Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

_______________________________________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15 (d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 21, 2024

United Therapeutics Corporation

(Exact Name of Registrant as Specified in Charter)


Delaware	000-26301	52-1984749
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)


1000 Spring Street
Silver Spring,
MD			20910
(Address of Principal Executive Offices)			(Zip Code)

Registrant’s telephone number, including area code:

(301) 608-9292

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


Title of each class	Trading Symbol(s)	Name of exchange on which registered
Common Stock, par value $0.01 per share	UTHR	Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02. Results of Operations and Financial Condition.

On February 21, 2024, United Therapeutics Corporation (the Company) issued a press release setting forth its earnings and business updates for the quarter and year ended December 31, 2023.

A copy of the press release is attached hereto as Exhibit 99.1.

Item 7.01. Regulation FD Disclosure.

On February 21, 2024, the Company issued a press release announcing that it had filed a lawsuit against the U.S. Food and Drug Administration (FDA) related to the amendment filed by Liquidia Technologies, Inc., to its pending New Drug Application for its inhaled treprostinil product, seeking to add an indication for pulmonary hypertension associated with interstitial lung disease.

A copy of the press release is attached as Exhibit 99.2.

Item 9.01. Exhibits

This information shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

(d) Exhibits


Exhibit No.						Description of Exhibit

99.1						Press Release dated February 2 1 , 202 4 , related to the Company's fourth qua rter and full year 202 3 earnings .
99.2						Press Release dated February 21, 2024, related to the Company's lawsuit against the FDA.
104						The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	UNITED THERAPEUTICS CORPORATION


Dated: February 21, 2024	By:	/s/ Paul A. Mahon
	Name:	Paul A. Mahon
	Title:	General Counsel

Exhibit 99.1

For Immediate Release

United Therapeutics Corporation Reports Fourth Quarter and Full Year 2023 Financial Results

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., February 21, 2024: United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter and year ended December 31, 2023. Full year 2023 revenues rose to a record $2.33 billion, reflecting 20% growth over 2022.

“Congratulations to the dedicated Unitherians who worked tirelessly to help us achieve our third straight quarter and second straight year of record revenue,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “This represents only the beginning of our growth, driven by a strong foundation in our current commercial business and upcoming enrollment milestones for our innovative pipeline. On top of this, we have continued momentum for our revolutionary organ manufacturing programs, with the first human clinical study of a bioengineered organ, the miroliverELAP, cleared by the FDA, and the recent opening of the world’s first designated pathogen-free clinical supply facility to support our upcoming xenotransplantation clinical program.”

“Our commercial business remains a solid foundation supporting our innovative and revolutionary efforts to cure end stage organ disease,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “To that end, in the fourth quarter we saw record revenue for our Tyvaso business, and we achieved solid growth in our U.S. Remodulin business, with strong revenue growth and a record number of patients on therapy despite the presence of generic competition since 2019.”

Fourth Quarter and Full Year 2023 Financial Results

Key financial highlights include (in millions, except per share data):


	Three Months Ended December 31,				Year Ended December 31,
	2023		2022		2023		2022

Total revenues	$	614.7	$	491.5	$	2,327.5	$	1,936.3
Net income	$	217.1	$	132.1	$	984.8	$	727.3
Net income, per basic share	$	4.62	$	2.88	$	21.04	$	15.98
Net income, per diluted share	$	4.36	$	2.67	$	19.81	$	15.00


						1

Revenues

The table below presents the components of total revenues (dollars in millions):


	Three Months Ended December 31,				Dollar Change		Percentage Change		Year Ended December 31,				Dollar Change		Percentage Change
	2023		2022						2023		2022
Net product sales:
Tyvaso DPI®(1)	$	213.7	$	92.2	$	121.5	132	%	$	731.1	$	158.3	$	572.8	362	%
Nebulized Tyvaso®(1)	136.9		150.1		(13.2)		(9)	%	502.6		714.7		(212.1)		(30)	%
Total Tyvaso	350.6		242.3		108.3		45	%	1,233.7		873.0		360.7		41	%
Remodulin®(2)	115.1		122.5		(7.4)		(6)	%	494.8		500.2		(5.4)		(1)	%
Orenitram®	84.1		75.8		8.3		11	%	359.4		325.1		34.3		11	%
Unituxin®	54.2		36.7		17.5		48	%	198.9		182.9		16.0		9	%
Adcirca®	6.8		10.4		(3.6)		(35)	%	28.9		41.3		(12.4)		(30)	%
Other	3.9		3.8		0.1		3	%	11.8		13.8		(2.0)		(14)	%
Total revenues	$	614.7	$	491.5	$	123.2	25	%	$	2,327.5	$	1,936.3	$	391.2	20	%

(1)Net product sales include both the drug product and the respective inhalation device.

