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Agios Pharma (AGIO)
NASDAQ:AGIO
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Agios Pharma (AGIO) AI Stock Analysis

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AGIO

Agios Pharma

(NASDAQ:AGIO)

Rating:60Neutral
Price Target:
$38.00
▲(5.18% Upside)
Agios Pharma's overall stock score reflects a mix of strengths and challenges. The company's strong equity position and recent positive corporate events are offset by operational profitability issues and liquidity concerns. The stock's undervaluation and positive earnings call sentiment provide some upside potential, but investors should be cautious of the financial performance risks.
Positive Factors
Approval Process
The request for a REMS rather than an outright CRL or request for more safety data is a positive sign that the FDA will approve Pyrukynd for thal.
International Approvals
Saudi FDA approval for Pyrukynd in thalassemia is seen as a positive development.
Market Potential
Mitapivat is expected to be tried by up to 50% of transfusion-dependent patients within 5 years, especially as a first step in treatment before gene therapy.
Negative Factors
Adverse Events
AGIO shares appear to have been under pressure from three deaths in Pyrukynd patients that newly appeared in the FDA’s FAERS database.
Drug Monitoring
In both of these newly added patients the reporter deems Pyrukynd as most likely to be associated with the event, the stronger of the two endorsement levels available in FAERS.
Safety Concerns
It is difficult to fully dismiss the impact of the safety concerns on the PDUFA, especially if other non-fatal FAERS entries suggest a risk for liver injury.

Agios Pharma (AGIO) vs. SPDR S&P 500 ETF (SPY)

Agios Pharma Business Overview & Revenue Model

Company DescriptionAgios Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery and development of medicines in the field of cellular metabolism and adjacent areas of biology. The company offers PYRUKYND (mitapivat) an activator of both wild-type and a variety of mutant pyruvate kinase, PK, enzymes for the treatment of hemolytic anemias; and AG-946 that is in Phase I clinical study for treating hemolytic anemias and other indications. Agios Pharmaceuticals, Inc. was incorporated in 2007 and is headquartered in Cambridge, Massachusetts.
How the Company Makes MoneyAgios Pharmaceuticals generates revenue primarily through the sale of its pharmaceutical products, particularly ivosidenib, which has been approved by regulatory authorities and is marketed to healthcare providers. The company also earns revenue from collaborations and partnerships with other pharmaceutical companies that may involve co-development or commercialization agreements. These partnerships often provide upfront payments, milestone payments based on the achievement of specific development or sales targets, and royalties on future sales. Additionally, Agios may receive funding from research grants or government initiatives aimed at supporting the development of therapies for rare diseases.

Agios Pharma Earnings Call Summary

Earnings Call Date:Jul 31, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Oct 30, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook with strong revenue growth for PYRUKYND, advancements in regulatory approvals, and strategic partnerships to expand global reach. However, there were also concerns about revenue variability, increased expenses, and challenges in market expansion, which could temper expectations. Overall, the highlights outweigh the lowlights, suggesting a positive sentiment.
Q2-2025 Updates
Positive Updates
Strong Revenue Growth for PYRUKYND
Second quarter net revenue was $12.5 million, marking a 45% increase compared to the second quarter of 2024 and a 44% increase from the first quarter of 2025.
Advancements in Regulatory Approvals and Trials
Agios anticipates the FDA approval of PYRUKYND for thalassemia in the U.S. by September 7. The company expects to report the Phase III RISE UP trial results for PYRUKYND in sickle cell disease by the end of the year.
Strategic Partnerships to Expand Global Reach
Agios entered agreements with Avanzanite Bioscience for Europe and NewBridge Pharmaceuticals for the GCC to commercialize PYRUKYND, enhancing its global presence.
Robust Financial Position
Agios ended the second quarter with approximately $1.3 billion in cash, cash equivalents, and marketable securities, supporting their capital allocation strategy.
Pipeline Progress
The company dosed the first patient in the Phase II trial of tebapivat for sickle cell disease and received IND clearance for AG-236, marking key advancements in their pipeline.
Negative Updates
Variability in Revenue Expectations
Agios anticipates continued quarter-on-quarter variability in net revenues due to ordering patterns and expects only modest growth for 2025 compared to 2024.
R&D and SG&A Expenses Increase
R&D expenses rose by $14.5 million to $91.9 million due to a milestone payment to Alnylam, and SG&A expenses increased by $10.4 million to $45.9 million, driven by investment in the potential launch of PYRUKYND for thalassemia.
Potential Challenges in Market Expansion
The launch of PYRUKYND in new markets like the GCC may take up to two years due to the need for national procurement agreements, which could delay revenue realization.
Company Guidance
During Agios' Second Quarter 2025 conference call, the company provided several key metrics and guidance for the upcoming period. Agios reported $12.5 million in net revenue for the quarter, marking a 45% increase from the same period in 2024 and a 44% increase from the first quarter of 2025. The company is focusing on the commercial launch of PYRUKYND, particularly in the U.S., pending FDA approval for thalassemia, with a PDUFA goal date set for September 7, 2025. Agios is also anticipating the RISE UP Phase III trial readout for PYRUKYND in sickle cell disease by the end of the year and expects Phase IIb data for tebapivat in early 2026. The company ended the quarter with approximately $1.3 billion in cash, cash equivalents, and marketable securities, and plans to maintain a disciplined investment strategy to support ongoing and future developments. Additionally, Agios highlighted its strategic partnerships, including agreements with Avanzanite Bioscience in Europe and NewBridge Pharmaceuticals in the GCC, to expand the global reach of PYRUKYND.

