Accelerated Adoption of Guardant360 Tissue ASP Achieving 2028 Target Three Years Early
Guardant360 Tissue ASP reached approximately $2,000 in Q2, surpassing the 2028 target three years ahead of schedule.
Major upgrade in April expanded the panel to include RNA and methylome analysis, with 40% fewer slides than industry norm, serving as a key differentiator.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
ANI achieved all-time highs in net revenue, adjusted non-GAAP EBITDA, and EPS in Q2 2025, driven by strong growth across Rare Disease and Generics units.
The company highlighted broad momentum, with Rare Disease demand accelerating, especially for Cortrophin Gel, and positive results in their retina franchise.
Management emphasized that the quarter's performance was driven by underlying demand rather than seasonality or one-time benefits, with new patient starts more than doubling year-over-year.
Adjusted EBITDA was $10.7 million, down 2% from prior year, impacted by Pathline acquisition ramp; excluding Pathline, adjusted EBITDA grew 13%.
Adjusted gross profit improved by $4.6 million or 6% over prior year.
Cash flow from operations was positive $20 million, up 44% year-over-year, with cash and marketable securities ending at $164 million.
Clinical revenue grew 16% year-over-year with organic clinical revenue up 13%, driven by a 10% increase in test volumes and a 3% increase in average unit price (AUP).
NeoGenomics reported Q2 2025 revenue of $181 million, representing 10% year-over-year growth but slightly below guidance.
NGS testing accounted for 32% of total clinical revenue and grew 23%, slightly below the 25% target but above market growth rates.
Nonclinical revenue declined 26% year-over-year due to weakness in pharma and biotech customer demand.
The company retired $201 million of convertible notes in Q2, significantly reducing debt.
Strategic Focus on Phase III Readouts and Clinical Progress
The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.