(2)Net product sales include sales of infusion devices including the Remunity® Pump.

Fourth Quarter 2023 Compared to Fourth Quarter 2022. Total Tyvaso revenues grew by 45% to $350.6 million in the fourth quarter of 2023, compared to $242.3 million in the fourth quarter of 2022. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold. The decrease in nebulized Tyvaso revenues was primarily due to a decrease in U.S. quantities sold following the commercial launch of Tyvaso DPI, partially offset by an increase in international nebulized Tyvaso revenues, primarily due to the commercial launch of nebulized Tyvaso in Japan in December 2022, as shown in the table below. The decrease in Remodulin revenues resulted from a decrease in international Remodulin revenues, partially offset by an increase in U.S. Remodulin revenues, as shown in the table below. The increase in Orenitram revenues resulted from a price increase and an increase in quantities sold. The increase in Unituxin revenues resulted from an increase in quantities sold and a price increase.

Full Year 2023 Compared to Full Year 2022. Total Tyvaso revenues grew by 41% to $1,233.7 million in 2023, compared to $873.0 million in 2022. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in utilization by patients with PH-ILD. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold. The decrease in nebulized Tyvaso revenues was driven by a decrease in U.S. nebulized Tyvaso revenues, primarily due to a decrease in quantities sold following the commercial launch of Tyvaso DPI, partially offset by an increase in international nebulized Tyvaso revenues, primarily due to the commercial launch of nebulized Tyvaso in Japan in December 2022, as shown in the table below. The decrease in Remodulin revenues resulted from a decrease in international Remodulin revenues, partially offset by an increase in U.S. Remodulin revenues, as shown in the table below. The increase in Orenitram revenues resulted from a price increase and an increase in quantities sold. The increase in Unituxin revenues resulted primarily from a price increase.


						2

The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions):


	Three Months Ended December 31,												Year Ended December 31,
	2023						2022						2023						2022
	U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total
Net product sales:
Tyvaso DPI(1)	$	213.7	$	—	$	213.7	$	92.2	$	—	$	92.2	$	731.1	$	—	$	731.1	$	158.3	$	—	$	158.3
Nebulized Tyvaso(1)	123.7		13.2		136.9		148.4		1.7		150.1		477.1		25.5		502.6		708.6		6.1		714.7
Total Tyvaso	337.4		13.2		350.6		240.6		1.7		242.3		1,208.2		25.5		1,233.7		866.9		6.1		873.0
Remodulin(2)	106.3		8.8		115.1		97.7		24.8		122.5		414.6		80.2		494.8		407.5		92.7		500.2
Orenitram	84.1		—		84.1		75.8		—		75.8		359.4		—		359.4		325.1		—		325.1
Unituxin	48.7		5.5		54.2		36.4		0.3		36.7		181.3		17.6		198.9		170.5		12.4		182.9
Adcirca	6.8		—		6.8		10.4		—		10.4		28.9		—		28.9		41.3		—		41.3
Other	2.6		1.3		3.9		2.8		1.0		3.8		9.8		2.0		11.8		2.8		11.0		13.8
Total revenues	$	585.9	$	28.8	$	614.7	$	463.7	$	27.8	$	491.5	$	2,202.2	$	125.3	$	2,327.5	$	1,814.1	$	122.2	$	1,936.3

(1) Net product sales include both the drug product and the respective inhalation device.

(2) Net product sales include sales of infusion devices including the Remunity Pump.

Expenses

Cost of sales. The table below summarizes cost of sales by major category (dollars in millions):


	Three Months Ended December 31,				Dollar Change		Percentage Change		Year Ended December 31,				Dollar Change		Percentage Change
	2023		2022						2023		2022
Category:
Cost of sales	$	70.1	$	55.9	$	14.2	25	%	$	255.1	$	146.7	$	108.4	74	%
Share-based compensation expense(1)	0.9		2.9		(2.0)		(69)	%	2.4		4.9		(2.5)		(51)	%
Total cost of sales	$	71.0	$	58.8	$	12.2	21	%	$	257.5	$	151.6	$	105.9	70	%

(1)See Share-based compensation below.

