FibroGen Inc. (NASDAQ:FGEN) has announced its Q3 2020 financial results with strong Roxadustat net sales in China of $22.7 million and also provided corporate updates.
FibroGen reports revenue of $44 million in Q3 2020
In Q3, the company reported total revenue of $44 million consisting of $22.7 million from Chinese nets sales of roxadustat and $20.7 million in development revenue. The company also recognized $2.3 million in sales revenue for bulk drug product and a $1.7 million net reduction in certain adjustments.
FibroGen amended its agreement with AstraZeneca in China in July 2020 with both parties aligned optimally to leverage roxadustat’s economic value with predictable profitability for FibroGen. Following the amendment, FibroGen managed to reverse co-promotion expenses of $84.4 million as a reduction to selling and administrative expenses during the quarter. At the end of the quarter, the company had cash and cash equivalents of $719.3 million. The company expects to end 2020 with cash and investments of between $770 million and $780 million.
Updates in roxadustat development
The company and its partners presented 42 abstracts at the ASN Kidney Week 2020 Reimagined conference. The presentation included two late-breaker poster presentation and ten oral presentations. The new analysis demonstrated roxadustat’s efficacy in patients with anaemia od chronic kidney diseases for both those on dialysis and not on dialysis. The presentations address roxadustat safety in relation to ophthalmological, hypertension and neoplasm effects. Currently, an NDA for roxadustat in treating anaemia of CKD in dialysis-dependent patients and non-dialysis dependent patients is under review with PDUFA action date set on December 20, 2020. There is also an MAA for roxadustat in treating adult CKD patients which the EMA is reviewing, and the Pharmaceutical and Medical Devices Agency is reviewing sNDA for roxadustat in Japan.
FibroGen initiated LELANTOS third phase study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy (DMD) during the quarter. Enrolment is also ongoing in the ZEPHYRUS phase 3 clinical study of pamrevlumab in idiopathic pulmonary fibrosis patients. Lapis Phase clinical study of pamrevlumab in locally advanced pancreatic cancer is ongoing.