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Agios Reports Fourth Quarter and Full Year 2019 Financial Results
Fourth Quarter TIBSOVO® Net Revenue of $19.6M and $59.9M for Full Year 2019; Full Year
2020 U.S. TIBSOVO® Net Revenue Expected to be Between $105-115 Million
New Clinical Data from Mitapivat in Thalassemia and Sickle Cell Disease to be Submitted for
Presentation at the European Hematology Association Annual Congress in June
Investigational New Drug Submission for AG-946, a Next Generation PKR Activator, Expected in Q1
CAMBRIDGE, Mass., February 13, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today reported business highlights and financial results for the fourth quarter and year ended December 31, 2019. In addition, Agios highlighted key 2020 corporate milestones and data presentations for its clinical development programs.
On the heels of a busy and productive 2019, Im more confident than ever in the strength of our team and our ability to make a meaningful impact on the lives of patients through great science, a deep pipeline and differentiated therapies, said Jackie Fouse, Ph.D., chief executive officer at Agios. In 2020, our clinical development team is focused on advancing our Phase 3 PK deficiency studies in order to submit a new drug application in 2021, finalizing our pivotal development plan for the PK activation program in thalassemia and establishing proof-of-concept in sickle cell disease. In addition, we are driving enrollment in several Phase 3 studies for our IDH inhibitors in both malignant hematology and solid tumors. Our commercial team is focused on achieving an ambitious revenue target for TIBSOVO® and increasing market development activities in preparation for a potential launch in PK deficiency.
ANTICIPATED 2020 KEY MILESTONES
Agios expects the following key milestones in 2020:
Deliver full-year U.S. revenue for TIBSOVO® of $105-115 million
Receive European Medicines Agency CHMP opinion for TIBSOVO® in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by year-end
Complete enrollment of the Phase 3 AGILE trial of TIBSOVO® in combination with azacitidine in adult patients with previously untreated IDH1 mutant AML by year-end
Complete enrollment of the relapsed or refractory myelodysplastic syndrome arm of the TIBSOVO® Phase 1 study of IDH1 mutant advanced hematologic malignancies by year-end
File supplemental new drug application (sNDA) for TIBSOVO® in previously treated IDH1 mutant cholangiocarcinoma by year-end
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, February 13, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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