AGIOHIGH SIGNALFINANCIAL10-K

AGIO experienced a massive $1.09 billion swing from profit to loss despite doubling revenue, indicating significant one-time charges or writedowns that weren't present in the prior year.

The dramatic reversal from $673.7M profit to $412.8M loss represents a staggering financial deterioration that likely stems from major one-time events, asset impairments, or accounting adjustments rather than operational performance given the strong revenue growth. This volatility suggests significant underlying business changes that investors need to investigate further, particularly given the company's dependence on clinical-stage products and recent FDA approvals.

Comparing 2026-02-12 vs 2025-02-13View on EDGAR →
FINANCIAL ANALYSIS

AGIO's financials show a paradoxical pattern with revenue doubling to $30M and modest increases in operating expenses (R&D up 12.7%, SG&A up 15%), yet the company swung from $674M profit to $413M loss—a $1.09B deterioration. The balance sheet contracted significantly with total assets falling 22% to $1.3B and stockholders' equity dropping 22.6% to $1.2B, while cash actually improved and liabilities decreased, suggesting major non-cash charges or asset writedowns drove the massive loss. This represents an extraordinary financial transformation that requires immediate investigation into the underlying causes.

FINANCIAL STATEMENT CHANGES
Net Income
P&L
-161.3%
$673.7M-$412.8M

Net income declined 161.3% — review whether driven by operations, interest costs, or non-recurring items.

Capital Expenditure
Cash Flow
+156.1%
$1.7M$4.3M

Capital expenditure jumped 156.1% — major investment cycle underway; assess returns on deployment.

Revenue
P&L
+97.5%
$15.2M$30.0M

Strong top-line growth of 97.5% — accelerating demand or successful expansion into new markets.

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.

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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