AGIOMEDIUM SIGNALFINANCIAL10-K

AGIO experienced a substantial revenue decline while operating losses deepened amid continued heavy R&D investment and successful FDA approval of AQVESME for thalassemia treatment.

The company has achieved a significant regulatory milestone with FDA approval of mitapivat (branded as AQVESME) for thalassemia in the U.S., establishing distinct branding between its FDA-approved product and other mitapivat formulations under development. However, the substantial revenue contraction alongside increased operating expenses suggests challenges in commercial execution or timing of product launches that investors should monitor closely.

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FINANCIAL ANALYSIS

AGIO's financial profile shows mixed signals with revenue declining substantially to $43.0M while both R&D expenses grew to $339.5M and SG&A expenses increased to $180.3M, resulting in deeper operating losses of $472.1M. The balance sheet contracted meaningfully with total assets falling to $1.3B and stockholders' equity declining to $1.2B, though the company maintained adequate liquidity with cash increasing to $89.1M. The financial picture reflects a company investing heavily in development while navigating commercial challenges, typical of a biotech firm transitioning between clinical and commercial stages.

FINANCIAL STATEMENT CHANGES
Revenue
P&L
-38.5%
$69.9M$43.0M

Revenue declined 38.5% — significant demand weakness or market share loss warrants investigation.

Stockholders Equity
Balance Sheet
-22.6%
$1.5B$1.2B

Equity decreased 22.6% — buybacks or losses reducing book value, monitor solvency ratios.

Total Assets
Balance Sheet
-22%
$1.7B$1.3B

Total assets contracted 22% — asset sales, write-downs, or balance sheet optimization underway.

Inventory
Balance Sheet
+19.2%
$27.6M$32.9M

Inventory built 19.2% — monitor whether demand supports this build or if write-downs may follow.

Cash & Equivalents
Balance Sheet
+16.9%
$76.2M$89.1M

Cash grew 16.9% — improving liquidity position supports investment and shareholder returns.

SG&A Expense
P&L
+15%
$156.8M$180.3M

SG&A increased modestly — likely reflects growth-related hiring or sales expansion investment.

Total Liabilities
Balance Sheet
-14.8%
$122.2M$104.1M

Liabilities reduced 14.8% — deleveraging improves balance sheet strength and financial flexibility.

R&D Expense
P&L
+12.7%
$301.3M$339.5M

R&D investment increased 12.7% — signals commitment to future product development, though near-term margin impact.

Operating Income
P&L
-10.9%
-$425.7M-$472.1M

Operating profitability softening — costs rising faster than revenue, watch for margin recovery plan.

LANGUAGE CHANGES
NEW — 2026-02-12
PRIOR — 2025-02-13
ADDED
As of February 6, 2026, there were 58,592,172 shares of Common Stock, $0.001 par value per share, outstanding.
In addition, unless otherwise stated or the context indicates otherwise, all references in this Annual Report on Form 10-K to AQVESME (mitapivat) or AQVESME refer to our FDA-approved medicine for the treatment of anemia in adults with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia in the United States; references to PYRUKYND (mitapivat) , PYRUKYND , or mitapivat refer to all other commercially available mitapivat products or mitapivat product candidates for which we are exploring further applications and indications, as the context requires.
Our ability to generate product revenue from PYRUKYND and AQVESME depends heavily on our successful development and commercialization of the products.
We depend heavily on the success of our clinical-stage product candidates, including the potential approval of mitapivat for the treatment of thalassemia in the European Union, or sickle cell disease in the United States and in other jurisdictions.
We provide certain development estimates related to the development and regulatory approval of our product candidates, including mitapivat.
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REMOVED
As of February 7, 2025, there were 57,296,167 shares of Common Stock, $0.001 par value per share, outstanding.
Our ability to generate product revenue from PYRUKYND depends heavily on our successful development and commercialization of the product.
We depend heavily on the success of our clinical-stage product candidates, including the potential approval of PYRUKYND for the treatment of thalassemia or sickle cell disease, or SCD, in the United States and in other jurisdictions.
The results of completed clinical trials of PYRUKYND for the treatment of PK deficiency and thalassemia are not predictive of our ongoing clinical trials of PYRUKYND in other indications, such as SCD, and the results of our early-stage clinical trials of tebapivat are not predictive of our later stage clinical trials of tebapivat.
We provide certain development estimates related to the development and regulatory approval of PYRUKYND and our product candidates.
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