Cost of sales, excluding share-based compensation. The increase in cost of sales for the quarter ended December 31, 2023, as compared to the same period in 2022, was primarily due to an increase in Tyvaso DPI royalty expense and product costs following its commercial launch in June 2022.

The increase in cost of sales for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to an increase in Tyvaso DPI royalty expense and product costs, following its commercial launch in June 2022, and an increase in Remunity product sales.


						3

Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):


	Three Months Ended December 31,				Dollar Change		Percentage Change		Year Ended December 31,				Dollar Change		Percentage Change
	2023		2022						2023		2022
Category:
External research and development(1)	$	50.4	$	46.7	$	3.7	8	%	$	192.0	$	168.8	$	23.2	14	%
Internal research and development(2)	43.2		35.4		7.8		22	%	146.6		131.4		15.2		12	%
Share-based compensation expense(3)	5.7		11.0		(5.3)		(48)	%	15.6		23.8		(8.2)		(34)	%
Impairments(4)	—		—		—		—	%	—		—		—		—	%
Other(5)	52.1		0.8		51.3		NM(6)		53.8		(1.1)		54.9		NM(6)
Total research and development expense	$	151.4	$	93.9	$	57.5	61	%	$	408.0	$	322.9	$	85.1	26	%

(1)External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product.

(2)Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities.

(3)See Share-based compensation below.

(4)Impairments primarily includes impairment charges to write down the carrying value of in-process research and development (IPR&D) and of certain property, plant, and equipment as a result of research and development activities. There were no impairment charges during the years ended December 31, 2023 and December 31, 2022.

(5)Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, and costs to acquire certain IPR&D assets. During the quarter and year ended December 31, 2023, we recorded $46.0 million in IPR&D expense in connection with the acquisition of IVIVA Medical, Inc. (IVIVA).

(6)Calculation is not meaningful.

Research and development, excluding share-based compensation. The increase in research and development expense for the quarter ended December 31, 2023, as compared to the same period in 2022, was due to an increase in IPR&D expense in connection with the acquisition of IVIVA and increased expenditures related to the TETON 1 and TETON 2 clinical studies of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (IPF).

The increase in research and development expense for the year ended December 31, 2023, as compared to the same period in 2022, was due to: (1) an increase in IPR&D expense in connection with the acquisition of IVIVA; (2) increased expenditures related to the TETON 1 and TETON 2 clinical studies of nebulized Tyvaso in patients with IPF; and (3) increased expenditures related to organ manufacturing projects.


						4

Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):


	Three Months Ended December 31,				Dollar Change		Percentage Change		Year Ended December 31,				Dollar Change		Percentage Change
	2023		2022						2023		2022
Category:
General and administrative	$	98.1	$	89.3	$	8.8	10	%	$	374.2	$	333.2	$	41.0	12	%
Sales and marketing	24.1		23.0		1.1		5	%	81.8		70.8		11.0		16	%
Share-based compensation expense(1)	10.0		50.9		(40.9)		(80)	%	21.1		78.1		(57.0)		(73)	%
Total selling, general, and administrative expense	$	132.2	$	163.2	$	(31.0)	(19)	%	$	477.1	$	482.1	$	(5.0)	(1)	%

(1)See Share-based compensation below.

General and administrative, excluding share-based compensation. The increase in general and administrative expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to increases in: (1) office expenses; (2) personnel expense due to growth in headcount; and (3) sponsorships and grants.

Sales and marketing, excluding share-based compensation. The increase in sales and marketing expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) consulting expenses.

Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):


	Three Months Ended December 31,				Dollar Change		Percentage Change		Year Ended December 31,				Dollar Change		Percentage Change
	2023		2022						2023		2022
Category:
Stock options	$	2.9	$	5.8	$	(2.9)	(50)	%	$	15.4	$	22.6	$	(7.2)	(32)	%
Restricted stock units	14.1		12.1		2.0		17	%	52.4		35.7		16.7		47	%
Share tracking awards plan (STAP)	(0.9)		46.5		(47.4)		(102)	%	(30.7)		46.7		(77.4)		(166)	%

Employee stock purchase plan	0.5		0.4		0.1		25	%	2.0		1.8		0.2		11	%
Total share-based compensation expense	$	16.6	$	64.8	$	(48.2)	(74)	%	$	39.1	$	106.8	$	(67.7)	(63)	%

The decrease in share-based compensation expense for the quarter ended December 31, 2023, as compared to the same period in 2022, was primarily due to an increase in STAP benefit driven by a three percent decrease in our stock price during the quarter ended December 31, 2023, as compared to a 33 percent increase in our stock price for the same period in 2022. The decrease in share-based compensation expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to: (1) an increase in STAP benefit driven by a 21 percent decrease in our stock price during 2023, as compared to a 29 percent increase in our stock price during 2022; and (2) a decrease in stock option expense due to fewer awards remaining outstanding in 2023, as compared to the same period in 2022, partially offset by an increase in restricted stock unit expense.

