Agios Pharmaceuticals (NASDAQ:AGIO) Posts Earnings Results, Beats Estimates By $0.15 EPS

Key Points

• Agios reported a quarterly loss of $1.09 per share, $0.15 better than estimates, while revenue of $55.39 million topped forecasts of $51.65 million.
• Revenue reached a record, more than quadrupling from a year earlier, driven by AQVESME’s thalassemia launch; U.S. revenue rose 20% sequentially.
• The FDA’s request for additional information extended the review of mitapivat for sickle cell disease by three months, shifting the decision target to February 1, 2027.

Agios Pharmaceuticals (NASDAQ:AGIO - Get Free Report) posted its earnings results on Thursday. The biopharmaceutical company reported ($1.09) earnings per share for the quarter, beating the consensus estimate of ($1.24) by $0.15, FiscalAI reports. Agios Pharmaceuticals had a negative net margin of 418.24% and a negative return on equity of 35.67%. The business had revenue of $55.39 million for the quarter, compared to analyst estimates of $51.65 million.

Here are the key takeaways from Agios Pharmaceuticals' conference call:

• Agios reported record third-quarter revenue of $55.4 million, more than four times the year-ago quarter, with $48.7 million from U.S. sales. The company attributed growth to AQVESME’s thalassemia launch and said U.S. revenue rose 20% sequentially.
• The FDA’s request for additional information on whether a REMS is needed for mitapivat in sickle cell disease extended the review by three months, moving the PDUFA goal date to February 1, 2027. Agios said it is discussing labeling and potential REMS elements with the agency and remains launch-ready.
• AQVESME had 619 completed start forms since launch—about 15% of Agios’s roughly 4,000-patient target population—with another 48 in process. The company reported approximately 75% of patients remained on therapy at six months and said demand is broadening to community practices and non-transfusion-dependent patients.
• Agios highlighted upcoming sickle cell data on sustained hemoglobin responses and post-hoc kidney and cardiac measures, while noting the organ findings are exploratory. It also expects to present AG-236 healthy-volunteer data at ASH, including effects lasting through six months, and plans to begin its PV phase II/III program by year-end.
• Agios ended the quarter with $907 million in cash and expects 2026 operating expenses to remain approximately flat year over year, excluding specified one-time items. It plans to reduce R&D headcount by more than 35% during 2026, with savings expected in 2027, and is targeting non-GAAP profitability in 2028.

Agios Pharmaceuticals Stock Down 9.9%

NASDAQ:AGIO traded down $3.11 during trading hours on Thursday, reaching $28.27. 2,546,104 shares of the stock were exchanged, compared to its average volume of 1,074,140. The stock has a market capitalization of $1.69 billion, a P/E ratio of -4.03 and a beta of 0.66. The firm has a 50 day simple moving average of $33.48 and a 200-day simple moving average of $31.74. Agios Pharmaceuticals has a 52 week low of $22.24 and a 52 week high of $46.00.

Analyst Upgrades and Downgrades

AGIO has been the subject of several analyst reports. Citigroup upped their target price on Agios Pharmaceuticals from $46.00 to $52.00 and gave the stock a "buy" rating in a research report on Friday, July 31st. Truist Financial cut their price objective on shares of Agios Pharmaceuticals from $39.00 to $37.00 and set a "buy" rating on the stock in a report on Wednesday, October 7th. HC Wainwright assumed coverage on shares of Agios Pharmaceuticals in a research report on Thursday, October 29th. They issued a "buy" rating and a $55.00 price objective for the company. TD Cowen upgraded Agios Pharmaceuticals to a "strong-buy" rating in a research note on Monday, August 24th. Finally, Weiss Ratings reissued a "sell (d)" rating on shares of Agios Pharmaceuticals in a report on Monday, September 21st. One equities research analyst has rated the stock with a Strong Buy rating, five have given a Buy rating, three have assigned a Hold rating and one has assigned a Sell rating to the stock. According to MarketBeat.com, the company presently has a consensus rating of "Moderate Buy" and an average price target of $41.50.

Agios Pharmaceuticals News Summary

Here are the key news stories impacting Agios Pharmaceuticals this week:

• Positive Sentiment: Agios reported a third-quarter loss of $1.09 per share, narrower than analysts’ estimates, while revenue of $55.39 million exceeded expectations of $51.65 million. The per-share loss also improved from $1.78 a year earlier. Read More.
• Positive Sentiment: Mitapivat revenue reportedly increased more than fourfold, a sign of commercial momentum for the drug. The FDA is expected to decide on mitapivat for sickle cell disease in February 2027, giving investors a defined upcoming catalyst. Read More.
• Neutral Sentiment: Agios plans to present new clinical data on mitapivat in sickle cell disease and AG-236 in polycythemia vera at ASH 2026. The presentations may provide updates on the pipeline, though their investment impact depends on the data. Read More.
• Negative Sentiment: Agios aims to eliminate more than 100 R&D roles, a substantial workforce reduction that may signal tighter spending and prioritization but could also raise concerns about execution and resources for its pipeline. The company remains loss-making despite beating quarterly estimates. Read More.

Insider Transactions at Agios Pharmaceuticals

In related news, insider Sarah Gheuens sold 7,866 shares of the firm's stock in a transaction on Monday, October 26th. The stock was sold at an average price of $37.69, for a total transaction of $296,469.54. Following the transaction, the insider directly owned 54,645 shares in the company, valued at $2,059,570.05. This trade represents a 12.58% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is available through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold 9,855 shares of company stock worth $371,112 in the last quarter. Company insiders own 5.40% of the company's stock.

Agios Pharmaceuticals Company Profile

Agios Pharmaceuticals, Inc is a biopharmaceutical company focused on discovering and developing medicines for rare diseases involving cellular metabolism. The company's research is centered on metabolic pathways that influence red blood cell production and function, with the goal of addressing conditions that have limited treatment options.

Agios' principal commercial product is Pyrukynd (mitapivat), an oral activator of pyruvate kinase. Pyrukynd is approved in the United States and other markets for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency, a rare inherited blood disorder.

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