Q1 2026 Revenue & Guidance
Reported total revenue of $44.8M and net product revenue of $42.0M for Q1 2026. Company raised FY2026 net NERLYNX product revenue guidance to $202M–$206M (up from prior $194M–$198M) and raised FY net income guidance to $16M–$19M (prior $10M–$13M). Q2 2026 product revenue guidance is $50M–$52M with Q2 net income expected $2M–$4M.
Commercial Demand & Engagement Improvements
New prescriptions (NRx) increased ~25% quarter-over-quarter and ~11% year-over-year; enrollments rose ~10% Q/Q and ~1% Y/Y. Commercial call activity increased 44% year-over-year and 14% quarter-over-quarter, and overall demand increased ~7% year-over-year.
Strong Global Execution & Market Expansion
Continued geographic expansion with recent launch of NERLYNX in Thailand (extended adjuvant). Specialty distributor channel showing strong year-over-year growth (~28% Y/Y) supporting broader adoption.
Improved Balance Sheet / Debt Retirement
Company is debt-free after final loan payment; cash, cash equivalents and marketable securities totaled approximately $101.5M at March 31, 2026 (up from $97.5M at year-end 2025). Q1 cash burn ~ $4M; accounts receivable $26.3M and ~3 weeks distribution inventory.
Promising Alisertib Biomarker-Driven Signals — ALISCA-Lung1
Interim data show dose-dependent efficacy and biomarker signal: 50 mg arm (n=52) PR 11.5% and median PFS 1.7 months; early 60 mg arm (initial 15 pts) PR 6.7% with median PFS 4.2 months. Patients with higher c-Myc H-score (101–300) showed median PFS 4.17 vs 1.68 months for H-score 0–100, suggesting higher activity in c-Myc–driven tumors.
Promising Alisertib Biomarker-Driven Signals — ALISCA-Breast1
Interim breast combo data (n=164) indicate activity in biomarker-defined subgroups: median PFS by dose — 30 mg 2.04 months, 40 mg 5.45 months, 50 mg 5.59 months. c-Myc copy number >2 median PFS 7.29 vs 2.0 for =2. ESR1-mutated and PIK3CA wild-type subgroups show encouraging PFS (some cohorts not yet reached). Company plans to expand enrollment in PIK3CA wild-type/ESR1-mutant cohorts in H2 2026.
Safety Improvements & Trial Design Adjustments
ALISCA-Lung1 mandated prophylactic G-CSF and shows lower Grade ≥3 neutropenia versus historical controls (e.g., 13.5% at 50 mg and 11.1% at 60 mg). Company is escalating dose to 70 mg and planning ALISCA-Lung2 (alisertib + paclitaxel with mandatory G-CSF) in H2 2026.