Other expense, net. The change in other expense, net for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to net unrealized and realized gains and losses on equity securities.

Income tax expense. Income tax expense was $289.5 million for the year ended December 31, 2023, compared to $223.3 million for the same period in 2022. Our effective income tax rate was approximately 23 percent for the years ended December 31, 2023 and 2022.


						5

Inducement Restricted Stock Units

On February 19, 2024, we granted a total of 11,250 restricted stock units under our 2019 Inducement Stock Incentive Plan to six newly hired employees. All of these restricted stock units will vest in full on February 19, 2027, the third anniversary of the grant date, assuming continued employment on such date, and subject to the standard terms and conditions we filed with the SEC as Exhibit 10.2 to our Current Report on Form 8-K on March 1, 2019. We are providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

Webcast

We will host a webcast to discuss our fourth quarter and full year 2023 financial results on Wednesday, February 21, 2024, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations/default.aspx. A replay of the webcast will also be available at the same location on our website.

United Therapeutics: Enabling Inspiration

At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.

You can learn more about what it means to be a PBC here: unither.com/pbc.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our future growth expectations from both our current commercial operations and our pipeline; our organ manufacturing programs, including our efforts to cure end-stage organ disease and the anticipated clinical trials of miroliverELAP and our xenotransplantation program; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of February 21, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.

MIROLIVERELAP, ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.

ADCIRCA is a registered trademark of Eli Lilly and Company.

For Further Information Contact:

Dewey Steadman at (202) 919-4097

https://ir.unither.com/contact-ir


						6

UNITED THERAPEUTICS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In millions, except per share data)


	Three Months Ended December 31,				Year Ended December 31,
	2023		2022		2023		2022



	(Unaudited)
Total revenues	$	614.7	$	491.5	$	2,327.5	$	1,936.3
Operating expenses:
Cost of sales	71.0		58.8		257.5		151.6
Research and development	151.4		93.9		408.0		322.9
Selling, general, and administrative	132.2		163.2		477.1		482.1

Total operating expenses	354.6		315.9		1,142.6		956.6
Operating income	260.1		175.6		1,184.9		979.7

Interest income	51.0		20.8		162.7		45.2
Interest expense	(15.1)		(12.3)		(59.3)		(32.4)
Other expense, net	(0.6)		(5.3)		(14.0)		(40.2)
Impairment of investment in privately-held company	—		—		—		(1.7)
Total other income (expense), net	35.3		3.2		89.4		(29.1)
Income before income taxes	295.4		178.8		1,274.3		950.6
Income tax expense	(78.3)		(46.7)		(289.5)		(223.3)
Net income	$	217.1	$	132.1	$	984.8	$	727.3
Net income per common share:
Basic	$	4.62	$	2.88	$	21.04	$	15.98
Diluted	$	4.36	$	2.67	$	19.81	$	15.00
Weighted average number of common shares outstanding:
Basic	47.0		45.8		46.8		45.5
Diluted	49.8		49.4		49.7		48.5

SELECTED CONSOLIDATED BALANCE SHEET DATA

(In millions)


	December 31,
	2023		2022
Cash, cash equivalents, and marketable investments	$	4,903.9	$	4,154.9
Total assets	7,167.0		6,044.5
Total liabilities	1,182.2		1,247.8
Total stockholders' equity	5,984.8		4,796.7


						7

The table below presents the breakdown of select historical total revenues between the United States and ROW (in millions):


