Release Date: May 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- FibroGen Inc (FGEN, Financial) reported strong financial performance with a 55% year-over-year increase in total revenue for Q1 2024, driven by net product revenue in China and one-time drug product revenue.
- Pamrevlumab, an anti-CTGF human monoclonal antibody, is progressing in pivotal Phase III studies for pancreatic cancer, with potential to address significant unmet needs in this area.
- Roxadustat, approved in over 40 countries, continues to generate significant revenue and positive cash flow, particularly in China where it saw a 24% increase in net sales.
- FibroGen Inc (FGEN) has regained rights to roxadustat in the U.S. and other regions, providing opportunities for new partnerships and expanded indications.
- The company maintains a strong cash position with $214.7 million, expected to fund operations into 2026, supporting ongoing clinical trials and product development.
Negative Points
- Despite strong growth, the company recorded a net loss of $32.9 million for Q1 2024, indicating ongoing challenges in achieving profitability.
- The pace of event accrual in the LAPIS Phase III study has decreased, potentially delaying the expected data readout for pamrevlumab in pancreatic cancer.
- The introduction of generics in China poses a risk to roxadustat's market share and revenue, despite current strong performance.
- FibroGen Inc (FGEN) faces regulatory uncertainties, particularly concerning the approval and reimbursement timelines for roxadustat's new indications in China.
- Operational and financial risks are heightened by the need for strategic partnerships to maximize the potential of regained rights for roxadustat in various regions.
Q & A Highlights
Q: Could you educate us on why there is a slowing of the event rates as you wrap up the LAPIS study?
A: Thane Wettig, CEO & Director of FibroGen, explained that the slowing event rate is a common occurrence in event-driven oncology trials. As the trial progresses, fewer patients remain to accrue the necessary overall survival (OS) events, leading to a slowdown. The company continues to monitor the number of OS events weekly and expects to reach the prespecified number in Q3, allowing them to lock the database and release top-line results.
Q: What's driving the uptick in roxadustat's market value share in China?
A: Christine L. Chung, SVP of China Operations, attributed the increase in roxadustat's market value share to a recent price cut and the introduction of a new HIF entrant, enarodustat, which may have boosted the class. The strong sales force and installed base of prescribers and patients have also contributed to the momentum.
Q: As you think about the enzalutamide plus FG-3246 combination, what are KOLs looking for in terms of clinical benefit?
A: Deyaa Adib, Senior VP & Chief Medical Officer, mentioned that the trial aims to prove that patients previously exposed to second-generation ARSIs overexpress CD46, potentially sensitizing them to FG-3246 treatment. The study is still in the dose escalation phase, and it's too early to set a benchmark for success. The focus is on radiographic progression-free survival as a potential registration path.
Q: Could you explain the reason for the Phase II dose optimization study for FG-3246 planned for the second half of this year?
A: Thane Wettig stated that the study aims to optimize the dose for Phase III, ensuring maximum clinical benefit with minimal risk. This approach aligns with FDA requirements and will include treating patients with the PET46 biomarker to assess the correlation of CD46 expression and response to the ADC.
Q: What is the updated timing for the approval of the chemotherapy-induced anemia (CIA) indication for Evrenzo in China?
A: Christine L. Chung confirmed that the projected approval timeframe is the second half of 2024. If approved by June 30, 2024, Evrenzo could qualify for inclusion in the NRDL starting January 1, 2025. The team is working closely with the CDE on the review, aiming to achieve this goal.
Q: Is there potential to accelerate the timeline for the Phase II dose optimization of FG-3246 based on insights from the monotherapy portion?
A: Thane Wettig noted that while it's premature to discuss specific timelines, the goal is to start the trial as soon as possible after FDA discussions. The trial is expected to enroll rapidly, and the company plans to treat all patients in this phase with the PET46 biomarker for further analysis.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
