United Therapeutics Corporation (Nasdaq: UTHR), a public
benefit corporation, today announced its financial results for the
quarter and year ended December 31, 2024. Full year 2024 revenues
rose to a record $2.88 billion, reflecting 24% growth over
2023.
“I want to congratulate every Unitherian for their relentless
dedication, which has allowed us to deliver a third consecutive
year of record revenue,” said Martine Rothblatt, Ph.D.,
Chairperson and Chief Executive Officer of United Therapeutics. “On
top of that, our three-year cascade of clinical and regulatory
events is under way: both TETON studies in idiopathic pulmonary
fibrosis are enrolled, facilitating data starting the second half
of this year; ralinepag, our potentially best-in-class once-daily
oral prostacyclin agonist, will generate data next year; and this
month we announced FDA clearance to start the first potentially
registration-enabling xenotransplantation study with our
UKidney.”
Michael Benkowitz, President and Chief Operating Officer
of United Therapeutics, added, “Our commercial foundation continues
to operate from a place of strength, propelled by robust fourth
quarter performance across our product portfolio, which capped a
record-setting year. We look forward to continuing this momentum in
2025 as our sales and marketing teams continue their efforts to
ensure that prescribers are educated on the benefits of our broad
array of treprostinil products, which are widely regarded as a
cornerstone for treating pulmonary hypertension.”
Fourth Quarter and Full Year 2024 Financial Results
Key financial highlights include (in millions, except per share
data):
Three Months Ended
December 31,
Year Ended December
31,
2024
2023
2024
2023
Total revenues
$
735.9
$
614.7
$
2,877.4
$
2,327.5
Net income
$
301.3
$
217.1
$
1,195.1
$
984.8
Net income, per basic share
$
6.74
$
4.62
$
26.44
$
21.04
Net income, per diluted share
$
6.19
$
4.36
$
24.64
$
19.81
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
2024
2023
2024
2023
Net product sales:
Tyvaso DPI®(1)
$
273.2
$
213.7
$
59.5
28
%
$
1,033.6
$
731.1
$
302.5
41
%
Nebulized Tyvaso®(1)
142.7
136.9
5.8
4
%
586.8
502.6
84.2
17
%
Total Tyvaso
415.9
350.6
65.3
19
%
1,620.4
1,233.7
386.7
31
%
Remodulin®(2)
134.5
115.1
19.4
17
%
538.1
494.8
43.3
9
%
Orenitram®
107.8
84.1
23.7
28
%
434.3
359.4
74.9
21
%
Unituxin®
67.5
54.2
13.3
25
%
238.7
198.9
39.8
20
%
Adcirca®
4.7
6.8
(2.1
)
(31
)%
23.8
28.9
(5.1
)
(18
)%
Other
5.5
3.9
1.6
41
%
22.1
11.8
10.3
87
%
Total revenues
$
735.9
$
614.7
$
121.2
20
%
$
2,877.4
$
2,327.5
$
549.9
24
%
(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 2024 Compared to Fourth Quarter 2023.
Total Tyvaso revenues grew by 19 percent to $415.9 million in the
fourth quarter of 2024, compared to $350.6 million in the fourth
quarter of 2023. This growth was primarily driven by growth in
Tyvaso DPI revenues, which resulted from an increase in quantities
sold of $62.7 million and, to a lesser extent, a price increase,
partially offset by higher gross-to-net deductions. The increase in
Tyvaso DPI quantities sold was due to continued growth in the
number of patients following the product’s launch, including growth
in utilization by patients with pulmonary hypertension associated
with interstitial lung disease (PH-ILD) and, to a lesser
extent, increased commercial utilization following implementation
of the Part D redesign under the Inflation Reduction Act
(IRA). The growth in Remodulin revenues resulted from an
increase in U.S. Remodulin revenues and, to a lesser extent, an
increase in international Remodulin revenues, driven, in both
cases, by an increase in quantities sold. The increase in Orenitram
revenues resulted from an increase in quantities sold and, to a
lesser extent, a price increase. The increase in Orenitram
quantities sold was driven, at least in part, by increased
commercial utilization following the implementation of the Part D
redesign under the IRA. The increase in Unituxin revenues resulted
from an increase in quantities sold and a price increase.