	Three Months Ended
	March 31, 2023						June 30, 2023						September 30, 2023						December 31, 2023
	U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total
Net product sales:
Tyvaso DPI(1)	$	118.7	$	—	$	118.7	$	193.6	$	—	$	193.6	$	205.1	$	—	$	205.1	$	213.7	$	—	$	213.7
Nebulized Tyvaso(1)	115.7		4.0		119.7		119.6		5.7		125.3		118.1		2.6		120.7		123.7		13.2		136.9
Total Tyvaso	234.4		4.0		238.4		313.2		5.7		318.9		323.2		2.6		325.8		337.4		13.2		350.6
Remodulin(2)	93.2		28.2		121.4		103.5		23.7		127.2		111.6		19.5		131.1		106.3		8.8		115.1
Orenitram	88.2		—		88.2		95.1		—		95.1		92.0		—		92.0		84.1		—		84.1
Unituxin	44.3		4.8		49.1		39.5		4.8		44.3		48.8		2.5		51.3		48.7		5.5		54.2
Adcirca	7.3		—		7.3		7.5		—		7.5		7.3		—		7.3		6.8		—		6.8
Other	2.3		0.2		2.5		3.2		0.3		3.5		1.7		0.2		1.9		2.6		1.3		3.9
Total revenues	$	469.7	$	37.2	$	506.9	$	562.0	$	34.5	$	596.5	$	584.6	$	24.8	$	609.4	$	585.9	$	28.8	$	614.7


	Three Months Ended
	March 31, 2022						June 30, 2022						September 30, 2022						December 31, 2022
	U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total
Net product sales:
Tyvaso DPI(1)	$	—	$	—	$	—	$	3.0	$	—	$	3.0	$	63.1	$	—	$	63.1	$	92.2	$	—	$	92.2
Nebulized Tyvaso(1)	170.1		1.9		172.0		196.2		1.8		198.0		193.9		0.7		194.6		148.4		1.7		150.1
Total Tyvaso	170.1		1.9		172.0		199.2		1.8		201.0		257.0		0.7		257.7		240.6		1.7		242.3
Remodulin(2)	99.1		32.6		131.7		108.5		23.5		132.0		102.2		11.8		114.0		97.7		24.8		122.5
Orenitram	82.8		—		82.8		79.0		—		79.0		87.5		—		87.5		75.8		—		75.8
Unituxin	48.0		7.6		55.6		43.3		1.2		44.5		42.8		3.3		46.1		36.4		0.3		36.7
Adcirca	9.8		—		9.8		10.4		—		10.4		10.7		—		10.7		10.4		—		10.4
Other	—		10.0		10.0		—		—		—		—		—		—		2.8		1.0		3.8
Total revenues	$	409.8	$	52.1	$	461.9	$	440.4	$	26.5	$	466.9	$	500.2	$	15.8	$	516.0	$	463.7	$	27.8	$	491.5


	Three Months Ended
	March 31, 2021						June 30, 2021						September 30, 2021						December 31, 2021
	U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total		U.S.		ROW		Total
Net product sales:
Tyvaso DPI(1)	$	—	$	—	$	—	$	—	$	—	$	—	$	—	$	—	$	—	$	—	$	—	$	—
Nebulized Tyvaso(1)	122.4		0.6		123.0		152.6		1.2		153.8		160.7		3.5		164.2		165.0		1.5		166.5
Total Tyvaso	122.4		0.6		123.0		152.6		1.2		153.8		160.7		3.5		164.2		165.0		1.5		166.5
Remodulin(2)	107.1		23.1		130.2		111.0		28.8		139.8		106.8		18.6		125.4		98.5		19.8		118.3
Orenitram	72.4		—		72.4		76.2		—		76.2		85.2		—		85.2		72.3		—		72.3
Unituxin	42.8		1.1		43.9		48.3		4.8		53.1		44.8		10.5		55.3		42.2		7.8		50.0
Adcirca	9.6		—		9.6		23.6		—		23.6		14.6		—		14.6		8.1		—		8.1
Other	—		—		—		—		—		—		—		—		—		—		—		—
Total revenues	$	354.3	$	24.8	$	379.1	$	411.7	$	34.8	$	446.5	$	412.1	$	32.6	$	444.7	$	386.1	$	29.1	$	415.2

(1) Net product sales include both the drug product and the respective inhalation device.

(2) Net product sales include sales of infusion devices including the Remunity Pump.


						8

Exhibit 99.2

For Immediate Release

United Therapeutics Commences Litigation to Ensure Fairness in the Drug Review Process

SILVER SPRING, Md., and RESEARCH TRIANGLE PARK, N.C., February 21, 2024 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.

