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CAMBRIDGE, Mass., July 31, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced financial results and updates for the second quarter ended June 30, 2025.
“With fewer than 40 days to our PDUFA goal date, our commercial team is prepared for the potential U.S. approval of PYRUKYND for thalassemia,” said Brian Goff, Chief Executive Officer, Agios. “In the second quarter, we made progress advancing our early- and mid-stage pipeline and remain on track to deliver topline results of the RISE UP Phase 3 trial for PYRUKYND in sickle cell disease by the end of the year. Collectively, our progress reflects our continued focus on delivering innovative medicines with the potential to transform the lives of those affected by rare diseases and deliver long-term shareholder value.”
Second Quarter 2025 and Recent Corporate Highlights
Commercial Performance – PYRUKYND® (mitapivat)
R&D Highlights
Second Quarter 2025 Financial Results
For the quarter ended June 30, 2025, net loss was $112.0 million dollars, compared to a net loss of $96.1 million dollars for the second quarter ended June 30, 2024.
Conference Call Information
Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the “Events & Presentations” tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.
About Agios: Fueled by Connections to Transform Rare Diseases
At Agios, our vision is to redefine the future of rare disease treatment. Fueled by connections, we build trusted partnerships with communities – collaborating to develop and deliver innovative medicines that have the potential to transform lives. With a foundation in hematology, we combine biological expertise with real-world insights to advance a growing pipeline of rare disease medicines that reflect the priorities of the people we serve. Agios is a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. To learn more, visit www.agios.com and follow us on LinkedIn and X.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of PYRUKYND® (mitapivat), tebapivat, AG-236 and AG-181; Agios’ plans, strategies and expectations for its preclinical, clinical and commercial advancement of its drug development, including PYRUKYND®, tebapivat, AG-236 and AG-181; Agios’ use of proceeds from the transaction with Royalty Pharma; potential U.S. net sales of vorasidenib and potential future royalty payments; Agios’ strategic vision and goals, including its key milestones for 2025; and the potential benefits of Agios’ strategic plans and focus. The words “anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” “vision,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. For example, there can be no guarantee that any product candidate Agios is developing will successfully commence or complete necessary preclinical and clinical development phases, or that development of any of Agios’ product candidates will successfully continue. There can be no guarantee that any positive developments in Agios’ business will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation: risks and uncertainties related to the impact of pandemics or other public health emergencies to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to establish and maintain key collaborations; uncertainty regarding any royalty payments related to the sale of its oncology business or any milestone or royalty payments related to its in-licensing of AG-236, and the uncertainty of the timing of any such payments; uncertainty of the results and effectiveness of the use of Agios’ cash and cash equivalents; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
(Unaudited) | ||||||||
June 30, 2025 | December 31, 2024 | |||||||
Cash, cash equivalents, and marketable securities | $ | 1,339,404 | $ | 1,532,031 | ||||
Accounts receivable, net | 4,986 | 4,109 | ||||||
Inventory | 30,848 | 27,616 | ||||||
Total assets | 1,471,237 | 1,663,199 | ||||||
Stockholders' equity | 1,369,555 | 1,540,956 |
Consolidated Statements of Operations Data | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Revenues: | |||||||||||||||
Product revenue, net | $ | 12,455 | $ | 8,615 | $ | 21,181 | $ | 16,804 | |||||||
Total revenue | 12,455 | 8,615 | 21,181 | 16,804 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of sales | $ | 1,702 | $ | 1,495 | $ | 2,787 | $ | 2,122 | |||||||
Research and development | 91,940 | 77,401 | 164,683 | 146,021 | |||||||||||
Selling, general and administrative | 45,869 | 35,536 | 87,396 | 66,550 | |||||||||||
Total operating expenses | 139,511 | 114,432 | 254,866 | 214,693 | |||||||||||
Loss from operations | (127,056 | ) | (105,817 | ) | (233,685 | ) | (197,889 | ) | |||||||
Interest income, net | 14,513 | 8,120 | 30,600 | 17,009 | |||||||||||
Other income, net | 523 | 1,579 | 1,776 | 3,213 | |||||||||||
Net loss | $ | (112,020 | ) | $ | (96,118 | ) | $ | (201,309 | ) | $ | (177,667 | ) | |||
Net loss per share - basic and diluted | $ | (1.93 | ) | $ | (1.69 | ) | $ | (3.49 | ) | $ | (3.14 | ) | |||
Weighted-average number of common shares used in computing net loss per share – basic and diluted | 57,932,576 | 56,802,546 | 57,697,193 | 56,593,011 |
Contacts:
Investor Contact
Morgan Sanford, VP, Investor Relations
Agios Pharmaceuticals
[email protected]
Media Contact
Eamonn Nolan, Senior Director, Corporate Communications
Agios Pharmaceuticals
[email protected]
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