United Therapeutics Corporation (Nasdaq: UTHR), a public benefit
corporation, today announced its financial results for the quarter
ended March 31, 2023. Total revenues in the first quarter of 2023
grew 10% year-over-year to $506.9 million, compared to $461.9
million in the first quarter of 2022.
“The hard work and determination of our over 1,000 Unitherians
during the first quarter of this year allowed us to reach over $500
million in revenue for the second quarter ever,” said Martine
Rothblatt, Ph.D., Chairperson and Chief Executive Officer. “And
to sustain our mission to help patients in need, our clinical team
continues to progress our four registration studies in progress:
the two TETON studies of Tyvaso in idiopathic pulmonary fibrosis,
the ADVANCE OUTCOMES study of ralinepag in pulmonary arterial
hypertension, and the clinical study of our CLES ex vivo lung
perfusion technology.”
“We are extremely pleased with the underlying strength of our
Tyvaso franchise, highlighted by record referrals and starts during
the quarter and net patient additions in line with prior quarters,”
said Michael Benkowitz, President and Chief Operating
Officer. “Our other core products also performed well, led by
Orenitram which achieved record revenues in the first quarter.”
First Quarter 2023 Financial
Results
Key financial highlights include (dollars
in millions, except per share data):
Three Months Ended
March 31,
Dollar Change
Percentage Change
2023
2022
Total revenues
$
506.9
$
461.9
$
45.0
10
%
Net income
$
240.9
$
239.9
$
1.0
—
%
Net income, per basic share
$
5.20
$
5.31
$
(0.11)
(2
) %
Net income, per diluted share
$
4.86
$
5.03
$
(0.17)
(3
) %
Revenues
The table below presents the components of
total revenues (dollars in millions):
Three Months Ended
March 31,
Dollar Change
Percentage
Change
2023
2022
Net product sales:
Tyvaso®(1)
$
238.4
$
172.0
$
66.4
39
%
Remodulin®(2)
121.4
131.7
(10.3)
(8
) %
Orenitram®
88.2
82.8
5.4
7
%
Unituxin®
49.1
55.6
(6.5)
(12
) %
Adcirca®
7.3
9.8
(2.5)
(26
) %
Other
2.5
10.0
(7.5)
(75
) %
Total revenues
$
506.9
$
461.9
$
45.0
10
%
(1)
Net product sales include both the drug
product and the respective inhalation devices for both nebulized
Tyvaso Inhalation Solution and the dry powder version known as
Tyvaso DPI®.
(2)
Net product sales include sales of
infusion devices, such as the Remunity® Pump.
Net product sales from our treprostinil-based products (Tyvaso,
Remodulin, and Orenitram) grew by $61.5 million, or 16%, for the
first quarter of 2023, as compared to the first quarter of 2022.
The growth in Tyvaso revenues resulted primarily from an increase
in quantities sold. The increase in quantities sold was driven by
our launch of sales of Tyvaso DPI in June 2022 and continued growth
in the number of patients following the Tyvaso label expansion in
March 2021 to include the treatment of pulmonary hypertension
associated with interstitial lung disease.
Expenses
Cost of sales. The table below
summarizes cost of sales by major category (dollars in
millions):
Three Months Ended
March 31,
Dollar Change
Percentage Change
2023
2022
Category:
Cost of sales
$
52.7
$
26.6
$
26.1
98
%
Share-based compensation benefit(1)
(0.4
)
(0.7
)
0.3
43
%
Total cost of sales
$
52.3
$
25.9
$
26.4
102
%
(1)
Refer to Share-based compensation
below.
Cost of sales, excluding share-based compensation. Cost of sales
for the three months ended March 31, 2023 increased as compared to
the same period in 2022, primarily due to an increase in Tyvaso DPI
royalty expense and product costs, following the commercial launch
of the product in June 2022.
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
March 31,
Dollar Change
Percentage Change
2023
2022
Category:
External research and development(1)
$
45.1
$
40.6
$
4.5
11
%
Internal research and development(2)
34.4
32.0
2.4
8
%
Share-based compensation expense
(benefit)(3)
1.3
(3.6
)
4.9
136
%
Impairments(4)
—
—
—
—
%
Other(5)
2.1
—
2.1
NM(6)
Total research and development
expense
$
82.9
$
69.0
$
13.9
20
%
(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)
Refer to 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 March 31, 2023 and
March 31, 2022.
