United Therapeutics Corporation (Nasdaq: UTHR), a public
benefit corporation, today announced its financial results for the
quarter ended June 30, 2024. Total revenues in the second quarter
of 2024 grew 20 percent year-over-year to $714.9 million, compared
to $596.5 million in the second quarter of 2023.
“This quarter we drove record revenue from our foundational
commercial business. Next year we expect data from our innovative
clinical pipeline. All this while we march forward with our
revolutionary organ manufacturing programs,” said Martine
Rothblatt, Ph.D., Chairperson and Chief Executive Officer of
United Therapeutics. “We believe there is no other biotech with our
combination of relentless focus, near-term commercial growth, and
clinical potential.”
Michael Benkowitz, President and Chief Operating Officer
of United Therapeutics, added, “Our fifth straight quarter of
record revenue was driven by continued traction for Tyvaso in
pulmonary hypertension associated with interstitial lung disease,
along with strong fundamentals for our other products in pulmonary
arterial hypertension and neuroblastoma.”
Second Quarter 2024 Financial Results
Key financial highlights include (dollars in millions, except
per share data):
Three Months Ended June
30,
Dollar Change
Percentage Change
2024
2023
Total revenues
$
714.9
$
596.5
$
118.4
20
%
Net income
$
278.1
$
259.2
$
18.9
7
%
Net income, per basic share
$
6.26
$
5.53
$
0.73
13
%
Net income, per diluted share
$
5.85
$
5.24
$
0.61
12
%
Revenues
The table below presents the components of total revenues
(dollars in millions):
Three Months Ended June
30,
Dollar Change
Percentage
Change
2024
2023
Net product sales:
Tyvaso DPI®(1)
$
258.3
$
193.6
$
64.7
33
%
Nebulized Tyvaso®(1)
139.9
125.3
14.6
12
%
Total Tyvaso
398.2
318.9
79.3
25
%
Remodulin®(2)
147.3
127.2
20.1
16
%
Orenitram®
107.1
95.1
12.0
13
%
Unituxin®
51.7
44.3
7.4
17
%
Adcirca®
5.7
7.5
(1.8
)
(24
)%
Other
4.9
3.5
1.4
40
%
Total revenues
$
714.9
$
596.5
$
118.4
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.
Total Tyvaso revenues grew by 25 percent to $398.2 million in
the second quarter of 2024, compared to $318.9 million in the
second quarter of 2023. 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 commercial
utilization by patients with pulmonary hypertension associated with
interstitial lung disease and, to a lesser extent, price
increases.
The growth in Tyvaso DPI revenues resulted primarily from an
increase in quantities sold and, to a lesser extent, price
increases. The increase in Tyvaso DPI quantities sold was due to
continued growth in the number of patients following the product’s
launch and, to a lesser extent, increased commercial utilization
following the implementation of the Part D redesign under the
Inflation Reduction Act (IRA).
The growth in Remodulin revenues resulted primarily from an
increase in U.S. Remodulin revenues, driven by an increase in
quantities sold and, to a lesser extent, lower Medicaid
rebates.
The growth in Orenitram revenues resulted primarily from an
increase in quantities sold and, to a lesser extent, a price
increase. The increase in 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 June
30,
2024
2023
U.S.
ROW
Total
U.S.
ROW
Total
Net product sales:
Tyvaso DPI(1)
$
258.3
$
—
$
258.3
$
193.6
$
—
$
193.6
Nebulized Tyvaso(1)
130.2
9.7
139.9
119.6
5.7
125.3
Total Tyvaso
388.5
9.7
398.2
313.2
5.7
318.9
Remodulin(2)
122.5
24.8
147.3
103.5
23.7
127.2
Orenitram
107.1
—
107.1
95.1
—
95.1
Unituxin
46.8
4.9
51.7
39.5
4.8
44.3
Adcirca
5.7
—
5.7
7.5
—
7.5
Other
4.6
0.3
4.9
3.2
0.3
3.5
Total revenues
$
675.2
$
39.7
$
714.9
$
562.0
$
34.5
$
596.5
(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 June
30,
Dollar Change
Percentage Change
2024
2023
Category:
Cost of sales
$
75.9
$
63.2
$
12.7
20
%
Share-based compensation expense(1)
1.9
0.9
1.0
111
%
Total cost of sales
$
77.8
$
64.1
$
13.7
21
%
(1)
See Share-based compensation
below.
Cost of sales, excluding share-based compensation. Cost of sales
for the three months ended June 30, 2024 increased as compared to
the same period in 2023, primarily due to an increase in Tyvaso DPI
royalty expense.
Research and development. The table below summarizes the
nature of research and development expense by major expense
category (dollars in millions):
Three Months Ended June
30,
Dollar Change
Percentage Change
2024
2023
Category:
External research and development(1)
$
49.4
$
49.3
$
0.1
—
%
Internal research and development(2)
44.5
34.7
9.8
28
%
Share-based compensation expense(3)
8.6
5.0
3.6
72
%
Impairments(4)
—
—
—
—
%
Other(5)
37.1
—
37.1
NM
(6)
Total research and development expense
$
139.6
$
89.0
$
50.6
57
%
(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 and of certain property, plant, and
equipment as a result of research and development activities. There
were no impairment charges during the three months ended June 30,
2024 and June 30, 2023.
