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Agios Pharma (AGIO)
NASDAQ:AGIO

Agios Pharma (AGIO) AI Stock Analysis

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AGIO

Agios Pharma

(NASDAQ:AGIO)

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Neutral 52 (OpenAI - 5.2)
Rating:52Neutral
Price Target:
$28.00
▼(-7.38% Downside)
Action:ReiteratedDate:02/13/26
The score is held back primarily by weak financial performance driven by large ongoing operating losses and sustained negative cash flow, with additional pressure from a weak longer-term technical trend. Offsetting these are a constructive earnings-call outlook citing strong recent revenue growth, a new approval with early launch traction, disciplined expense guidance, and substantial cash resources.
Positive Factors
Strong revenue growth and commercial traction
Sustained double-digit revenue growth driven by Pyrukynd demonstrates expanding commercial adoption and validates go-to-market capabilities. Durable top-line momentum supports scaling fixed-cost absorption, strengthens negotiating leverage with payers, and underpins a realistic path to profitability if growth persists.
New FDA-approved therapy for thalassemia (AQVESME/Afesmi)
First-in-class approval for thalassemia creates a durable, addressable market and first-mover advantage. Approval plus REMS-managed launch establishes commercial infrastructure, pricing power, and long-term revenue potential that can diversify the portfolio beyond PK deficiency and support peak sales upside.
Strong cash position and conservative leverage
A ~$1.2B cash balance and low leverage provide financial flexibility to fund launches, trials and R&D without immediate dilution. This runway supports multi-indication development and potential commercialization of sickle cell and MDS programs, reducing near-term liquidity risk while the business scales.
Negative Factors
Sustained cash burn and operating losses
Recurring large operating losses and materially negative operating and free cash flow reflect structural unprofitability. If commercial expansion or trial outcomes disappoint, continued cash burn risks equity erosion or dilutive financing, constraining long-term capital allocation and strategic optionality.
High R&D and SG&A expense base
Large R&D and SG&A outlays relative to current revenue create a high fixed-cost structure that slows margin expansion. Sustained elevated spend is necessary for pipeline progress but raises the breakeven hurdle and heightens reliance on successful launches and trial readouts to achieve durable profitability.
Regulatory and launch frictions for new indications
Unclear regulatory pathway for sickle cell could require additional confirmatory trials, delaying approvals and peak sales. REMS requirements and treatment-initiation lags materially slow revenue realization from early scripts, reducing near-term conversion visibility and prolonging reliance on cash reserves.

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 generates revenue primarily through the commercialization of its approved therapies, particularly IDHIFA and TIBSOVO, which contribute to sales revenue from patients and healthcare providers. Additionally, the company may receive milestone payments and royalties from partnerships with larger pharmaceutical companies for the development and commercialization of its drug candidates. Collaborations, licensing agreements, and research partnerships can also provide significant revenue streams, contributing to Agios's overall earnings. The company is focused on expanding its portfolio of therapies and may generate further income through pipeline products as they advance through clinical trials and gain regulatory approval.

