarter and full year 2024 financial results, highlighting pipeline advancements, the reiteration of key milestones, and the implementation of global Expanded Access Programs for zidesamtinib and neladalkib.

  • Pivotal data is expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations.
  • The first NDA submission is planned for mid-year 2025, targeting potential first approval in 2026 for zidesamtinib in the TKI pre-treated ROS1-positive NSCLC population.
  • Development strategies are in place for TKI-naïve populations, including the planned initiation of the ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in the first half of 2025.
  • Global Expanded Access Programs have been implemented for zidesamtinib and neladalkib, aligning with the goal of prioritizing patient access.

Headline financials

EPS (adj)

-$1.05

Previous: -$0.62-69.4%
Net Income

-$74.8M

Previous: -$38.3M-95.2%
Operating Income

-$86.3M

Previous: -$46.4M-85.8%

Revenue & EPS history

Nuvalent · Revenue · Quarterly

$6M

Q3 2025

Forward guidance

Nuvalent anticipates a steady cadence of milestones across its pipeline this year, supported by a strong balance sheet and a dedicated team.

Tailwinds

  • Pivotal data expected in 2025 for TKI pre-treated ROS1-positive NSCLC.
  • Pivotal data expected in 2025 for TKI pre-treated ALK-positive NSCLC.
  • First NDA submission planned for mid-year 2025 for zidesamtinib.
  • Potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC.
  • ALKAZAR Phase 3 trial initiation planned for H1 2025 for front-line ALK-positive NSCLC.

Historical earnings impact

How earnings announcements have historically affected this stock's price.

Avg. return before/after earnings

Based on 17 quarterly earnings reports · overlaid with Q4 2024

Historical avgQ4 2024

-0.0%

Avg return

Earnings day

-0.8%

Avg return

5 days after

-7.7%

Avg return

30 days after

38%

8 / 21 earnings

Positive

+14.6%

Q4 2021

Best reaction

-5.0%

Q3 2025

Worst reaction

Earnings price reactions
QuarterReport dateReaction (Day 0)+5 days+30 days
Q4 2025-0.5%-4.1%-7.5%
Q3 2025-5.0%-11.6%+6.2%
Q1 2025+3.2%+3.7%+10.2%
Q4 2024-2.8%-7.0%-5.2%
Q3 2024-4.3%-8.0%-8.0%
Q1 2024-3.1%+0.7%+17.2%
Q4 2023-1.4%+0.6%-13.3%
Q3 2023+3.7%+5.0%+38.8%
Q2 2023-1.1%-3.1%+9.2%
Q1 2023-2.5%-1.1%+3.5%
Q4 2022+8.3%+4.7%+0.9%
Q3 2022+1.0%+2.9%-2.1%
Q2 2022+4.5%+9.3%+13.1%
Q1 2022-0.7%+7.3%+16.1%
Q4 2021+14.6%+20.2%-8.1%
Q3 2020+1.3%-14.7%-2.4%
Q3 2021+1.3%-10.4%-20.1%
Q2 2020-4.3%-2.9%-52.6%
Q1 2021-4.3%-2.9%-52.6%
Q2 2021-4.3%-2.9%-52.6%
Q4 2020-4.3%-2.9%-52.6%
Q1 2020

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