Agios Pharma Financial Statement Overview

Summary
Agios Pharma shows significant operational challenges with negative EBIT and EBITDA margins, reflecting substantial losses. A strong equity position is overshadowed by negative cash flow and profitability, posing financial risks.
Income Statement
35
Negative
Agios Pharma's income statement shows significant volatility with negative EBIT and EBITDA margins, indicating operational challenges. Despite recent revenue growth, net profit margins remain negative, reflecting substantial losses. The company's gross profit margin is positive, but overall profitability is impacted by high operational costs.
Balance Sheet
65
Positive
The balance sheet reveals a strong equity position with a low debt-to-equity ratio, indicating financial stability. However, the return on equity is negative due to consistent net losses, which could be concerning if trends don't reverse. The equity ratio is solid, suggesting good asset coverage by equity.
Cash Flow
45
Neutral
Cash flow analysis points to negative operating cash flow, indicating potential liquidity issues. Free cash flow remains negative, though there's a positive trend in free cash flow growth recently. The operating cash flow to net income ratio is unfavorable, highlighting the need for improved cash generation.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue40.88M36.50M26.82M14.24M0.00203.20M
Gross Profit34.79M32.33M17.32M12.54M-18.78M200.39M
EBITDA-442.59M-425.74M-384.86M-380.48M-337.73M-326.13M
Net Income650.08M673.73M-352.09M-74.56M1.60B-335.22M
Balance Sheet
Total Assets1.47B1.66B937.12M1.24B1.44B852.95M
Cash, Cash Equivalents and Short-Term Investments938.94M893.71M776.93M1.10B1.29B670.54M
Total Debt48.76M56.99M72.00M85.66M97.09M105.20M
Total Liabilities101.68M122.24M126.10M137.90M145.76M453.45M
Stockholders Equity1.37B1.54B811.02M1.10B1.29B399.50M
Cash Flow
Free Cash Flow-409.02M-391.53M-297.06M-314.36M-413.06M-305.67M
Operating Cash Flow-406.00M-389.84M-296.06M-309.48M-407.32M-290.76M
Investing Cash Flow393.19M363.44M239.57M243.26M1.25B75.75M
Financing Cash Flow9.16M14.44M5.43M2.35M-765.77M261.52M

Agios Pharma Technical Analysis

Technical Analysis Sentiment
Negative
Last Price36.13
Price Trends
50DMA
37.39
Negative
100DMA
34.04
Positive
200DMA
35.67
Positive
Market Momentum
MACD
0.39
Negative
RSI
45.10
Neutral
STOCH
70.02
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AGIO, the sentiment is Negative. The current price of 36.13 is below the 20-day moving average (MA) of 37.40, below the 50-day MA of 37.39, and above the 200-day MA of 35.67, indicating a neutral trend. The MACD of 0.39 indicates Negative momentum. The RSI at 45.10 is Neutral, neither overbought nor oversold. The STOCH value of 70.02 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for AGIO.

Agios Pharma Risk Analysis

Agios Pharma disclosed 53 risk factors in its most recent earnings report. Agios Pharma reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Agios Pharma Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
61
Neutral
$2.77B-28.43%
60
Neutral
$2.28B3.6864.05%30.57%
51
Neutral
$7.91B-0.36-41.71%2.23%23.45%-1.86%
50
Neutral
$2.03B-86.34%30.14%-10.08%
49
Neutral
$2.26B-34.12%-79.09%
46
Neutral
$2.26B78.99%4227.22%50.80%
45
Neutral
$2.26B-39.69%-100.00%1.62%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AGIO
Agios Pharma
36.13
-7.15
-16.52%
IBRX
ImmunityBio
2.39
-0.99
-29.29%
DNLI
Denali Therapeutics
14.79
-10.46
-41.43%
NAMS
NewAmsterdam Pharma Company
25.66
9.26
56.46%
RXRX
Recursion Pharmaceuticals
4.52
-1.40
-23.65%
APGE
Apogee Therapeutics
37.13
-10.12
-21.42%

Agios Pharma Corporate Events

Product-Related AnnouncementsRegulatory Filings and Compliance
Agios Pharma’s PYRUKYND Approved by Saudi Authority
Positive
Aug 4, 2025

Agios Pharmaceuticals addressed a recent securities analyst report detailing adverse event data from the FDA’s reporting system concerning its drug PYRUKYND. The report highlighted four patient cases, but Agios maintains that the information has not changed the drug’s established benefit-risk profile. The company continues to prioritize patient safety through rigorous pharmacovigilance processes. Additionally, on August 4, 2025, the Saudi Food and Drug Authority approved PYRUKYND for treating adult patients with specific types of thalassemia, potentially expanding its market reach.

Executive/Board ChangesBusiness Operations and Strategy
Agios Pharma Appoints Dr. Jay Backstrom as Director
Positive
Jul 8, 2025

On July 3, 2025, Agios Pharmaceuticals announced the election of Dr. Jay Backstrom as a class III director, effective July 8, 2025, with a term lasting until the 2028 Annual Meeting of Stockholders. Dr. Backstrom will also join the Science and Technology Committee and receive compensation in line with the company’s non-employee director policy, including cash compensation and stock options. This strategic addition to the board is expected to enhance Agios’s focus on scientific and technological advancements, potentially impacting its market positioning and stakeholder relations positively.

Executive/Board ChangesShareholder MeetingsBusiness Operations and Strategy
Agios Pharma Increases Shares in Stock Incentive Plan
Positive
Jun 18, 2025

At the 2025 Annual Meeting of Stockholders held on June 18, Agios Pharmaceuticals’ stockholders approved an amendment to the 2023 Stock Incentive Plan, increasing the number of shares available for issuance by 2,500,000. Additionally, the stockholders elected two directors, approved executive compensation, and ratified the appointment of PricewaterhouseCoopers LLP as the independent auditor for the fiscal year, reflecting strong support for the company’s strategic direction.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Sep 05, 2025