Full Year 2024 Compared to Full Year 2023. Total Tyvaso
revenues grew by 31 percent to $1,620.4 million in 2024, compared
to $1,233.7 million in 2023. The growth in Tyvaso DPI revenues
resulted from an increase in quantities sold of $269.2 million and,
to a lesser extent, price increases, partially offset by higher
gross-to-net revenue deductions. The increase in Tyvaso DPI
quantities sold was primarily due to continued growth in the number
of patients following the product’s launch (including by PH-ILD
patients) and, to a lesser extent, increased commercial utilization
following implementation of the Part D redesign under the IRA. The
growth in nebulized Tyvaso revenues resulted primarily from an
increase in quantities sold of $51.9 million and, to a lesser
extent, a price increase. Growth in nebulized Tyvaso was also
driven by continued growth in use by PH-ILD patients. The growth in
Remodulin revenues resulted from an increase in U.S. Remodulin
revenues, driven by an increase in quantities sold. The growth in
Orenitram revenues resulted from an increase in quantities sold
and, to a lesser extent, a price increase. The increase in
Orenitram quantities sold was driven, at least in part, by
increased commercial utilization following the implementation of
the Part D redesign under the IRA. The growth in Unituxin revenues
resulted from a price increase and an increase in quantities
sold.
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,
2024
2023
2024
2023
U.S.
ROW
Total
U.S.
ROW
Total
U.S.
ROW
Total
U.S.
ROW
Total
Net product sales:
Tyvaso DPI(1)
$
272.8
$
0.4
$
273.2
$
213.7
$
—
$
213.7
$
1,033.2
$
0.4
$
1,033.6
$
731.1
$
—
$
731.1
Nebulized Tyvaso(1)
136.4
6.3
142.7
123.7
13.2
136.9
545.5
41.3
586.8
477.1
25.5
502.6
Total Tyvaso
409.2
6.7
415.9
337.4
13.2
350.6
1,578.7
41.7
1,620.4
1,208.2
25.5
1,233.7
Remodulin(2)
118.0
16.5
134.5
106.3
8.8
115.1
464.2
73.9
538.1
414.6
80.2
494.8
Orenitram
107.8
—
107.8
84.1
—
84.1
434.3
—
434.3
359.4
—
359.4
Unituxin
61.8
5.7
67.5
48.7
5.5
54.2
219.6
19.1
238.7
181.3
17.6
198.9
Adcirca
4.7
—
4.7
6.8
—
6.8
23.8
—
23.8
28.9
—
28.9
Other
4.2
1.3
5.5
2.6
1.3
3.9
19.1
3.0
22.1
9.8
2.0
11.8
Total revenues
$
705.7
$
30.2
$
735.9
$
585.9
$
28.8
$
614.7
$
2,739.7
$
137.7
$
2,877.4
$
2,202.2
$
125.3
$
2,327.5
(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
2024
2023
2024
2023
Category:
Cost of sales
$
74.8
$
70.1
$
4.7
7
%
$
304.3
$
255.1
$
49.2
19
%
Share-based compensation expense(1)
1.1
0.9
0.2
22
%
5.4
2.4
3.0
125
%
Total cost of sales
$
75.9
$
71.0
$
4.9
7
%
$
309.7
$
257.5
$
52.2
20
%
(1)
See Share-based compensation
below.
Cost of sales, excluding share-based compensation. The increase
in cost of sales for the year ended December 31, 2024, as compared
to the same period in 2023, was primarily due to an increase in
Tyvaso DPI royalty expense and product costs driven by growth in
Tyvaso DPI revenues.
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
2024
2023
2024
2023
Category:
External research and development(1)
$
63.7
$
50.4
$
13.3
26
%
$
217.5
$
192.0
$
25.5
13
%
Internal research and development(2)
50.3
43.2
7.1
16
%
183.6
146.6
37.0
25
%
Share-based compensation expense(3)
6.7
5.7
1.0
18
%
29.1
15.6
13.5
87
%
Other(4)
13.1
52.1
(39.0
)
(75
)%
50.8
53.8
(3.0
)
(6
)%
Total research and development
expense
$
133.8
$
151.4
$
(17.6
)
(12
)%
$
481.0
$
408.0
$
73.0
18
%
(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)
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 in-process research and development
(IPR&D) assets. During the year ended December 31, 2024,
we recorded $40.2 million and $8.0 million in expense related to
upfront non-refundable licensing payments for drug delivery device
technologies and ex vivo lung perfusion technology, respectively.
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).
Research and development, excluding share-based compensation.
The decrease in research and development expense for the quarter
ended December 31, 2024, as compared to the same period in 2023,
was primarily due to IPR&D expense we recorded in connection
with the acquisition of IVIVA during the quarter ended December 31,
2023; partially offset by increased expenditures related to
manufactured organ and organ alternative projects and upfront
non-refundable licensing payments related to ex vivo lung perfusion
technology.
