Regeneron Pharmaceuticals, Inc 10-Q for FY2023 Q3

Regeneron Pharmaceuticals, Inc. (REGN)

10-Q 2023-11-02 For: 2023-09-30

Added on April 08, 2026

About this 10-Q

Regeneron Pharmaceuticals, Inc filed this 10-Q on November 2, 2023, covering the quarter ended September 30, 2023 (FY2023 Q3).

Headline figures

Quarter ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $3.36B; up 14.5% from $2.94B a year earlier
Net income: $1.01B; down 23.4% from net income of $1.32B a year earlier
Diluted EPS: $8.89; down 23.8% from $11.66 a year earlier

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(Mark One)
☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
			For the quarterly period ended September 30, 2023
			OR
☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
			For the transition period from __________ to __________


New York						13-3444607
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock - par value $.001 per share	REGN	NASDAQ Global Select Market


Class of Common Stock						Number of Shares
Class A Stock, $.001 par value						1,818,146
Common Stock, $.001 par value						107,128,838


	September 30,		December 31,
	2023		2022
ASSETS
Current assets:
Cash and cash equivalents	$	2,152.3	$	3,105.9
Marketable securities	7,761.3		4,636.4
Accounts receivable, net	5,584.5		5,328.7
Inventories	2,562.0		2,401.9
Prepaid expenses and other current assets	574.7		411.2
Total current assets	18,634.8		15,884.1

Marketable securities	5,778.5		6,591.8
Property, plant, and equipment, net	4,006.1		3,763.0
Intangible assets, net	1,017.2		915.5
Deferred tax assets	2,316.8		1,723.7
Other noncurrent assets	409.9		336.4
Total assets	$	32,163.3	$	29,214.5

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	536.6	$	589.2
Accrued expenses and other current liabilities	2,644.7		2,074.2
Deferred revenue	417.3		477.9
Total current liabilities	3,598.6		3,141.3

Long-term debt	1,982.6		1,981.4
Finance lease liabilities	720.0		720.0
Deferred revenue	125.3		69.8
Other noncurrent liabilities	832.4		638.0
Total liabilities	7,258.9		6,550.5

Stockholders' equity:
Preferred Stock, par value $.01 per share; 30.0 shares authorized; issued and outstanding - none	—		—
Class A Stock, convertible, par value $.001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2023 and 2022	—		—
Common Stock, par value $.001 per share; 320.0 shares authorized; shares issued - 132.1 in 2023 and 130.4 in 2022	0.1		0.1
Additional paid-in capital	11,251.5		9,949.3
Retained earnings	26,100.7		23,306.7
Accumulated other comprehensive loss	(176.8)		(238.8)
Treasury Stock, at cost; 25.1 shares in 2023 and 22.6 shares in 2022	(12,271.1)		(10,353.3)
Total stockholders' equity	24,904.4		22,664.0
Total liabilities and stockholders' equity	$	32,163.3	$	29,214.5

The accompanying notes are an integral part of the financial statements.


777 Old Saw Mill River Road, Tarrytown, New York 10591-6707
(Address of principal executive offices, including zip code)


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.


"Altibodies™," "ARCALYST®," "Evkeeza®," "EYLEA®," "EYLEA® HD," "Inmazeb®," "Libtayo®," "Praluent®" (in the United States), "REGEN-COV®," "Regeneron®," "Regeneron Genetics Center®," "RGC®," "Veloci-Bi®," "VelociGene®," "VelociHum®," "VelociMab®," "VelocImmune®," "VelociMouse®," "VelociSuite®," "VelociT®," "Veopoz™," and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products.


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Statements of Operations
Revenues:
Net product sales	$	1,786.1	$	1,801.4	$	5,226.2	$	5,194.4
Collaboration revenue	1,438.3		1,050.6		4,133.1		3,326.7
Other revenue	138.3		84.2		323.6		237.4
	3,362.7		2,936.2		9,682.9		8,758.5

Expenses:
Research and development	1,075.3		911.3		3,261.8		2,549.4
Acquired in-process research and development	100.0		—		156.1		225.1
Selling, general, and administrative	640.5		529.1		1,893.6		1,455.4
Cost of goods sold	224.5		141.3		625.3		497.8
Cost of collaboration and contract manufacturing	211.9		176.5		673.5		522.0
Other operating (income) expense, net	(0.5)		(45.7)		(1.6)		(83.3)
	2,251.7		1,712.5		6,608.7		5,166.4