Agios Pharma Earnings Call Summary

Earnings Call Date:Feb 12, 2026
(Q4-2025)
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% Change Since: |
Next Earnings Date:Apr 30, 2026
Earnings Call Sentiment Positive
The call conveyed strong commercial and pipeline momentum: notable Q4 revenue growth (86% YoY), Afesmi U.S. approval and an encouraging early launch (44 prescriptions in five weeks), a robust near-term catalyst calendar, and a healthy balance sheet (~$1.2B). Offsetting risks include near-term revenue timing delays (10–12 week conversion from script to treatment), anticipated sequential U.S. revenue decline into early 2026 due to ordering and inventory dynamics, sizeable R&D/SG&A spend without a specific profitability timetable, and regulatory uncertainty around the sickle cell approval pathway. Overall, the positives (approval, growth, cash runway, and multiple upcoming data readouts) outweigh the operational and timing headwinds, supporting an optimistic outlook.
Q4-2025 Updates
Positive Updates
Strong Q4 and Full-Year Revenue Growth
Q4 worldwide Pyrukynd revenue of $20,000,000, up 86% year-over-year and up 55% sequentially from $13,000,000; full year 2025 revenue of $54,000,000.
Afesmi U.S. Approval and Launch
FDA approval for Afesmi in thalassemia (Dec 23, 2025) with REMS implemented late January 2026 and initial dispensing underway.
Early Afesmi Commercial Traction
44 prescriptions written by REMS-certified U.S. physicians in first five weeks (through Jan 30); early prescribers show broad geographic distribution and predominance of community physicians, with initial patient mix of transfusion-dependent and engaged non–transfusion-dependent patients.
Solid Balance Sheet and Financial Flexibility
Cash, cash equivalents and marketable securities of approximately $1,200,000,000 at year-end, providing runway to support Afesmi launch, sickle cell regulatory path and pipeline advancement.
Robust Pipeline with Multiple 2026 Catalysts
Key near-term catalysts: pre-sNDA meeting for mitapivat in sickle cell (Q1 2026); tebipivat Phase II top-line in lower-risk MDS (H1 2026) and Phase II sickle cell top-line (H2 2026); AG-236 Phase I top-line (H1 2026); initiation of AG-181 Phase 1b in PKU.
Commercial and Access Preparations
Single specialty pharmacy dispensing model and MyAgios patient support program in place; pharmacy education component of REMS completed; gross-to-net assumptions for thalassemia aligned with PK deficiency (~10%–20%).
Revenue Guidance and Operating Discipline
Company expects 2026 U.S. PK deficiency revenue of $45,000,000–$50,000,000 and anticipates operating expenses roughly flat with 2025, emphasizing disciplined capital allocation and a stated path to profitability.
Negative Updates
Anticipated Sequential Revenue Decline
Management expects a sequential decline in U.S. revenues into 2026 (Q1 impact) due to launch conversion timing and inventory/order dynamics.
Lag from Prescription to Revenue
Average expected time from first prescription to treatment initiation is 10–12 weeks because of prior-authorization processes and required baseline liver testing, delaying near-term revenue realization from early scripts.
High R&D Spend and SG&A Load
Q4 R&D expense of $88,100,000 (an increase of $5,300,000 versus 2024, ~6% increase); Q4 SG&A of $51,600,000 remains sizable—company did not provide a concrete timeline to profitability or breakeven revenue figure.
Regulatory Uncertainty in Sickle Cell Path
Pre-sNDA meeting for mitapivat planned for Q1 2026 to clarify regulatory path (full approval vs. accelerated/other pathways); potential need for confirmatory trials remains an open outcome.
Limited Early Ex-U.S. Commercialization
Q4 ex-U.S. revenue of $4,000,000 primarily reflects inventory stocking as Europe transitions from managed access; GCC (Saudi) distribution remains case-by-case named-patient access pending broader procurement, limiting near-term ex-U.S. uptake.
Visibility and Measurement Constraints
Single specialty pharmacy model means third-party script tracking (e.g., IQVIA) will not capture early Afesmi prescriptions, reducing external visibility into launch dynamics.
Company Guidance
The company guided that it expects 2026 operating expenses to be roughly flat with 2025 while targeting a clear path to profitability driven by its commercial portfolio (PK deficiency and newly approved Afesmi for thalassemia); specific financials noted on the call include Q4 2025 Pyrukynd revenue of $20.0M (up 86% year‑over‑year and +55% sequential from $13.0M) and full‑year 2025 revenue of $54M, Q4 U.S. revenue $16.0M (up 50% YoY) and ex‑U.S. $4.0M, Q4 cost of sales $1.9M, R&D $88.1M (up $5.3M vs. 2024), SG&A $51.6M, and cash, cash equivalents and marketable securities of ~ $1.2B; FY2026 U.S. PK deficiency revenue is expected to be $45–50M, gross‑to‑net for thalassemia is assumed ~10–20%, and the company expects prescriptions to convert to treatment initiation on average in 10–12 weeks (44 REMS‑certified prescriptions written by Jan 30); key 2026 catalysts include a pre‑sNDA meeting for mitapivat (Q1), Phase II tebipivat toplines in lower‑risk MDS (H1) and sickle cell disease (H2), Phase I AG‑236 topline (H1) and initiation of AG‑181 Phase 1b, with a combined pipeline market opportunity estimated at $10B.

