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Agios Pharma (AGIO)
NASDAQ:AGIO

Agios Pharma (AGIO) AI Stock Analysis

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Agios Pharma

(NASDAQ:AGIO)

56Neutral
Agios Pharma's stock reflects a cautious investment stance. The company has a strong balance sheet and promising growth prospects in the rare disease sector, as highlighted in the earnings call. However, ongoing operational inefficiencies, negative cash flows, and bearish technical indicators pose significant risks. The low P/E ratio suggests undervaluation, but the lack of dividend yield and limited revenue growth for PK deficiency warrant caution.
Positive Factors
Product Development
Mitapivat is viewed as a pipeline-in-a-product with potential for new and larger label expansions in thalassemia and sickle cell disease, creating a significant commercial advantage.
Regulatory Progress
Mitapivat's sNDA is under review with the FDA with a PDUFA date set, and launch preparation is ongoing.
Negative Factors
Safety Concerns
Concerns over hepatocellular injury have negatively impacted AGIO stock, which is down approximately 45% due to these issues observed in thalassemia patients.

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

Agios Pharma Business Overview & Revenue Model

Company DescriptionAgios Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the discovery and development of novel investigational medicines to treat cancer and rare genetic diseases. It focuses on diseases that are directly caused by changes in genes or chromosomes, often passed from one generation to the next. The company was founded by Lewis Clayton Cantley, Tak W. Mak, Craig B. Thompson and Shin-Shan Michael Su on August 7, 2007 and is headquartered in Cambridge, MA.
How the Company Makes MoneyAgios Pharmaceuticals primarily generates revenue through the commercialization of its proprietary pharmaceutical products. The company earns money by selling its approved drugs to healthcare providers, hospitals, and specialty pharmacies. Additionally, Agios engages in strategic collaborations and partnerships with other pharmaceutical and biotechnology companies to co-develop or license its therapies, which can result in milestone payments and royalties. These partnerships are significant as they provide additional financial resources and expertise to advance the development and distribution of Agios' products. Moreover, Agios invests in research and development to expand its product pipeline, aiming to introduce new therapies that can further enhance its revenue potential.

Agios Pharma Financial Statement Overview

Summary
Agios Pharma presents a mixed financial picture. While revenue improvements and a strong balance sheet provide a solid foundation, persistent operational losses and negative cash flows highlight underlying challenges. The focus should be on enhancing operational efficiency and cash generation to sustain growth and profitability in the long term.
Income Statement
45
Neutral
Agios Pharma shows a challenging income statement with a substantial net profit margin improvement in the latest year due to a significant net income increase, likely from one-time events. However, EBIT and EBITDA margins remain deeply negative, indicating operational inefficiencies or high operating costs. The revenue growth is notable, but profitability remains a concern.
Balance Sheet
60
Neutral
The balance sheet reflects a strong equity base with a high equity ratio, indicating financial stability. The debt-to-equity ratio is low, suggesting conservative leverage use. Despite low liabilities, the company holds a strong cash position, supporting its operational runway. However, consistent net losses could weaken equity over time.
Cash Flow
55
Neutral
Free cash flow remains negative, though investing cash flows are positive, indicating strategic investments. Operating cash flow to net income ratio is concerning due to negative operating cash flows despite positive net income, suggesting non-recurring income sources. The company needs to improve cash generation from core operations.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
36.50M26.82M14.24M0.00203.20M
Gross Profit
32.33M17.32M12.54M-18.78M200.39M
EBIT
-425.74M-391.49M-389.05M-378.42M-316.15M
EBITDA
-425.74M-384.86M-380.48M-337.73M-326.13M
Net Income Common Stockholders
673.73M-352.09M-74.56M1.60B-335.22M
Balance SheetCash, Cash Equivalents and Short-Term Investments
893.71M776.93M1.10B1.29B670.54M
Total Assets
1.66B937.12M1.24B1.44B852.95M
Total Debt
56.99M72.00M85.66M97.09M105.20M
Net Debt
-19.26M-16.21M-53.60M-106.03M-22.24M
Total Liabilities
122.24M126.10M137.90M145.76M453.45M
Stockholders Equity
1.54B811.02M1.10B1.29B399.50M
Cash FlowFree Cash Flow
-391.53M-297.06M-314.36M-413.06M-305.67M
Operating Cash Flow
-389.84M-296.06M-309.48M-407.32M-290.76M
Investing Cash Flow
363.44M239.57M243.26M1.25B75.75M
Financing Cash Flow
14.44M5.43M2.35M-765.77M261.52M

