Senseonics transitioned from a 6-month to a 12-month sensor cycle, significantly impacting reorder volume in Q2 and Q3 2025.
Nearly all sensors sold in Q2 and Q3 are for new patient starts, with reorders expected to contribute more in Q4 as the first 365-day users reach their next insertion.
Management expects reorders to bolster sales in Q4, aligning with the first anniversary of the Eversense 365 launch.
The shift to a 12-month cycle aims to improve patient retention and long-term user engagement, with higher retention rates anticipated for the 365 version.
The company is actively supporting this transition with increased marketing and sales efforts to accelerate adoption and reorder frequency.
U.S. Launch Growth and Real-World Data for Amtagvi
Iovance has surpassed 100 patients treated in a single quarter for the first time with Amtagvi, indicating strong adoption.
Real-world data shows a nearly 49% response rate overall and approximately 61% in patients treated in earlier lines, reinforcing the therapy's durability.
The company plans to onboard large community practices in Q4, targeting earlier treatment settings and potentially higher response rates.
Demand is driven by increased field activities, new centers, and strategic distribution channels like specialty pharmacies, expanding access in community settings.
Management emphasizes the potential for peak U.S. sales of $1 billion or more, with international markets offering additional growth opportunities.
The focus on earlier treatment settings and community oncology networks aims to position Amtagvi as a preferred option for appropriate patients.
Expansion of ATTR-CM Study and Its Strategic Implications
The expansion does not impact the previously projected enrollment timeline or cash runway, demonstrating operational efficiency and financial prudence.
The increased enrollment is expected to provide more definitive evidence of nex-z’s efficacy both as a monotherapy and in combination with stabilizers, which is a key market differentiator.
Management emphasizes that this strategic move aligns with their goal of multiple prospective launches by 2030, reinforcing their long-term market strategy.
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.
Dafinchi