Income from operations	1,111.0		1,223.7		3,074.2		3,592.1

Other income (expense):
Other income (expense), net	17.6		301.4		32.2		(16.0)
Interest expense	(17.8)		(15.3)		(54.7)		(42.0)
	(0.2)		286.1		(22.5)		(58.0)

Income before income taxes	1,110.8		1,509.8		3,051.7		3,534.1

Income tax expense	103.0		194.1		257.7		392.8

Net income	$	1,007.8	$	1,315.7	$	2,794.0	$	3,141.3

Net income per share - basic	$	9.48	$	12.31	$	26.16	$	29.30
Net income per share - diluted	$	8.89	$	11.66	$	24.57	$	27.73

Weighted average shares outstanding - basic	106.3		106.9		106.8		107.2
Weighted average shares outstanding - diluted	113.4		112.8		113.7		113.3

Statements of Comprehensive Income
Net income	$	1,007.8	$	1,315.7	$	2,794.0	$	3,141.3
Other comprehensive income (loss), net of tax:
Unrealized gain (loss) on debt securities	21.3		(51.3)		62.8		(249.9)
Loss on foreign currency translation	(0.4)		—		(0.8)		—
Unrealized gain on cash flow hedges	—		—		—		1.0
Comprehensive income	$	1,028.7	$	1,264.4	$	2,856.0	$	2,892.4

The accompanying notes are an integral part of the financial statements.


	Class A Stock			Common Stock			Additional Paid-in Capital		Retained Earnings		Accumulated Other Comprehensive Income (Loss)		Treasury Stock			Total Stockholders' Equity
	Shares	Amount		Shares	Amount								Shares	Amount
Balance, December 31, 2022	1.8	$	—	130.4	$	0.1	$	9,949.3	$	23,306.7	$	(238.8)	(22.6)	$	(10,353.3)	$	22,664.0
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		1.1	—		491.3		—		—		—	—		491.3
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.1)	—		(99.2)		—		—		—	—		(99.2)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		18.9		—		—		—	1.7		20.6
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.9)	(693.9)		(693.9)
Stock-based compensation charges	—	—		—	—		237.4		—		—		—	—		237.4
Net income	—	—		—	—		—		817.8		—		—	—		817.8
Other comprehensive income, net of tax	—	—		—	—		—		—		57.2		—	—		57.2
Balance, March 31, 2023	1.8	—		131.4	0.1		10,597.7		24,124.5		(181.6)		(23.5)	(11,045.5)		23,495.2
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		0.2	—		80.7		—		—		—	—		80.7
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		—	—		(14.0)		—		—		—	—		(14.0)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		16.1		—		—		—	2.4		18.5
Repurchases of Common Stock	—	—		—	—		—		—		—		(1.0)	(722.8)		(722.8)
Stock-based compensation charges	—	—		—	—		208.0		—		—		—	—		208.0
Net income	—	—		—	—		—		968.4		—		—	—		968.4
Other comprehensive loss, net of tax	—	—		—	—		—		—		(16.1)		—	—		(16.1)
Balance, June 30, 2023	1.8	—		131.6	0.1		10,888.5		25,092.9		(197.7)		(24.5)	(11,765.9)		24,017.9
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		0.7	—		268.9		—		—		—	—		268.9
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.2)	—		(129.4)		—		—		—	—		(129.4)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		16.1		—		—		—	1.9		18.0
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.6)	(507.1)		(507.1)
Stock-based compensation charges	—	—		—	—		207.4		—		—		—	—		207.4
Net income	—	—		—	—		—		1,007.8		—		—	—		1,007.8
Other comprehensive income, net of tax	—	—		—	—		—		—		20.9		—	—		20.9
Balance, September 30, 2023	1.8	$	—	132.1	$	0.1	$	11,251.5	$	26,100.7	$	(176.8)	(25.1)	$	(12,271.1)	$	24,904.4


CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)
	Class A Stock			Common Stock			Additional Paid-in Capital		Retained Earnings		Accumulated Other Comprehensive Income (Loss)		Treasury Stock			Total Stockholders' Equity
	Shares	Amount		Shares	Amount								Shares	Amount
Balance, December 31, 2021	1.8	$	—	126.2	$	0.1	$	8,087.5	$	18,968.3	$	(26.2)	(19.4)	$	(8,260.9)	$	18,768.8
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		1.6	—		593.7		—		—		—	—		593.7
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.2)	—		(105.8)		—		—		—	—		(105.8)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		12.8		—		—		—	1.7		14.5
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.5)	(352.0)		(352.0)
Stock-based compensation charges	—	—		—	—		165.9		—		—		—	—		165.9
Net income	—	—		—	—		—		973.5		—		—	—		973.5
Other comprehensive loss, net of tax	—	—		—	—		—		—		(143.9)		—	—		(143.9)
Balance, March 31, 2022	1.8	—		127.6	0.1		8,754.1		19,941.8		(170.1)		(19.9)	(8,611.2)		19,914.7
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		0.8	—		228.0		—		—		—	—		228.0
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.1)	—		(41.9)		—		—		—	—		(41.9)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		14.0		—		—		—	2.2		16.2
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.7)	(393.6)		(393.6)
Stock-based compensation charges	—	—		—	—		166.0		—		—		—	—		166.0
Net income	—	—		—	—		—		852.1		—		—	—		852.1
Other comprehensive loss, net of tax	—	—		—	—		—		—		(53.7)		—	—		(53.7)
Balance, June 30, 2022	1.8	—		128.3	0.1		9,120.2		20,793.9		(223.8)		(20.6)	(9,002.6)		20,687.8
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		0.9	—		322.9		—		—		—	—		322.9
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.2)	—		(108.9)		—		—		—	—		(108.9)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		12.9		—		—		—	1.6		14.5
Repurchases of Common Stock	—	—		—	—		—		—		—		(1.4)	(913.0)		(913.0)
Stock-based compensation charges	—	—		—	—		171.1		—		—		—	—		171.1
Net income	—	—		—	—		—		1,315.7		—		—	—		1,315.7
Other comprehensive loss, net of tax	—	—		—	—		—		—		(51.3)		—	—		(51.3)
Balance, September 30, 2022	1.8	$	—	129.0	$	0.1	$	9,518.2	$	22,109.6	$	(275.1)	(22.0)	$	(9,914.0)	$	21,438.8

The accompanying notes are an integral part of the financial statements.


		Three Months Ended September 30,				Nine Months Ended September 30,
(In millions)		2023		2022		2023		2022
EYLEA®	U.S.	$	1,448.2	$	1,629.4	$	4,382.1	$	4,768.2
EYLEA HD	U.S.	42.7		—		42.7		—
Libtayo®(a)	U.S.	144.1		94.7		384.0		264.5
Libtayo(a)	ROW(b)	88.3		31.0		235.3		31.0
Praluent®	U.S.	40.4		29.7		121.1		94.5
Evkeeza®	U.S.	19.1		13.6		53.3		33.2
Inmazeb®	U.S.	3.3		3.0		7.7		3.0
		$	1,786.1	$	1,801.4	$	5,226.2	$	5,194.4

(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective July 1, 2022, the Company records global net product sales of Libtayo. See Note 3 for further details.
(b) Rest of world ("ROW")


	Statement of Operations Classification	Three Months Ended September 30,					Nine Months Ended September 30,
(In millions)		2023		2022			2023		2022
Antibody:
Regeneron's share of profits in connection with commercialization of antibodies	Collaboration revenue	$	863.0	$	551.1	*	$	2,250.6	$	1,463.0	*
Sales-based milestones earned	Collaboration revenue	$	50.0	$	—		$	50.0	$	50.0
Reimbursement for manufacturing of commercial supplies	Collaboration revenue	$	151.5	$	160.5		$	506.0	$	466.8
Other	Collaboration revenue	$	—	$	(0.2)		$	—	$	28.7
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses	(R&D expense)/Reduction of R&D expense	$	(25.8)	$	(4.3)		$	(66.7)	$	59.6
Reimbursement of commercialization-related expenses	Reduction of SG&A expense	$	135.5	$	108.6		$	384.0	$	311.1

Immuno-oncology(a):
Regeneron's share of profits in connection with commercialization of Libtayo outside the United States	Collaboration revenue	$	—	$	—		$	—	$	6.7
Reimbursement for manufacturing of ex-U.S. commercial supplies	Collaboration revenue	$	—	$	—		$	—	$	4.6
Reimbursement of R&D expenses	Reduction of R&D expense	$	—	$	—		$	—	$	42.7
Reimbursement of commercialization-related expenses	Reduction of SG&A expense	$	—	$	—		$	—	$	41.4
Regeneron's obligation for its share of Sanofi commercial expenses	SG&A expense	$	—	$	—		$	—	$	(19.9)
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits	Cost of goods sold	$	—	$	—		$	—	$	(70.1)
Amounts recognized in connection with up-front payments received	Other operating income	$	—	$	—		$	—	$	35.1

* Net of one-time payment of $56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement described below
(a) As described within the "Immuno-Oncology" section below, effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.


