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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:58Neutral
Price Target:
$38.00
▲(3.60% Upside)
Agios Pharma's overall stock score is driven by a strong valuation and positive corporate events, which are offset by challenges in financial performance and mixed technical indicators. The company's promising earnings call highlights potential growth, but operational and cash flow issues remain significant risks.
Positive Factors
Financial Performance
Pyrukynd revenues were $12.5 million, a ~30% beat vs. consensus.
Regulatory Approval
Saudi FDA approval for Pyrukynd in thalassemia is seen as a positive development.
Strategic Partnerships
The distribution agreement with Avanzanite Bioscience in the EU and with NewBridge in the GCC should permit Agios to focus on the US opportunity and launch, a positive in our view.
Negative Factors
Market Pressure
AGIO shares appear to have been under pressure from three deaths in Pyrukynd patients that newly appeared in the FDA’s FAERS database.
Patient Safety
Two of the recent deaths were in young patients, specifically 28 and 26 years old, which raises concerns due to their age.
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: -2.29%|
Next Earnings Date:Oct 30, 2025
Earnings Call Sentiment Positive
The earnings call reflects a positive outlook with strong revenue growth, substantial financial resources, and promising advancements in clinical trials and strategic partnerships. However, there are challenges related to increased expenses, anticipated revenue variability, and regulatory considerations. The company shows a clear path toward growth but must address these lowlights effectively.
Q2-2025 Updates
Positive Updates
Significant Revenue Growth
Second quarter net PYRUKYND revenue was $12.5 million, an increase of 45% compared to $8.6 million in the second quarter of 2024 and an increase of 44% compared to $8.7 million in the first quarter of 2025.
Strong Financial Position
Exited the second quarter with approximately $1.3 billion in cash, cash equivalents, and marketable securities.
Positive Developments in Clinical Trials
Dosed the first patient in the Phase II trial of tebapivat in sickle cell disease and received IND clearance for AG-236.
Thalassemia and Sickle Cell Disease Advancements
Anticipated FDA approval for PYRUKYND in thalassemia and upcoming Phase III trial readout for sickle cell disease.
Strategic Partnerships
Entered agreement with Avanzanite Bioscience to commercialize and distribute PYRUKYND in Europe and partnership with NewBridge Pharmaceuticals for the GCC region.
Negative Updates
Increased Expenses
R&D expenses increased by $14.5 million compared to the second quarter of 2024, driven by a $10 million milestone payment to a partner.
Potential Revenue Variability
Anticipate quarter-on-quarter variability in net revenues due to ordering patterns and softer PKD demand as focus shifts to thalassemia.
Regulatory and Safety Considerations
Ongoing concerns about hepatocellular injury risk, and need for updated safety information in labeling discussions with FDA.
Company Guidance
During Agios' second quarter 2025 conference call, the company provided promising guidance for the remainder of the year, emphasizing several key metrics. Agios reported $12.5 million in net revenue for the quarter, marking a 45% increase from the same period in 2024 and a 44% rise from the first quarter of 2025. The company is optimistic about the upcoming FDA approval of PYRUKYND for thalassemia, with the PDUFA goal date set for September 7, 2025. Additionally, Agios is on track to release results from the RISE UP Phase III trial for PYRUKYND in sickle cell disease by the end of the year and anticipates Phase IIb data for tebapivat in early 2026. The company exited the second quarter with approximately $1.3 billion in cash, cash equivalents, and marketable securities, positioning it well for future investments. Agios also highlighted its strategic agreements with Avanzanite Bioscience and NewBridge Pharmaceuticals to expand PYRUKYND's reach in Europe and the GCC region, respectively.

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
Positive
Last Price36.68
Price Trends
50DMA
36.37
Positive
100DMA
32.68
Positive
200DMA
36.56
Positive
Market Momentum
MACD
-0.21
Positive
RSI
49.43
Neutral
STOCH
82.56
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AGIO, the sentiment is Positive. The current price of 36.68 is below the 20-day moving average (MA) of 37.56, above the 50-day MA of 36.37, and above the 200-day MA of 36.56, indicating a neutral trend. The MACD of -0.21 indicates Positive momentum. The RSI at 49.43 is Neutral, neither overbought nor oversold. The STOCH value of 82.56 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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
64
Neutral
$2.83B-28.43%
58
Neutral
$2.13B3.3264.05%30.57%
51
Neutral
$7.44B-0.20-46.00%2.26%22.80%-2.27%
49
Neutral
$2.56B78.99%4227.22%50.80%
49
Neutral
$2.27B-34.12%-79.09%
47
Neutral
$2.45B-86.34%30.14%-10.08%
45
Neutral
$2.11B-39.69%-100.00%1.62%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AGIO
Agios Pharma
36.68
-8.35
-18.54%
IBRX
ImmunityBio
2.71
-1.30
-32.42%
DNLI
Denali Therapeutics
14.46
-8.56
-37.19%
NAMS
NewAmsterdam Pharma Company
25.17
9.14
57.02%
RXRX
Recursion Pharmaceuticals
5.77
-0.97
-14.39%
APGE
Apogee Therapeutics
38.12
-7.13
-15.76%

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.

The most recent analyst rating on (AGIO) stock is a Hold with a $56.00 price target. To see the full list of analyst forecasts on Agios Pharma stock, see the AGIO Stock Forecast page.

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.

The most recent analyst rating on (AGIO) stock is a Hold with a $56.00 price target. To see the full list of analyst forecasts on Agios Pharma stock, see the AGIO Stock Forecast page.

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.

The most recent analyst rating on (AGIO) stock is a Hold with a $56.00 price target. To see the full list of analyst forecasts on Agios Pharma stock, see the AGIO Stock Forecast page.

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: Aug 14, 2025