FibroGen (FGEN) 6 Aug 24 2024 Q2 Earnings call transcript
In the second quarter of 2024, FibroGen held a significant earnings call, highlighting a mix of challenges and opportunities for the biotech company. The call, led by CEO Thane Wettig, provided insights into FibroGen's recent developments and strategic shifts.
Strategic Pivots and Challenges
FibroGen faced a setback with its pamrevlumab clinical trials in pancreatic cancer, which did not meet the primary endpoint of overall survival. As a result, the company has announced a significant cost reduction plan, including a 75% reduction in U.S. headcount. Despite this setback, FibroGen remains optimistic about its pipeline, particularly its first-in-class antibody drug conjugate (ADC), FG-3246, targeting CD46 for metastatic castration-resistant prostate cancer.
CD46 Targeted ADC, FG-3246, and PET46 Imaging Agent
FG-3246 is a potent ADC with an associated CD46 targeted PET imaging agent, PET46. The combination of FG-3246 and PET46 is expected to achieve a differentiated clinical profile in prostate cancer treatment paradigms. The use of PET46 as a patient selection biomarker will allow for better enrichment of patients, potentially enhancing the clinical benefit of FG-3246. The company anticipates two catalysts for FG-3246 in 2025, including top-line data from the Phase II portion of the combination trial and the initiation of the Phase II monotherapy trial.
Strong China Performance and Roxadustat
Roxadustat, a key asset for FibroGen, continues to perform well in China, generating significant net revenue and positive cash flow. The strong roxadustat performance in China has led to an increase in FibroGen's full-year net product revenue guidance for 2024. The company is also expecting an approval decision from the Chinese authorities in the second half of 2024 for chemotherapy-induced anemia, which could further boost roxadustat's revenue.
Partnering Opportunities and Financial Outlook
FibroGen is actively exploring partnering opportunities for its remaining pipeline, including the immuno-oncology programs FG-3165 and FG-3175. The company has made significant advancements in these programs, including optimizing their affinity and receiving IND clearance for FG-3165. FibroGen also expects to file the IND for PET46 in the next quarter and initiate a Phase II dose optimization study in mCRPC in the first quarter of 2025.
Conclusion
Despite the challenges faced with the pamrevlumab trials, FibroGen remains optimistic about its future. The company's strategic shifts, particularly the focus on FG-3246 and roxadustat, position FibroGen for continued growth and potential shareholder value creation. With a strong pipeline, a robust China business, and a focus on partnerships, FibroGen is well-positioned to navigate the complex biotech landscape and drive innovation in cancer treatment.