(5)
Other primarily includes upfront
fees and milestone payments to third parties under license
agreements related to development-stage products and adjustments to
the fair value of our contingent consideration obligations.
(6)
Calculation is not
meaningful.
Research and development, excluding share-based compensation.
Research and development expense for the three months ended June
30, 2024 increased as compared to the same period in 2023,
primarily due to increased expenditures related to upfront
non-refundable licensing payments for drug delivery devices and
increased expenditures related to organ manufacturing projects.
Selling, general, and administrative. The table below
summarizes selling, general, and administrative expense by major
category (dollars in millions):
Three Months Ended June
30,
Dollar Change
Percentage Change
2024
2023
Category:
General and administrative
$
113.0
$
102.0
$
11.0
11
%
Sales and marketing
25.4
20.1
5.3
26
%
Share-based compensation expense(1)
39.2
7.9
31.3
396
%
Total selling, general, and administrative
expense
$
177.6
$
130.0
$
47.6
37
%
(1)
See Share-based compensation below.
General and administrative, excluding share-based compensation.
General and administrative expense for the three months ended June
30, 2024 increased as compared to the same period in 2023,
primarily due to an increase in legal expenses related to
litigation matters and an increase in personnel expense due to
growth in headcount.
Share-based compensation. The table below summarizes
share-based compensation expense by major category (dollars in
millions):
Three Months Ended
June 30,
Dollar Change
Percentage Change
2024
2023
Category:
Stock options
$
8.1
$
1.6
$
6.5
406
%
Restricted stock units
19.2
13.6
5.6
41
%
Share tracking awards plan
(STAP)
21.9
(1.9
)
23.8
NM
(1)
Employee stock purchase plan
0.5
0.5
—
—
%
Total share-based compensation expense
$
49.7
$
13.8
$
35.9
260
%
(1)
Calculation is not meaningful.
The increase in share-based compensation expense for the three
months ended June 30, 2024, as compared to the same period in 2023,
was primarily due to an increase in STAP expense driven by a 39
percent increase in our stock price for the three months ended June
30, 2024, as compared to a one percent decrease in our stock price
for the same period in 2023.
Income tax expense. Income tax expense for the three
months ended June 30, 2024 and 2023 was $77.2 million and $76.0
million, respectively. Our effective income tax rate (ETR)
for the three months ended June 30, 2024 and 2023 was 22 percent
and 23 percent, respectively. Our ETR for the three months ended
June 30, 2024 decreased compared to our ETR for the three months
ended June 30, 2023 primarily due to a lower amount of uncertain
tax positions recorded.
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, representing 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 purchase 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. At the final
settlement of the $700 million second tranche, which we expect to
occur in the third quarter of 2024, we may be entitled to receive
additional shares of common stock, or, under certain limited
circumstances, be required to make a cash payment to Citi or, if we
so elect, deliver shares of common stock to Citi.
The final number of shares that we will ultimately repurchase
pursuant to the ASR agreement will be based on the average of the
daily volume-weighted average price per share of our common stock
during the repurchase period, less a discount and subject to
adjustments pursuant to the terms and conditions of the ASR
agreement.
Webcast
We will host a webcast to discuss our second quarter 2024
financial results on Wednesday, July 31, 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. 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 near-term commercial growth; the
anticipated progress of our organ manufacturing programs; our
clinical potential, including anticipated clinical trial data next
year; our unique position in the biotech industry; 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 July 31, 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.
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.
UNITED THERAPEUTICS
CORPORATION
CONSOLIDATED STATEMENTS OF
OPERATIONS
(In millions, except per share
data)
Three Months Ended
June 30,
2024
2023
(Unaudited)
Total revenues
$
714.9
$
596.5
Operating expenses:
Cost of sales
77.8
64.1
Research and development
139.6
89.0
Selling, general, and administrative
177.6
130.0
Total operating expenses
395.0
283.1
Operating income
319.9
313.4
Interest income
46.2
37.2
Interest expense
(11.6
)
(14.8
)
Other income (expense), net
0.8
(0.6
)
Total other income, net
35.4
21.8
Income before income taxes
355.3
335.2
Income tax expense
(77.2
)
(76.0
)
Net income
$
278.1
$
259.2
Net income per common share:
Basic
$
6.26
$
5.53
Diluted
$
5.85
$
5.24
Weighted average number of common shares
outstanding:
Basic
44.4
46.9
Diluted
47.5
49.5
SELECTED CONSOLIDATED BALANCE
SHEET DATA
(Unaudited, in
millions)
June 30, 2024
Cash, cash equivalents, and marketable
investments
$
4,301.9
Total assets
6,723.2
Total liabilities
1,026.0
Total stockholders’ equity
5,697.2
Category: Earnings
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240731653485/en/
Dewey Steadman at (202) 919-4097
https://ir.unither.com/contact-ir
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