On November 5, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the third quarter ended September 30, 2020 (Press release, Agios Pharmaceuticals, NOV 5, 2020, View Source [SID1234570110]).
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"In the third quarter, we made significant strides toward executing against our key 2020 priorities and getting our medicines to patients who need them," said Jackie Fouse, Ph.D., chief executive officer at Agios. "Most notably, we generated mature overall survival data from our Phase 3 ClarIDHy study of TIBSOVO in previously treated cholangiocarcinoma, prepared for topline data readouts from our two global Phase 3 studies of mitapivat in pyruvate kinase deficiency and advanced our pivotal plans for mitapivat in thalassemia and sickle cell disease. We look forward to building on these achievements with a catalyst-rich fourth quarter and 2021."
THIRD QUARTER 2020 & RECENT HIGHLIGHTS
TIBSOVO (ivosidenib tablets) net sales of $31.7 million, an increase of 15% from the second quarter of 2020.
Reported topline mature overall survival results from ClarIDHy Phase 3 study of TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma patients; submitted final data for presentation at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI).
Withdrew European Marketing Authorization Application (MAA) for TIBSOVO in IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) as a result of feedback from European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Initiated Phase 1 healthy volunteers study of AG-946, a next-generation, orally available, small molecule activator of the metabolic enzyme pyruvate kinase-R (PKR).
Appointed Jonathan Biller as chief financial officer, head of legal and corporate affairs.
KEY UPCOMING MILESTONES
Rare Genetic Diseases
Report topline data from ACTIVATE, the company’s global pivotal trial for mitapivat in adults with pyruvate kinase (PK) deficiency who do not receive regular transfusions, by the end of 2020.
Report topline data from ACTIVATE-T, the company’s global pivotal trial for mitapivat in adults with pyruvate kinase (PK) deficiency who receive regular transfusions, in Q1 2021.
Finalize pivotal development plan for mitapivat in thalassemia, including both α-and β-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, by the end of 2020.
Finalize pivotal development plan for mitapivat in sickle cell disease in the first half of 2021.
Hematologic Malignancies and Solid Tumors
Deliver full-year 2020 U.S. revenue for TIBSOVO of $113-115 million; the company had previously provided guidance of $105-115 million.
Submit a supplemental new drug application for TIBSOVO in previously treated cholangiocarcinoma in Q1 2021.
Research
Achieve at least one new development candidate by year-end 2020.
UPCOMING INVESTOR EVENTS
November 19, 2020: Agios will host a webinar focused on its pyruvate kinase-R (PKR) activation clinical programs, including Agios’ leadership in elucidating the PKR activation mechanism, the commercial opportunity for each program and the company’s preparations for its first potential launch in a rare genetic disease, expected in 2022.
December 8, 2020: Agios will host a webinar to share updated data from the Phase 1 trial of mitapivat in sickle cell disease, which is being conducted in collaboration with the National Institutes of Health (NIH), as well as an overview of the company’s Phase 3 development plans for mitapivat in patients with thalassemia.
THIRD QUARTER 2020 FINANCIAL RESULTS
Revenue: Total revenue for the third quarter of 2020 was $34.7 million, which includes $31.7 million of net product revenue from sales of TIBSOVO, $2.3 million in collaboration revenue and $0.7 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene, now a wholly owned subsidiary of Bristol Myers Squibb. This compares to revenue of $26.0 million for the third quarter of 2019. Total revenue increased 33% from the same period last year, driven by an 82% increase in TIBSOVO net product revenue and offset by a decrease in collaboration revenue due to completion of the research and development services performance obligation with Celgene in the second quarter, as well as an adjustment in sales reserves taken in the third quarter by Bristol Myers Squibb.
Cost of Sales: Cost of sales were $0.6 million for the third quarter of 2020 compared to $0.4 million for the third quarter of 2019.
Research and Development (R&D) Expenses: R&D expenses were $89.6 million for the third quarter of 2020 compared to $101.7 million for the third quarter of 2019. The decrease in R&D expense was primarily attributable to a decrease in TIBSOVO clinical development costs, including winding down the ClarIDHy Phase 3 study.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $34.8 million for the third quarter of 2020 compared to $33.0 million for the third quarter of 2019. The increase in SG&A expense was primarily attributable to increased workforce expenses, offset by a decrease in external spending due to COVID-19 and cost savings initiatives.
Net Loss: Net loss was $99.0 million for the third quarter of 2020 compared to $106.2 million for the third quarter of 2019.
Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2020 were $722.4 million, compared to $540.5 million as of September 30, 2019. The company expects that its cash, cash equivalents and marketable securities as of September 30, 2020, together with anticipated product revenue, anticipated interest income and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements to the end of 2022.
CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss its third quarter 2020 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 7578909. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.
About the Agios/Celgene Collaboration
In 2010, Agios and Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, entered into a collaboration agreement focused on cancer metabolism. Under the terms of the agreement, Celgene has worldwide development and commercialization rights for IDHIFA (enasidenib). Celgene and Agios are currently co-commercializing IDHIFA in the U.S., and Agios continues to conduct certain clinical development activities within the IDHIFA development program. Agios is eligible to receive a $25 million payment upon achievement of a specified ex-U.S. commercial milestone event, as well as reimbursement for costs incurred for its co-commercialization efforts and development activities.