Agios Pharma Technical Analysis

Technical Analysis Sentiment
Negative
Last Price31.98
Price Trends
50DMA
33.70
Negative
100DMA
41.36
Negative
200DMA
42.88
Negative
Market Momentum
MACD
-0.63
Positive
RSI
38.88
Neutral
STOCH
14.06
Positive
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 31.98 is below the 20-day moving average (MA) of 33.69, below the 50-day MA of 33.70, and below the 200-day MA of 42.88, indicating a bearish trend. The MACD of -0.63 indicates Positive momentum. The RSI at 38.88 is Neutral, neither overbought nor oversold. The STOCH value of 14.06 is Positive, 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 (49)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
69
Neutral
$9.77B41.8619.71%52.97%
56
Neutral
$1.84B2.8157.29%36.07%
49
Neutral
$6.90B0.02-54.05%2.46%24.91%-3.14%
46
Neutral
$302.72M-71.87%-15.14%15.84%
42
Neutral
$38.57M-270.20%144.50%-141.91%
42
Neutral
$110.00M-54.21%-78.55%-0.92%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AGIO
Agios Pharma
31.98
2.52
8.55%
SRPT
Sarepta Therapeutics
99.77
-23.99
-19.38%
BLUE
Bluebird Bio
3.73
-22.87
-85.98%
FATE
Fate Therapeutics
1.01
-6.22
-86.03%
RGNX
RegenXBio
6.55
-15.30
-70.02%

Agios Pharma Earnings Call Summary

Earnings Call Date: Feb 13, 2025 | % Change Since: -2.53% | Next Earnings Date: May 1, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant progress in the development pipeline, with major milestones expected in thalassemia and sickle cell disease. Strong revenue growth from PYRUKYND and a robust financial position are positive indicators. However, higher operating expenses and limited revenue growth for PK deficiency were noted as challenges.
Highlights
PYRUKYND Revenue Growth
Fourth quarter 2024 net PYRUKYND revenue was $10.7 million, an increase of 51% compared to $7.1 million in the fourth quarter of 2023.
Successful Pediatric Trials
Top line results from the ACTIVATE KIDS Phase III trial showed a 31.6% hemoglobin response in the mitapivat arm compared to 0% in the placebo arm.
Thalassemia and Sickle Cell Disease Pipeline Progress
Potential approval and launch of PYRUKYND in thalassemia expected in September 2025, with sickle cell disease in 2026. Phase III RISE up study for sickle cell disease completed enrollment.
Strong Financial Position
Agios ended the fourth quarter with cash, cash equivalents, and marketable securities of approximately $1.5 billion.
Regulatory and Clinical Milestones
The September 7 PDUFA goal date for PYRUKYND in thalassemia and the Phase III readout of RISE study in sickle cell disease by the end of 2025.
Lowlights
Higher Operating Expenses
G&A expenses were $51.7 million for the fourth quarter, an increase of $16.4 million compared to the prior year quarter, driven by commercial-related activities.
Limited 2025 Revenue Growth for PK Deficiency
2025 revenues for PK deficiency expected to be relatively flat compared to 2024 despite expansion into pediatric populations.
Company Guidance
During Agios' Fourth Quarter 2024 Conference Call, the company highlighted several key metrics and guidance points for the upcoming year. Agios anticipates a potential approval and commercial launch of their lead product, PYRUKYND, for thalassemia in September 2025, and for sickle cell disease in 2026. The company also reported $10.7 million in net PYRUKYND revenue for the fourth quarter of 2024, reflecting a 51% increase from the previous year. Agios plans to execute a strategy focused on expanding PYRUKYND's indications, advancing its robust pipeline, and strategically deploying capital to sustain and drive growth. Additionally, Agios expects 2025 revenues for PYRUKYND in PK deficiency to remain relatively flat compared to 2024, as they shift focus to the anticipated launch in thalassemia. With a strong balance sheet of approximately $1.5 billion, Agios aims to independently grow and capitalize on upcoming opportunities, underscoring their commitment to deliver innovative therapies for rare diseases.

Agios Pharma Corporate Events

Executive/Board Changes
Agios Pharma Board Member Announces Resignation
Neutral
Feb 13, 2025

On February 10, 2025, Dr. David P. Schenkein announced his resignation from the Board of Directors of Agios Pharmaceuticals, effective February 28, 2025. Despite stepping down from the Board and its Science and Technology Committee, Dr. Schenkein will continue to play a strategic advisory role, aiding the company’s leadership in advancing clinical development programs.

Product-Related AnnouncementsBusiness Operations and Strategy
Agios Pharma Sets Milestones for Rare Disease Growth
Positive
Jan 13, 2025

Agios Pharmaceuticals announced key milestones for 2025, showcasing its strong position in advancing its rare disease portfolio, especially with its drug PYRUKYND. The company plans to launch two commercial products over the next two years and continue to solidify its pipeline, backed by a robust financial position and strategic partnerships. Anticipated milestones include FDA decisions for PYRUKYND in thalassemia, potential U.S. commercial launch plans for sickle cell disease treatments, and significant clinical studies across their pipeline, reflecting their commitment to growth and innovation in the rare disease sector.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.