Agios Pharma Financial Statement Overview

Summary
Strong revenue growth and generally high gross margins are positives, and leverage is low with sizable equity. However, the company is still far from operating breakeven with persistent, large operating losses and consistently deep negative operating/free cash flow, indicating ongoing cash burn.
Income Statement
34
Negative
Revenue is growing quickly (up 88% in 2023 and 21% in 2025), and gross profit margins are strong in most years (roughly mid-60% to high-80%), which is supportive of long-term operating leverage. However, operating losses remain very large versus the revenue base (EBITDA and EBIT deeply negative in every year shown), leading to significant net losses in 2022, 2023, and 2025. Net income also appears volatile (notably the large profit in 2021 and 2024 despite negative operating results), which reduces earnings quality and predictability.
Balance Sheet
72
Positive
The balance sheet looks conservatively levered, with low debt relative to equity (debt-to-equity generally ~0.03–0.09, higher in 2020 at ~0.26). Equity remains sizable, providing a cushion while the company operates at a loss. The main weakness is profitability: returns on equity swing sharply and are negative in most years, reflecting ongoing operating losses and creating risk of future equity erosion if losses persist.
Cash Flow
28
Negative
Cash generation is a clear weak spot: operating cash flow is consistently and materially negative each year, and free cash flow is also deeply negative. Free cash flow growth is unstable (improving in some years but deteriorating in others, including down ~9% in 2025), indicating the cash burn is not yet on a clear downward trajectory. While free cash flow is close to net income in several years, the underlying issue is that both are negative in key periods, implying continued reliance on balance-sheet resources or financing.
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue54.03M36.50M26.82M14.24M0.00
Gross Profit47.68M32.33M17.32M12.54M-18.78M
EBITDA-466.95M-420.08M-384.86M-380.48M-337.73M
Net Income-412.78M673.73M-352.09M-231.80M1.60B
Balance Sheet
Total Assets1.30B1.66B937.12M1.24B1.44B
Cash, Cash Equivalents and Short-Term Investments854.42M893.71M776.93M783.12M1.02B
Total Debt62.02M56.99M72.00M85.66M97.09M
Total Liabilities104.11M122.24M126.10M137.90M145.76M
Stockholders Equity1.19B1.54B811.02M1.10B1.29B
Cash Flow
Free Cash Flow-377.29M-391.53M-297.06M-314.36M-413.06M
Operating Cash Flow-372.98M-389.84M-296.06M-309.48M-407.32M
Investing Cash Flow377.18M363.44M239.57M243.26M1.25B
Financing Cash Flow8.68M14.44M5.43M2.35M-765.77M

Agios Pharma Technical Analysis

Technical Analysis Sentiment
Positive
Last Price30.23
Price Trends
50DMA
27.67
Positive
100DMA
32.33
Negative
200DMA
34.09
Negative
Market Momentum
MACD
0.53
Negative
RSI
62.23
Neutral
STOCH
78.08
Neutral
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 30.23 is above the 20-day moving average (MA) of 28.17, above the 50-day MA of 27.67, and below the 200-day MA of 34.09, indicating a neutral trend. The MACD of 0.53 indicates Negative momentum. The RSI at 62.23 is Neutral, neither overbought nor oversold. The STOCH value of 78.08 is Neutral, 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 54 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
56
Neutral
$4.08B-20.30-28.29%
55
Neutral
$3.36B-7.13-44.44%-5.30%
54
Neutral
$10.05B-25.091025.95%52.91%
53
Neutral
$1.91B-2.47-59.54%-32.98%-18.46%
52
Neutral
$1.77B-4.25-30.20%36.26%-158.98%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$4.78B-16.21-38.41%-58.35%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AGIO
Agios Pharma
30.23
-2.89
-8.73%
IBRX
ImmunityBio
9.78
6.93
243.16%
DNLI
Denali Therapeutics
21.18
5.98
39.34%
NAMS
NewAmsterdam Pharma Company
35.46
15.19
74.94%
RXRX
Recursion Pharmaceuticals
3.67
-2.92
-44.31%
APGE
Apogee Therapeutics
70.00
38.61
123.00%

Agios Pharma Corporate Events

Business Operations and StrategyProduct-Related Announcements
Agios Pharma Sets 2026 Strategic Priorities After AQVESME Approval
Positive
Jan 12, 2026

On January 12, 2026, Agios outlined its 2026 strategic priorities following the December 2025 U.S. approval of AQVESME (mitapivat) for anemia in adults with alpha- or beta-thalassemia, marking the first and only FDA-approved treatment for both non-transfusion-dependent and transfusion-dependent forms of the disease. The company is launching AQVESME in the U.S. with a REMS program in place due to hepatocellular injury risks and expects the drug to become commercially available in late January 2026, while also highlighting a path to profitability supported by its existing rare disease portfolio and the potential to exceed $1 billion in peak global sales. Agios plans to advance mitapivat into sickle cell disease with a U.S. regulatory submission anticipated after a pre-sNDA meeting in early 2026, report key 2026 clinical milestones for tebapivat in sickle cell disease and lower-risk myelodysplastic syndromes, and generate early-stage data in polycythemia vera and phenylketonuria, reinforcing its strategy to diversify across hematologic and rare diseases and strengthen its competitive position in the rare disease therapeutics market.

The most recent analyst rating on (AGIO) stock is a Buy with a $35.00 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: Feb 13, 2026