agio-20250630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number: 001-36014

AGIOS PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)


Delaware									26-0662915
(State or Other Jurisdiction of Incorporation or Organization)									(I.R.S. Employer Identification No.)

88 Sidney Street, Cambridge, Massachusetts									'02139
(Address of Principal Executive Offices)									(Zip Code)

(617) 649-8600

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, Par Value $0.001 per share	AGIO	Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on July 25, 2025: 58,101,518

Table of Contents

AGIOS PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2025

TABLE OF CONTENTS


		Page No.
PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of June 30 , 2025 and December 31, 2024	1
	Condensed Consolidated Statements of Operations for the Three and S ix Months Ended June 30 , 2025 and 2024	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and S ix Months Ended June 30 , 2025 and 2024	3
	Condensed Consolidated Statements of Stockholders' Equity for the Three and Six Months Ended June 3 0 , 2025 and 2024	4
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30 , 2025 and 2024	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28
Item 4.	Controls and Procedures	28
PART II. OTHER INFORMATION		29
Item 1A.	Risk Factors	29
Item 5.	Other Information	57
Item 6.	Exhibits	58
	Signatures	59

Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(Unaudited)


(In thousands, except share and per share data)	June 30, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	80,871	$	76,247
Marketable securities	858,066		817,463
Accounts receivable, net	4,986		4,109



Inventory	30,848		27,616
Prepaid expenses and other current assets	44,693		40,165

Total current assets	1,019,464		965,600
Marketable securities	400,467		638,321
Operating lease assets	36,785		42,879
Property and equipment, net	10,579		11,675
Other non-current assets	3,942		4,724

Total assets	$	1,471,237	$	1,663,199
Liabilities and stockholders’ equity
Current liabilities:

Accounts payable	$	17,532	$	16,643
Accrued expenses	35,289		46,861
Income taxes payable	—		871
Operating lease liabilities	17,589		16,781




Total current liabilities	70,410		81,156

Operating lease liabilities, net of current portion	31,171		40,207
Other non-current liabilities	101		880


Total liabilities	101,682		122,243
Stockholders’ equity:
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2025 and December 31, 2024	—		—
Common stock, $0.001 par value; 125,000,000 shares authorized; 74,254,956 shares issued and 58,038,545 shares outstanding at June 30, 2025, and 73,372,696 shares issued and 57,156,285 shares outstanding at December 31, 2024	74		73
Additional paid-in capital	2,521,545		2,493,811
Accumulated other comprehensive income (loss)	655		(1,518)
Treasury stock, at cost (16,216,411 shares at June 30, 2025 and December 31, 2024)	(802,486)		(802,486)
Accumulated deficit	(350,233)		(148,924)
Total stockholders’ equity	1,369,555		1,540,956
Total liabilities and stockholders’ equity	$	1,471,237	$	1,663,199

See accompanying Notes to Condensed Consolidated Financial Statements.

Table of Contents

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
(In thousands, except share and per share data)	2025		2024		2025		2024
Revenues:
Product revenue, net	$	12,455	$	8,615	$	21,181	$	16,804


Total revenue	12,455		8,615		21,181		16,804
Operating expenses:
Cost of sales	$	1,702	$	1,495	$	2,787	$	2,122
Research and development	91,940		77,401		164,683		146,021
Selling, general and administrative	45,869		35,536		87,396		66,550
Total operating expenses	139,511		114,432		254,866		214,693
Loss from operations	(127,056)		(105,817)		(233,685)		(197,889)


Interest income, net	14,513		8,120		30,600		17,009
Other income, net	523		1,579		1,776		3,213





Net loss	$	(112,020)	$	(96,118)	$	(201,309)	$	(177,667)


Net loss per share - basic and diluted	$	(1.93)	$	(1.69)	$	(3.49)	$	(3.14)


Weighted-average number of common shares used in computing net loss per share – basic and diluted	57,932,576		56,802,546		57,697,193		56,593,011

See accompanying Notes to Condensed Consolidated Financial Statements.

Table of Contents

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
(In thousands)	2025		2024		2025		2024
Net loss	$	(112,020)	$	(96,118)	$	(201,309)	$	(177,667)
Other comprehensive income (loss)
Unrealized gain (loss) on available-for-sale securities	290		42		2,173		(604)
Comprehensive loss	$	(111,730)	$	(96,076)	$	(199,136)	$	(178,271)

See accompanying Notes to Condensed Consolidated Financial Statements.

Table of Contents

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Stockholders' Equity

(Unaudited)


	Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Treasury Stock			Total Stockholders’ Equity
(in thousands, except share amounts)	Shares	Amount								Shares	Amount
Balance at December 31, 2024	73,372,696	$	73	$	2,493,811	$	(1,518)	$	(148,924)	(16,216,411)	$	(802,486)	$	1,540,956

Unrealized gain on available-for-sale securities	—	—		—		1,883		—		—	—		1,883
Common stock issued under stock incentive plan and ESPP	730,496

SEC Form 10-Q filed by Agios Pharmaceuticals Inc.