On November 3, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported business highlights and financial results for the third quarter ended Sept. 30, 2021 (Press release, Agios Pharmaceuticals, NOV 3, 2021, View Source [SID1234594256]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the third quarter, we have continued our strong clinical and operational execution. Following our NDA and MAA filings for mitapivat for adults with PK deficiency, the team is laser-focused on launch preparations in this indication, as well as on initiating three pivotal trials across thalassemia and sickle cell disease by year-end," said Jackie Fouse, Ph.D., chief executive officer at Agios. "As we look ahead to the end of the year and to 2022, Agios is extremely well-positioned to enter our next phase of growth, with our first genetically defined disease commercial launch on the horizon, the expected initiation of three pivotal adult trials and two pediatric PK deficiency trials and a robust pipeline filled with optionality and possibility. We look forward to sharing more insights on our clinical and preclinical pipeline and our commercial launch efforts at our investor day in November."
THIRD QUARTER 2021 & RECENT HIGHLIGHTS
Received Priority Review designation for the new drug application of mitapivat in PK deficiency by the U.S. Food and Drug Administration (FDA), accelerating review time from 10 months to six months from the day of filing acceptance; Prescription Drug User Fee Act (PDUFA) action date set for Feb. 17, 2022.
Initiated first global trial sites for Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in not regularly transfused and regularly transfused adults with α- or β-thalassemia.
Continued start-up activities for the Phase 2/3 study of mitapivat in sickle cell disease. In collaboration with a global team of sickle cell disease patients and caregivers, developed study name – RISE UP – and unveiled it at the Sickle Cell Disease Association of America 49th Annual National Convention last month.
In Q3, repurchased approximately 5.3 million shares of Agios common stock at an average price of $47.94 per share. To date, the company has completed more than $800 million of the up to $1.2 billion of share repurchases authorized by the Board of Directors following the company’s sale of its oncology business to Servier, representing a reduction of just over 23% of our starting share count.
KEY UPCOMING MILESTONES
Host investor day on Nov. 17 to share updates on the company’s research and development pipeline, as well as provide additional insights into the commercial launch strategy and expectations for mitapivat in PK deficiency.
Initiate Phase 2/3 RISE UP study of mitapivat in sickle cell disease by year-end.
Data Presentations
Submitted the following select data for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, hosted Dec. 11-14:
Long-term efficacy data of mitapivat in adults with PK deficiency who participated in the Phase 3 ACTIVATE and ACTIVATE-T trials
Long-term efficacy and safety data of mitapivat in adults with thalassemia who do not receive regular transfusions
Efficacy, safety and translational data of mitapivat in sickle cell disease from ongoing collaborator-led studies
Phase 1 healthy volunteer study data of AG-946, the company’s novel PK activator
THIRD QUARTER 2021 FINANCIAL RESULTS
The financial results discussion compares Agios’ continuing operations. All periods have been adjusted to exclude discontinued operations related to the divested oncology business.
Research and Development (R&D) Expenses: R&D expenses for continuing operations were $64.0 million for the third quarter of 2021 compared to $51.9 million for the third quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase 3 studies of mitapivat in thalassemia and sickle cell disease, as well as disease education and engagement efforts for mitapivat in PK deficiency, thalassemia and sickle cell disease.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were $27.2 million for the third quarter of 2021 compared to $28.3 million for the third quarter of 2020.
Non-Operating Income: Non-operating income included approximately $2.0 million from TIBSOVO (ivosidenib) royalties for the third quarter of 2021.
Net Loss: Net loss was $88.8 million for the third quarter of 2021 compared to a net loss of $99.0 million for the third quarter of 2020.
Cash Position and Guidance: Cash, cash equivalents and marketable securities as of Sept. 30, 2021, were $1.4 billion compared to $722.4 million as of Sept. 30, 2020. The company expects that its cash, cash equivalents and marketable securities will enable the company to execute its operating plan through major catalysts and to cash-flow positivity without the need to raise additional equity.
CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2021 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 5748074. 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.
November 17 Investor Event Webcast Information
Agios will host an investor webcast on November 17, 2021 at 2:00 p.m. ET to discuss the company’s research and development pipeline, as well as provide additional insights into the commercial launch strategy and expectations for mitapivat in PK deficiency. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of Agios’ website at www.agios.com. The archived webcast will be available on Agios’ website beginning approximately two hours after the event.