	September 25,
(In millions)	2023
Cash and cash equivalents	$	42.2
Marketable securities	12.1
Deferred tax assets, net	58.1
Indefinite-lived intangible asset related to in-process research and development	42.5
Goodwill	5.2
Other assets and liabilities, net	(11.4)
	$	148.7


	Three Months Ended September 30,				Nine Months Ended September 30,
(In millions, except per share data)	2023		2022		2023		2022
Net income - basic and diluted	$	1,007.8	$	1,315.7	$	2,794.0	$	3,141.3

Weighted average shares - basic	106.3		106.9		106.8		107.2
Effect of dilutive securities:
Stock options	4.8		4.3		4.9		4.7
Restricted stock awards and restricted stock units	2.3		1.6		2.0		1.4
Weighted average shares - diluted	113.4		112.8		113.7		113.3

Net income per share - basic	$	9.48	$	12.31	$	26.16	$	29.30
Net income per share - diluted	$	8.89	$	11.66	$	24.57	$	27.73


			Commission File Number: 000-19034


(In millions)	Amortized		Unrealized				Fair
As of September 30, 2023	Cost Basis		Gains		Losses		Value
Corporate bonds	$	6,726.3	$	0.4	$	(189.1)	$	6,537.6
U.S. government and government agency obligations	5,112.6		0.2		(30.5)		5,082.3
Sovereign bonds	67.3		—		(1.7)		65.6
Commercial paper	505.1		0.2		(0.2)		505.1
Certificates of deposit	342.6		0.1		(0.1)		342.6
Asset-backed securities	89.6		—		(2.4)		87.2
	$	12,843.5	$	0.9	$	(224.0)	$	12,620.4

As of December 31, 2022
Corporate bonds	$	6,975.5	$	—	$	(291.1)	$	6,684.4
U.S. government and government agency obligations	2,945.4		0.9		(6.9)		2,939.4
Sovereign bonds	67.1		—		(3.0)		64.1
Commercial paper	121.1		—		—		121.1
Certificates of deposit	182.1		—		(0.1)		182.0
Asset-backed securities	28.9		—		(1.7)		27.2
	$	10,320.1	$	0.9	$	(302.8)	$	10,018.2


	September 30,		December 31,
(In millions)	2023		2022
Maturities within one year	$	7,786.0	$	4,636.4
Maturities after one year through five years	4,830.0		5,381.4
Maturities after five years	4.4		0.4
	$	12,620.4	$	10,018.2


	Less than 12 Months				12 Months or Greater				Total
(In millions) As of September 30, 2023	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss
Corporate bonds	$	1,976.1	$	(23.8)	$	4,387.1	$	(165.3)	$	6,363.2	$	(189.1)
U.S. government and government agency obligations	2,794.8		(26.8)		51.7		(3.7)		2,846.5		(30.5)
Sovereign bonds	12.2		(0.2)		53.3		(1.5)		65.5		(1.7)
Commercial paper	431.8		(0.2)		—		—		431.8		(0.2)
Certificates of deposit	136.3		(0.1)		—		—		136.3		(0.1)
Asset-backed securities	62.3		(1.1)		24.9		(1.3)		87.2		(2.4)
	$	5,413.5	$	(52.2)	$	4,517.0	$	(171.8)	$	9,930.5	$	(224.0)

As of December 31, 2022
Corporate bonds	$	2,445.4	$	(73.1)	$	4,200.4	$	(218.0)	$	6,645.8	$	(291.1)
U.S. government and government agency obligations	785.2		(2.0)		71.0		(4.9)		856.2		(6.9)
Sovereign bonds	18.6		(1.1)		45.6		(1.9)		64.2		(3.0)
Certificates of deposit	40.2		(0.1)		—		—		40.2		(0.1)
Asset-backed securities	11.5		(0.6)		15.2		(1.1)		26.7		(1.7)
	$	3,300.9	$	(76.9)	$	4,332.2	$	(225.9)	$	7,633.1	$	(302.8)


