agio-20230630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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, 2023


☐			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 28, 2023: 55,739,306

Table of Contents

AGIOS PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023

TABLE OF CONTENTS


		Page No.
PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of June 30 , 2023 and December 31, 2022	1
	Condensed Consolidated Statements of Operations for the Three and S i x Months Ended June 30 , 2023 and 2022	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30 , 2023 and 2022	3
	Condensed Consolidated Statements of Stockholders' Equity for the Three and Six Months Ended June 30 , 2023 and 2022	4
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30 , 2023 and 2022	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	25
Item 4.	Controls and Procedures	25
PART II. OTHER INFORMATION		27
Item 1A.	Risk Factors	27
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, 2023		December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	84,753	$	139,259
Marketable securities	617,813		643,860
Accounts receivable, net	2,251		2,206



Inventory	15,671		8,492
Prepaid expenses and other current assets	36,751		38,955

Total current assets	757,239		832,772
Marketable securities	244,357		313,874
Operating lease assets	59,866		65,129
Property and equipment, net	19,634		22,987
Other non-current assets	4,057		3,956

Total assets	$	1,085,153	$	1,238,718
Liabilities and stockholders’ equity
Current liabilities:

Accounts payable	$	11,626	$	18,616
Accrued expenses	29,189		30,350

Operating lease liabilities	14,326		13,663




Total current liabilities	55,141		62,629

Operating lease liabilities, net of current portion	64,620		71,996
Other non-current liabilities	1,156		3,279


Total liabilities	120,917		137,904
Stockholders’ equity:
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2023 and December 31, 2022	—		—
Common stock, $0.001 par value; 125,000,000 shares authorized; 71,951,186 shares issued and 55,734,775 shares outstanding at June 30, 2023, and 71,256,118 shares issued and 55,039,707 shares outstanding at December 31, 2022	72		71
Additional paid-in capital	2,410,905		2,386,325
Accumulated other comprehensive loss	(8,870)		(12,535)
Treasury stock, at cost (16,216,411 shares at June 30, 2023 and December 31, 2022)	(802,486)		(802,486)
Accumulated deficit	(635,385)		(470,561)
Total stockholders’ equity	964,236		1,100,814
Total liabilities and stockholders’ equity	$	1,085,153	$	1,238,718

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)	2023		2022		2023		2022
Revenues:
Product revenue, net	$	6,712	$	3,082	$	12,321	$	3,914
Milestone revenue	—		2,500		—		2,500

Total revenue	6,712		5,582		12,321		6,414
Operating expenses:
Cost of sales	$	1,108	$	435	$	1,662	$	774
Research and development	68,895		74,523		136,196		144,646
Selling, general and administrative	30,409		28,264		58,776		59,779
Total operating expenses	100,412		103,222		196,634		205,199
Loss from operations	(93,700)		(97,640)		(184,313)		(198,785)
Royalty income from gain on sale of oncology business	—		2,704		—		5,408
Interest income, net	8,254		1,793		16,345		2,487
Other income, net	1,640		1,337		3,144		4,310




Net loss	$	(83,806)	$	(91,806)	$	(164,824)	$	(186,580)



Net loss per share - basic and diluted	$	(1.51)	$	(1.68)	$	(2.97)	$	(3.41)

Weighted-average number of common shares used in computing net loss per share – basic and diluted	55,604,330		54,799,680		55,435,796		54,678,249

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)	2023		2022		2023		2022
Net loss	$	(83,806)	$	(91,806)	$	(164,824)	$	(186,580)
Other comprehensive (loss) income
Unrealized (loss) gain on available-for-sale securities	(459)		(2,757)		3,665		(9,304)
Comprehensive loss	$	(84,265)	$	(94,563)	$	(161,159)	$	(195,884)

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) Income		Accumulated Deficit		Treasury Stock			Total Stockholders’ Equity
(in thousands, except share amounts)	Shares	Amount								Shares	Amount
Balance at December 31, 2022	71,256,118	$	71	$	2,386,325	$	(12,535)	$	(470,561)	(16,216,411)	$	(802,486)	$	1,100,814

Unrealized gain on available-for-sale securities	—	—		—		4,124		—		—	—		4,124

SEC Form 10-Q filed by Agios Pharmaceuticals Inc.