This litigation addresses the FDA’s handling of Liquidia’s unlawful amendment to a pending new drug application (NDA) seeking to add a second indication, pulmonary hypertension associated with interstitial lung disease (PH-ILD), to the label of its proposed inhaled dry powder treprostinil product. United Therapeutics alleges in the litigation that the FDA’s rules, precedents, and procedures require that Liquidia seek approval for this second indication by filing a new NDA rather than filing an amendment to a pending NDA. United Therapeutics believes this distinction is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with the FDA’s prior practices with which industry has complied for decades.

Before 2021, every clinical trial of drugs approved for the treatment of pulmonary hypertension that were studied for the treatment of PH-ILD failed. Some approved PH therapies worsened patients’ pulmonary hypertension, and PH-ILD remained a disease for which there were no approved therapies.

Notwithstanding this clear record of failure by others in PH-ILD, United Therapeutics took the bold step at considerable expense to conduct an innovative pivotal trial of Tyvaso® (treprostinil) Inhalation Solution for the treatment of PH-ILD. This trial, called INCREASE, was the largest and most comprehensive completed study of patients with PH-ILD, and its successful results led the FDA to approve Tyvaso as the first ever treatment for PH-ILD in March 2021. The results of the INCREASE study were published in The New England Journal of Medicine in January 2021.

Under the Hatch-Waxman Act, when a company like Liquidia seeks approval of an application that relies on another drug’s prior approval and may infringe patents listed for that drug, a timely filed action for patent infringement prevents the FDA from approving an NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. By filing an amendment to its existing NDA rather than a new NDA, Liquidia avoided a 30-month stay of approval for PH-ILD despite Liquidia’s decision to rely on United Therapeutics’ prior approval for Tyvaso. By filing this litigation, United Therapeutics seeks to protect the equity afforded true pharmaceutical and biotech innovators through the correct and consistent interpretation of the FDA’s rules, precedents, and procedures. If United Therapeutics is successful in its litigation with FDA, a stay of up to 30 months could prevent final approval for Liquidia’s PH-ILD indication to allow separate patent litigation to be resolved.

“The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed,” said Dean Bunce, Executive Vice President, Global Regulatory Affairs at United Therapeutics. “We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators: Liquidia can rely on United Therapeutics’ innovation to speed its path to market, but the cost of that shortcut is that Liquidia must address the infringement claim against it before rushing to market.”

United Therapeutics previously sued Liquidia alleging infringement of U.S. Patent No. 11,826,327 (the ’327 patent) based on Liquidia’s efforts to obtain approval for the PH-ILD indication. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. The patent infringement case is currently pending in U.S. District Court for the District of Delaware.

About PH-ILD

Interstitial lung disease (ILD) is a group of lung diseases that are characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue.

Group 3 Pulmonary hypertension (PH) frequently complicates the course of patients with interstitial lung disease and is associated with worse functional status measured by exercise capacity, greater supplemental oxygen needs, decreased quality of life, and worse outcomes. PH is estimated to affect at least 15% of patients with early-stage ILD (approximately 30,000 PH-ILD patients in the United States) and may affect up to 86% of patients with more severe ILD.

About TYVASO® (treprostinil) Inhalation Solution

INDICATION

TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:

•Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

•Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

•TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.

•TYVASO inhibits platelet aggregation and increases the risk of bleeding.

•Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

•The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.

•Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.

•Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.

•Safety and effectiveness in pediatric patients have not been established.

•Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

•Pulmonary Arterial Hypertension (WHO Group 1)

In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.

•Pulmonary Hypertension Associated with ILD (WHO Group 3)

In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.

Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1 877 UNITHER (1-877-864-8437).

United Therapeutics: Enabling Inspiration

You can learn more about what it means to be a PBC here: unither.com/pbc.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our newly-filed litigation against the FDA, our ongoing litigation with Liquidia, and the potential to obtain a 30-month stay preventing the FDA from approving Liquidia’s inhaled treprostinil product for PH-ILD; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of February 21, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.

TYVASO is a registered trademark of United Therapeutics Corporation.

For Further Information Contact:

Dewey Steadman

Phone: (202) 919-4097

https://ir.unither.com/contact-ir/

Cover Page Document	Feb. 21, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Feb. 21, 2024
Entity Registrant Name	United Therapeutics Corporation
Entity Incorporation, State or Country Code	DE
Entity File Number	000-26301
Entity Tax Identification Number	52-1984749
Entity Address, Address Line One	1000 Spring Street
Entity Address, City or Town	Silver Spring,
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20910
City Area Code	301
Local Phone Number	608-9292
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	UTHR
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001082554
Amendment Flag	false