FDA Approval of PYLARIFY TRUVU
FDA approved PYLARIFY TRUVU on March 6, 2026. The new formulation offers larger batch sizes and improved stability at higher radioactive concentrations, enabling broader geographic reach and supply flexibility. Management estimates >70% of current PYLARIFY supply is produced at PMF sites equipped to realize TRUVU advantages.
Total Revenue and Adjusted Growth
First-quarter revenue was $377.3 million, up 1.2% year-over-year and up 8.6% when adjusted to exclude $25.2 million of divested spec revenues from the prior-year period.
PYLARIFY Volume Momentum
PYLARIFY U.S. volume increased approximately 5.8% year-over-year with sequentially stable net ASP and volume despite competitive activity, supporting market leadership and a planned transition to PYLARIFY TRUVU.
NEUROCEQ Rapid Growth and Footprint Expansion
NEUROCEQ generated $35.4 million in Q1 revenue, a 14.3% increase compared to Q4 2025. The PMS (manufacturing) footprint expanded to 22 sites, supporting deeper penetration and higher supply availability.
DEFINITY Solid Performance
DEFINITY delivered $84.6 million in Q1 revenue, representing ~6.8% year-over-year growth. The product maintains >80% market share and steady utilization across care sites.
Strength in Strategic Partnerships / Pharma Solutions
Strategic partnerships and other revenue was $16.3 million, up 52.1% year-over-year, driven by Pharma Solutions strength and addition of Evergreen CDMO; MK-6240 represented over half of this category's revenue.
Strong Cash Generation and Balance Sheet Flexibility
Operating cash flow was $125.1 million (vs. $107.6M prior year). Capital expenditures were $3.2 million; free cash flow was $121.9 million, up $23.1 million year-over-year. Cash and equivalents were $498.6 million, with $200 million remaining on buyback authorization and access to a $750 million undrawn revolver.
Maintained Full-Year Guidance and Outlook for 2027 Acceleration
Company reaffirmed FY2026 revenue guidance of $1.4B–$1.45B and adjusted EPS guidance of $5.00–$5.25, and reiterated expectation of growth acceleration beginning in 2027 driven by commercial execution and regulatory milestones.