	Three Months Ended September 30,		Nine Months Ended September 30,
(Shares in millions)	2023	2022	2023	2022
Stock options	1.7	2.4	1.7	2.3


(In millions)			Fair Value Measurements at Reporting Date
As of September 30, 2023	Fair Value		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	1,018.5	$	119.9	$	898.6	$	—
Available-for-sale debt securities:
Corporate bonds	6,537.6		—		6,537.6		—
U.S. government and government agency obligations	5,082.3		—		5,082.3		—
Sovereign bonds	65.6		—		65.6		—
Commercial paper	505.1		—		505.1		—
Certificates of deposit	342.6		—		342.6		—
Asset-backed securities	87.2		—		87.2		—
Equity securities (unrestricted)	802.3		802.3		—		—
Equity securities (restricted)	117.1		117.1		—		—
Total assets	$	14,558.3	$	1,039.3	$	13,519.0	$	—

Liabilities:
Contingent consideration - CVRs	$	43.7	$	—	$	—	$	43.7

As of December 31, 2022
Assets:
Cash equivalents	$	1,662.8	$	88.3	$	1,574.5	$	—
Available-for-sale debt securities:
Corporate bonds	6,684.4		—		6,684.4		—
U.S. government and government agency obligations	2,939.4		—		2,939.4		—
Sovereign bonds	64.1		—		64.1		—
Commercial paper	121.1		—		121.1		—
Certificates of deposit	182.0		—		182.0		—
Asset-backed securities	27.2		—		27.2		—
Equity securities (unrestricted)	24.6		24.6		—		—
Equity securities (restricted)	1,185.4		1,185.4		—		—
Total assets	$	12,891.0	$	1,298.3	$	11,592.7	$	—


	Three Months Ended September 30,						Nine Months Ended September 30,
(In millions, except headcount data)	2023		2022		Change		2023		2022		Change
Research and development(a)	$	1,075.3	$	911.3	$	164.0	$	3,261.8	$	2,549.4	$	712.4
Acquired in-process research and development	100.0		—		100.0		156.1		225.1		(69.0)
Selling, general, and administrative(a)	640.5		529.1		111.4		1,893.6		1,455.4		438.2
Cost of goods sold	224.5		141.3		83.2		625.3		497.8		127.5
Cost of collaboration and contract manufacturing(b)	211.9		176.5		35.4		673.5		522.0		151.5
Other operating (income) expense, net	(0.5)		(45.7)		45.2		(1.6)		(83.3)		81.7
Total operating expenses	$	2,251.7	$	1,712.5	$	539.2	$	6,608.7	$	5,166.4	$	1,442.3

Average headcount	12,878		11,316		1,562		12,463		10,915		1,548

(a) Includes costs incurred net of any cost reimbursements from collaborators who are not deemed to be our customers
(b) Includes costs incurred in connection with producing commercial drug supplies for collaborators and others


	Three Months Ended September 30,						Nine Months Ended September 30,
(In millions, except effective tax rate)	2023			2022			2023			2022
Income tax expense	$	103.0		$	194.1		$	257.7		$	392.8
Effective tax rate	9.3		%	12.9		%	8.4		%	11.1		%


Period	Total Number of Shares Purchased		Average Price Paid per Share		Total Number of Shares Purchased as Part of Publicly Announced Programs		Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (In millions)
7/1/2023–7/31/2023	525,523		$	721.95	525,523		$	1,952.9
8/1/2023–8/31/2023	161,175		$	788.78	161,175		$	1,825.8
9/1/2023–9/30/2023	3,221		$	832.50	—		$	1,825.8
Total	689,919	(a)			686,698	(a)

(a) The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans.


Exhibit Number						Description
31.1						Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
31.2						Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
32						Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
101						Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022; (ii) the Registrant's Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2023 and 2022; (iii) the Registrant's Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2023 and 2022; (iv) the Registrant's Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022; and (v) the notes to the Registrant's Condensed Consolidated Financial Statements.
104						Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).


Date:	November 2, 2023	/s/ Leonard S. Schleifer
		Leonard S. Schleifer, M.D., Ph.D.
		President and Chief Executive Officer
		(Principal Executive Officer)


Date:	November 2, 2023	/s/ Robert E. Landry
		Robert E. Landry
		Executive Vice President, Finance and Chief Financial Officer
		(Principal Financial Officer)