Khalil Fenina

Khalil Fenina asked about the expected cadence of the 1,000 patient start forms projected for the next nine to twelve months, inquiring if a bolus is anticipated early in the year or if seasonal adjustments in Q1 might affect the timing.

Answer

Anish Bhatnagar, Chairman and CEO, stated that the 1,000 start forms should be considered over the nine to twelve months, not necessarily quarter-to-quarter, without an expected bolus. Meredith Manning, Chief Commercial Officer, reiterated the goal to sustain momentum by focusing on KOLs, community settings, and caregiver activation.

Khalil Fenina asked about the expected cadence of the 1,000 new patient start forms projected for the next 9 to 12 months, inquiring if a bolus is anticipated early in the year or if seasonal adjustments in Q1 might affect the distribution.

Answer

Anish Bhatnagar, Chairman and CEO, stated that the 1,000 start forms should be considered over the 9-12 month period, not necessarily quarter-to-quarter, without an expected bolus. Meredith Manning, Chief Commercial Officer, added that the company is focusing on broadening experience with KOLs, community settings, and activating caregivers to sustain momentum.

Khalil Fenina, on behalf of Paul Choi, asked about the company's capital deployment plans for the remainder of the year, given its strong cash position and proximity to operational breakeven.

Answer

CEO Dr. Matthew Klein reiterated that the company's strong cash position was built without assuming European Translarna revenue, making any ongoing sales upside. He stated the capital is sufficient to reach cash flow breakeven without needing to raise additional funds and also allows for strategic business development to augment the portfolio.

Inquired about the proportion of patients who will receive PET imaging in the upcoming Phase 2 trial of FG-3246 and sought clarification on the company's revenue guidance for Roxadustat, specifically the discrepancy between China sales growth and overall net sales guidance and the role of deferred revenue.

Answer

The majority, but not all, of the 75 patients in the Phase 2 trial will be imaged with the PET agent due to the timing of the IND filing. The Q4 revenue guidance accounts for a potential accounting adjustment (increased deferred revenue) if the CIA indication is approved in Q4, which would lower recognized revenue for the period. The $12.5 million in Q3 was a release from deferred revenue, increasing Q3's reported revenue.

Khalil Fenina of Goldman Sachs asked if all 75 patients in the upcoming FG-3246 Phase 2 monotherapy trial would be imaged with the FG-3180 PET agent. He also sought clarification on FibroGen's Q4 revenue guidance for roxadustat, questioning the implied sequential decline and the nature of a $12.5 million deferred revenue adjustment.

Answer

CEO Thane Wettig responded that the majority, but not all, of the 75 patients would receive the PET imaging agent due to staggered IND filings for the drug and the agent. CFO Juan Graham explained the revenue guidance accounts for a potential accounting adjustment; if the CIA indication is approved in Q4, accounting rules would require deferring more revenue, thus lowering the recognized figure for the quarter. He confirmed the $12.5 million was a release from deferred revenue, which increased Q3's reported revenue.