Agios Reports Business Highlights and Second Quarter 2022 Financial Results
– Generated $3.1 Million in Net U.S. Revenue for First Full Quarter of PYRUKYND® (mitapivat) Sales –
– Brian Goff to Become Chief Executive Officer at Agios on August 8, 2022, Leveraging 30+ Years of Biopharma Experience, Including Significant Expertise in Rare Disease and Hematology; Current CEO Jackie Fouse to Become Chair of the Board –
– Actively Enrolling Patients in Five PYRUKYND® Pivotal Studies Across Thalassemia, Sickle Cell Disease and Pediatric Pyruvate Kinase (PK) Deficiency –
– $1.1 Billion of Cash, Cash Equivalents and Marketable Securities as of June 30, 2022 –
CAMBRIDGE, Mass., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today reported business highlights and financial results for the second quarter ended June 30, 2022.
“As we look ahead to the next chapter for the company, Agios is operating from a position of strength. We are executing our commercial launch of PYRUKYND®, the first therapy for a rare, debilitating, lifelong blood disorder; we also have five pivotal trials underway, multiple early-stage studies planned or ongoing, a promising preclinical pipeline and a strong balance sheet providing optionality for the future growth of the business,” said Jackie Fouse, Ph.D., chief executive officer at Agios. “As I reflect on my legacy as CEO of Agios, I am proud of the bold and strategic decisions we have made to maximize and accelerate our impact for people with genetically defined diseases. I am tremendously grateful to the Agios team for their unwavering resiliency in the face of unprecedented challenges and heartfelt dedication to patients and each other. I look forward to my new role at Agios as board chair and to supporting Brian as he leverages his expertise to expand Agios’ genetically defined disease capabilities, foster the company’s differentiated culture and drive our next phase of impact.”
Second Quarter 2022 & Recent Highlights
Key Upcoming Milestones & Priorities
Agios expects to execute on the following key milestones and priorities in 2022:
Second Quarter 2022 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.
Revenue: Net U.S. product revenue from sales of PYRUKYND® for the second quarter of 2022 was $3.1 million. This revenue reflects the first full quarter of PYRUKYND® launch, following FDA approval on February 17, 2022. In addition, Agios recognized revenue of $2.5 million dollars in the second quarter of 2022 as an up-front payment associated with the licensing of intellectual property for the company’s Friedreich’s Ataxia preclinical program.
Cost of Sales: Cost of sales for the second quarter of 2022 was $0.4 million.
Non-Operating Income: Non-operating income included approximately $2.7 million from TIBSOVO® (ivosidenib) royalties for the second quarter of 2022.
Research and Development (R&D) Expenses: R&D expenses were $74.5 million for the second quarter of 2022 compared to $62.0 million for the second quarter of 2021. The year-over-year increase in R&D was driven primarily by increased headcount and workforce-related expenses, planned increased activity associated with the PAH preclinical program, start-up costs for the AG-946 Phase 2a MDS study, increased spend for the AG-946 Phase 1 trial, and start-up costs for the PYRUKYND pivotal studies in sickle cell disease and pediatric PK deficiency.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $28.3 million for the second quarter of 2022 compared to $29.2 million for the second quarter of 2021. The year-over-year decrease in SG&A expenses was primarily attributable to the completion of the reimbursable transition services Agios provided to Servier, which concluded in the first quarter of 2022, related to the sale of the oncology business.
Net Loss from Continuing Operations: Net loss from continuing operations was $91.8 million for the second quarter of 2022 compared to a net loss of $82.8 million for the second quarter of 2021.
Cash Position and Guidance: Cash, cash equivalents and marketable securities as of June 30, 2022, were $1.1 billion compared to $1.7 billion as of June 30, 2021. The year-over-year decrease is attributable to operating expenses and 5.7 million shares of common stock that the company repurchased for $273.4 million during the third and fourth quarters of 2021. Agios 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
Cautionary Note Regarding Forward-Looking Statements