The increase in research and development expense for the year
ended December 31, 2024, as compared to the same period in 2023,
was due to: (1) increased expenditures related to manufactured
organ and organ alternative projects; (2) non-refundable licensing
payments for drug delivery device technologies and ex vivo lung
perfusion technology; and (3) increased expenditures related to the
TETON studies of nebulized Tyvaso in patients with idiopathic
pulmonary fibrosis and progressive pulmonary fibrosis. These
increases were partially offset by the impact of an IPR&D
expense recorded during the year ended December 31, 2023 in
connection with the acquisition of IVIVA, which expense did not
recur in 2024.
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
2024
2023
2024
2023
Category:
General and administrative(1)
$
116.3
$
98.1
$
18.2
19
%
$
432.8
$
374.2
$
58.6
16
%
Litigation accrual
6.0
—
6.0
NM(3)
71.1
—
71.1
NM(3)
Sales and marketing
27.0
24.1
2.9
12
%
96.3
81.8
14.5
18
%
Share-based compensation expense(2)
19.2
10.0
9.2
92
%
109.5
21.1
88.4
419
%
Total selling, general, and
administrative expense
$
168.5
$
132.2
$
36.3
27
%
$
709.7
$
477.1
$
232.6
49
%
(1)
Excluding litigation accrual. See
Litigation accrual section below.
(2)
See Share-based compensation
below.
(3)
Calculation is not
meaningful.
General and administrative, excluding litigation accrual and
share-based compensation. The increase in general and
administrative expense for the quarter and year ended December 31,
2024, as compared to the same periods in 2023, was primarily due to
increases in: (1) personnel expense due to growth in headcount; (2)
legal expenses related to litigation matters; and (3) consulting
expenses.
Litigation accrual. As of December 31, 2024, we accrued a
liability of $71.1 million related to ongoing litigation with
Sandoz Inc., reflecting the final judgment and post-judgment
interest accrued through the end of 2024. We currently do not
expect that the amount of any loss in excess of this accrual would
be material to our financial results; however, the amount
ultimately payable, if any, could be higher or lower than this
amount depending on the amount of post judgment interest and the
outcome of appeals, as discussed in Note 14—Litigation, to our
consolidated financial statements included within our Annual Report
on Form 10-K for the year ended December 31, 2024. The litigation
accrual is included within selling, general, and administrative in
our consolidated statements of operations.
Sales and marketing, excluding share-based compensation. The
increase in sales and marketing expense for the year ended December
31, 2024, as compared to the same period in 2023, was primarily due
to increases in: (1) personnel expense due to growth in headcount;
(2) marketing expenses; and (3) 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
2024
2023
2024
2023
Category:
Stock options
$
8.0
$
2.9
$
5.1
176
%
$
29.8
$
15.4
$
14.4
94
%
Restricted stock units
17.8
14.1
3.7
26
%
79.7
52.4
27.3
52
%
Share tracking awards plan
(STAP)
0.6
(0.9
)
1.5
167
%
32.3
(30.7
)
63.0
205
%
Employee stock purchase plan
0.6
0.5
0.1
20
%
2.2
2.0
0.2
10
%
Total share-based compensation
expense
$
27.0
$
16.6
$
10.4
63
%
$
144.0
$
39.1
$
104.9
268
%
The increase in share-based compensation expense for the quarter
ended December 31, 2024, as compared to the same period in 2023,
was primarily due to: (1) an increase in stock option expense due
to a greater number of awards granted in 2024, as compared to the
same period in 2023; (2) an increase in restricted stock unit
expense due to a greater number of awards remaining outstanding in
2024, as compared to the same period in 2023; and (3) an increase
in STAP expense driven by a two percent decrease in our stock price
during the quarter ended December 31, 2024, as compared to a three
percent decrease in our stock price for the same period in 2023.
The increase in share-based compensation expense for the year ended
December 31, 2024, as compared to the same period in 2023, was
primarily due to: (1) an increase in STAP expense driven by a 60
percent increase in our stock price during 2024, as compared to a
21 percent decrease in our stock price during 2023; (2) an increase
in restricted stock unit expense due to a greater number of awards
granted and remaining outstanding in 2024, as compared to the same
period in 2023; and (3) an increase in stock option expense due to
a greater number of awards granted in 2024, as compared to the same
period in 2023.
Other (expense) income, net. The change in other
(expense) income, net for the year ended December 31, 2024, as
compared to the same period in 2023, was primarily due to net
unrealized gains on equity securities.