(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 expense, excluding share-based
compensation. Research and development expense for the three months
ended March 31, 2023 increased as compared to the same period in
2022, primarily due to increased expenditures related to the TETON
clinical studies of Tyvaso in patients with idiopathic pulmonary
fibrosis.
Selling, general, and administrative expense. The table
below summarizes selling, general, and administrative expense by
major category (dollars in millions):
Three Months Ended
March 31,
Dollar Change
Percentage Change
2023
2022
Category:
General and administrative
$
83.7
$
81.3
$
2.4
3
%
Sales and marketing
16.9
14.5
2.4
17
%
Share-based compensation benefit(1)
(13.3
)
(16.8
)
3.5
21
%
Total selling, general, and
administrative expense
$
87.3
$
79.0
$
8.3
11
%
(1)
Refer to Share-based compensation
below.
Share-based compensation. The table
below summarizes share-based compensation benefit by major
category
(dollars in millions):
Three Months Ended
March 31,
Dollar Change
Percentage Change
2023
2022
Category:
Stock options
$
4.9
$
5.5
$
(0.6
)
(11
) %
Restricted stock units
12.2
6.3
5.9
94
%
Share tracking awards plan
(STAP)
(30.0
)
(33.4
)
3.4
10
%
Employee stock purchase plan
0.5
0.5
—
—
%
Total share-based compensation
benefit
$
(12.4
)
$
(21.1
)
$
8.7
41
%
The decrease in share-based compensation benefit for the three
months ended March 31, 2023, as compared to the same period in
2022, was primarily due to: (1) an increase in restricted stock
unit expense driven by an increase in the number of awards granted
and remaining outstanding for the three months ended March 31,
2023, as compared to the same period in 2022; and (2) a decrease in
STAP benefit driven by a 19 percent decrease in our stock price and
fewer awards remaining outstanding for the three months ended March
31, 2023, as compared to the same period in 2022.
Other (expense) income, net. The change in other
(expense) income, net for the three months ended March 31, 2023, as
compared to the same period in 2022, was primarily due to net
unrealized gains and losses on equity securities.
Income tax expense. Income tax expense for the three
months ended March 31, 2023 and 2022 was $51.0 million and $68.8
million, respectively. Our effective income tax rate (ETR)
for the three months ended March 31, 2023 and 2022 was 17 percent
and 22 percent, respectively. Our ETR for the three months ended
March 31, 2023 decreased compared to our ETR for the three months
ended March 31, 2022 primarily due to increased excess tax benefits
from share-based compensation.
Webcast
We will host a webcast to discuss our first quarter 2023
financial results on Wednesday, May 3, 2023, 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 efforts to sustain our mission to help patients in
need, our clinical trials and other research and development plans,
including the TETON studies of Tyvaso, the ADVANCE OUTCOMES study
of ralinepag, our clinical study of the CLES ex vivo lung perfusion
technology, 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, providing superior financial performance for
shareholders, and providing our communities with earth-sensitive
energy utilization. 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 May 3, 2023, 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
March 31,
2023
2022
(Unaudited)
Total revenues
$
506.9
$
461.9
Operating expenses:
Cost of sales
52.3
25.9
Research and development
82.9
69.0
Selling, general, and administrative
87.3
79.0
Total operating expenses
222.5
173.9
Operating income
284.4
288.0
Interest income
29.2
4.3
Interest expense
(13.8
)
(4.7
)
Other (expense) income, net
(7.9
)
22.8
Impairment of investment in privately-held
company
—
(1.7
)
Total other income, net
7.5
20.7
Income before income taxes
291.9
308.7
Income tax expense
(51.0
)
(68.8
)
Net income
$
240.9
$
239.9
Net income per common share:
Basic
$
5.20
$
5.31
Diluted
$
4.86
$
5.03
Weighted average number of common shares
outstanding:
Basic
46.3
45.2
Diluted
49.6
47.7
SELECTED CONSOLIDATED BALANCE
SHEET DATA
(Unaudited, in
millions)
March 31, 2023
Cash, cash equivalents, and marketable
investments
$
4,629.0
Total assets
6,346.0
Total liabilities
1,222.8
Total stockholders’ equity
5,123.2
Category: Earnings
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230503005111/en/
For Further Information Contact: Dewey Steadman at (202)
919-4097 Email: ir@unither.com
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