agio-20240630

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, 2024


☐			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 26, 2024: 56,893,130

Table of Contents

AGIOS PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2024

TABLE OF CONTENTS


		Page No.
PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of June 30 , 2024 and December 31, 2023	1
	Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30 , 2024 and 2023	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and S ix Months Ended Ju ne 30 , 2024 and 2023	3
	Condensed Consolidated Statements of Stockholders' Equity for the Three and S ix Months Ended June 30 , 2024 and 2023	4
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30 , 2024 and 2023	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	26
Item 4.	Controls and Procedures	26
PART II. OTHER INFORMATION		28
Item 1A.	Risk Factors	28
Item 5.	Other Information	59
Item 6.	Exhibits	60
	Signatures	61

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, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	84,518	$	88,205
Marketable securities	485,374		688,723
Accounts receivable, net	3,762		2,810



Inventory	23,937		19,076
Prepaid expenses and other current assets	34,536		35,021

Total current assets	632,127		833,835
Marketable securities	75,404		29,435
Operating lease assets	48,750		54,409
Property and equipment, net	12,726		15,382
Other non-current assets	4,056		4,057

Total assets	$	773,063	$	937,118
Liabilities and stockholders’ equity
Current liabilities:

Accounts payable	$	10,035	$	9,780
Accrued expenses	36,742		43,167

Operating lease liabilities	15,860		15,008




Total current liabilities	62,637		67,955

Operating lease liabilities, net of current portion	48,760		56,988
Other non-current liabilities	1,156		1,156


Total liabilities	112,553		126,099
Stockholders’ equity:
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2024 and December 31, 2023	—		—
Common stock, $0.001 par value; 125,000,000 shares authorized; 73,091,490 shares issued and 56,875,079 shares outstanding at June 30, 2024, and 72,161,489 shares issued and 55,945,078 shares outstanding at December 31, 2023	73		72
Additional paid-in capital	2,464,284		2,436,523
Accumulated other comprehensive loss	(1,045)		(441)
Treasury stock, at cost (16,216,411 shares at June 30, 2024 and December 31, 2023)	(802,486)		(802,486)
Accumulated deficit	(1,000,316)		(822,649)
Total stockholders’ equity	660,510		811,019
Total liabilities and stockholders’ equity	$	773,063	$	937,118

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)	2024		2023		2024		2023
Revenues:
Product revenue, net	$	8,615	$	6,712	$	16,804	$	12,321


Total revenue	8,615		6,712		16,804		12,321
Operating expenses:
Cost of sales	$	1,495	$	1,108	$	2,122	$	1,662
Research and development	77,401		68,895		146,021		136,196
Selling, general and administrative	35,536		30,409		66,550		58,776
Total operating expenses	114,432		100,412		214,693		196,634
Loss from operations	(105,817)		(93,700)		(197,889)		(184,313)

Interest income, net	8,120		8,254		17,009		16,345
Other income, net	1,579		1,640		3,213		3,144




Net loss	$	(96,118)	$	(83,806)	$	(177,667)	$	(164,824)



Net loss per share - basic and diluted	$	(1.69)	$	(1.51)	$	(3.14)	$	(2.97)

Weighted-average number of common shares used in computing net loss per share – basic and diluted	56,802,546		55,604,330		56,593,011		55,435,796

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)	2024		2023		2024		2023
Net loss	$	(96,118)	$	(83,806)	$	(177,667)	$	(164,824)
Other comprehensive income (loss)
Unrealized gain (loss) on available-for-sale securities	42		(459)		(604)		3,665
Comprehensive loss	$	(96,076)	$	(84,265)	$	(178,271)	$	(161,159)

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 Loss		Accumulated Deficit		Treasury Stock			Total Stockholders’ Equity
(in thousands, except share amounts)	Shares	Amount								Shares	Amount
Balance at December 31, 2023	72,161,489	$	72	$	2,436,523	$	(441)	$	(822,649)	(16,216,411)	$	(802,486)	$	811,019

Unrealized loss on available-for-sale securities	—	—		—		(646)		—		—	—		(646)
Common stock issued under stock incentive plan and ESPP	806,433	1		5,863		—		—		—	—		5,864
Stock-based compensation expense	—	—		9,234		—		—		—	—		9,234

Net loss	—	—

SEC Form 10-Q filed by Agios Pharmaceuticals Inc.