Income tax expense. Income tax expense was $343.9 million
for the year ended December 31, 2024, compared to $289.5 million
for the same period in 2023. For the years ended December 31, 2024
and 2023, our effective income tax rates (ETR) were
approximately 22 percent and 23 percent, respectively. Our ETR for
the year ended December 31, 2024 decreased, compared to our ETR for
the year ended December 31, 2023, primarily due to a decrease in
nondeductible acquisition costs and an increase in excess tax
benefits from share-based compensation, partially offset by an
increase in nondeductible compensation.
Share repurchase. In March 2024, we entered into an
accelerated share repurchase agreement (the ASR agreement)
with Citibank, N.A. (Citi). Under the ASR agreement, we made
an aggregate upfront payment of $1.0 billion to Citi and received
an aggregate initial delivery of 3,275,199 shares of our common
stock on March 27, 2024, which represented approximately 80 percent
of the total shares that would be repurchased under the ASR
agreement, measured based on the closing price of our common stock
on March 25, 2024.
The share repurchase under the ASR agreement was divided into
two tranches, resulting in upfront payments of $300 million and
$700 million, respectively. The final settlement of the $300
million tranche occurred in June 2024, and we received an
additional 181,772 shares of our common stock upon settlement. The
final settlement of the $700 million tranche occurred in September
2024, and we received an additional 90,403 shares of our common
stock upon settlement. In total, we repurchased 3,547,374 shares of
our common stock under the ASR agreement that we currently hold as
treasury stock in our consolidated balance sheets.
Webcast
We will host a webcast to discuss our fourth quarter and full
year 2024 financial results on Wednesday, February 26, 2025, at
9:00 a.m. Eastern Time. The webcast can be accessed live via our
website at https://ir.unither.com/events-and-presentations. 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 anticipated readouts of our TETON and ralinepag
clinical trials; our plans to commence a clinical trial of our
UKidney product, and that it may be registration-enabling; our
expectation that ralinepag may be a best-in-class once-daily
prostacyclin agonist; our expectation that our momentum will
continue into 2025; our expectations concerning our ultimate
liability resulting from our litigation with Sandoz Inc., including
our expectation that the amount of any loss in excess of our $71.1
million accrual will not be material to our financial results; 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 26, 2025, 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.
ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN
are registered trademarks of United Therapeutics Corporation and/or
its subsidiaries.
UKIDNEY is a trademark of United Therapeutics Corporation and/or
its subsidiaries.
ADCIRCA is a registered trademark of Eli Lilly and Company.
UNITED THERAPEUTICS
CORPORATION
CONSOLIDATED STATEMENTS OF
OPERATIONS
(In millions, except per share
data)
Three Months Ended
December 31,
Year Ended December
31,
2024
2023
2024
2023
(Unaudited)
Total revenues
$
735.9
$
614.7
$
2,877.4
$
2,327.5
Operating expenses:
Cost of sales
75.9
71.0
309.7
257.5
Research and development
133.8
151.4
481.0
408.0
Selling, general, and administrative
168.5
132.2
709.7
477.1
Total operating expenses
378.2
354.6
1,500.4
1,142.6
Operating income
357.7
260.1
1,377.0
1,184.9
Interest income
49.3
51.0
199.1
162.7
Interest expense
(7.9
)
(15.1
)
(42.9
)
(59.3
)
Other (expense) income, net
(2.6
)
(0.6
)
5.8
(14.0
)
Total other income, net
38.8
35.3
162.0
89.4
Income before income taxes
396.5
295.4
1,539.0
1,274.3
Income tax expense
(95.2
)
(78.3
)
(343.9
)
(289.5
)
Net income
$
301.3
$
217.1
$
1,195.1
$
984.8
Net income per common share:
Basic
$
6.74
$
4.62
$
26.44
$
21.04
Diluted
$
6.19
$
4.36
$
24.64
$
19.81
Weighted average number of common shares
outstanding:
Basic
44.7
47.0
45.2
46.8
Diluted
48.7
49.8
48.5
49.7
SELECTED CONSOLIDATED BALANCE
SHEET DATA
(In millions)
December 31,
2024
2023
Cash, cash equivalents, and marketable
investments
$
4,742.3
$
4,903.9
Total assets
7,364.0
7,167.0
Total liabilities
920.0
1,182.2
Total stockholders' equity
6,444.0
5,984.8
Category: Earnings
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version on businesswire.com: https://www.businesswire.com/news/home/20250226509986/en/
Dewey Steadman at (202) 919-4097 (media/investors) Harry Silvers
at (301) 578-1401 (investors) https://ir.unither.com/contact-ir
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