United Therapeutics Corporation Reports Third Quarter 2024 Financial Results
"I’m proud of the close to 1,300 Unitherians who have contributed to yet another record revenue quarter and reaching a
Third Quarter 2024 Financial Results
Key financial highlights include (dollars in millions, except per share data):
|
Three Months Ended
|
|
Dollar
|
|
Percentage
|
|||||
|
2024 |
|
2023 |
|
|
|||||
|
|
|
|
|
|
|
|
|||
Total revenues |
$ |
748.9 |
|
$ |
609.4 |
|
$ |
139.5 |
|
23 % |
Net income |
$ |
309.1 |
|
$ |
267.6 |
|
$ |
41.5 |
|
16 % |
Net income, per basic share |
$ |
6.93 |
|
$ |
5.71 |
|
$ |
1.22 |
|
21 % |
Net income, per diluted share |
$ |
6.39 |
|
$ |
5.38 |
|
$ |
1.01 |
|
19 % |
Revenues
The table below presents the components of total revenues (dollars in millions):
|
Three Months Ended
|
|
Dollar
|
|
Percentage
|
||||||
|
2024 |
|
2023 |
|
|
||||||
Net product sales: |
|
|
|
|
|
|
|
||||
Tyvaso DPI®(1) |
$ |
274.6 |
|
$ |
205.1 |
|
$ |
69.5 |
|
|
34 % |
Nebulized Tyvaso®(1) |
|
159.2 |
|
|
120.7 |
|
|
38.5 |
|
|
32 % |
Total Tyvaso |
|
433.8 |
|
|
325.8 |
|
|
108.0 |
|
|
33 % |
Remodulin®(2) |
|
128.3 |
|
|
131.1 |
|
|
(2.8 |
) |
|
(2) % |
Orenitram® |
|
113.2 |
|
|
92.0 |
|
|
21.2 |
|
|
23 % |
Unituxin® |
|
61.1 |
|
|
51.3 |
|
|
9.8 |
|
|
19 % |
Adcirca® |
|
7.0 |
|
|
7.3 |
|
|
(0.3 |
) |
|
(4) % |
Other |
|
5.5 |
|
|
1.9 |
|
|
3.6 |
|
|
189 % |
Total revenues |
$ |
748.9 |
|
$ |
609.4 |
|
$ |
139.5 |
|
|
23 % |
|
(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 33 percent to
The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase. 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 nebulized Tyvaso revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase.
The decrease in Remodulin revenues resulted from a decrease in international Remodulin revenues, partially offset by an increase in
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, and an increase in the average dose.
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
|
Three Months Ended |
||||||||||||
|
2024 |
|
2023 |
||||||||||
|
|
ROW |
Total |
|
|
ROW |
Total |
||||||
Net product sales: |
|
|
|
|
|
|
|
||||||
Tyvaso DPI(1) |
$ |
274.6 |
$ |
— |
$ |
274.6 |
|
$ |
205.1 |
$ |
— |
$ |
205.1 |
Nebulized Tyvaso(1) |
|
145.2 |
|
14.0 |
|
159.2 |
|
|
118.1 |
|
2.6 |
|
120.7 |
Total Tyvaso |
|
419.8 |
|
14.0 |
|
433.8 |
|
|
323.2 |
|
2.6 |
|
325.8 |
Remodulin(2) |
|
115.4 |
|
12.9 |
|
128.3 |
|
|
111.6 |
|
19.5 |
|
131.1 |
Orenitram |
|
113.2 |
|
— |
|
113.2 |
|
|
92.0 |
|
— |
|
92.0 |
Unituxin |
|
57.6 |
|
3.5 |
|
61.1 |
|
|
48.8 |
|
2.5 |
|
51.3 |
Adcirca |
|
7.0 |
|
— |
|
7.0 |
|
|
7.3 |
|
— |
|
7.3 |
Other |
|
4.3 |
|
1.2 |
|
5.5 |
|
|
1.7 |
|
0.2 |
|
1.9 |
Total revenues |
$ |
717.3 |
$ |
31.6 |
$ |
748.9 |
|
$ |
584.6 |
$ |
24.8 |
$ |
609.4 |
(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
|
|
Dollar
|
|
Percentage
|
|||||
|
2024 |
|
2023 |
|
|
|||||
Category: |
|
|
|
|
|
|
|
|||
Cost of sales |
$ |
81.8 |
|
$ |
69.1 |
|
$ |
12.7 |
|
18 % |
Share-based compensation expense(1) |
|
1.3 |
|
|
1.0 |
|
|
0.3 |
|
30 % |
Total cost of sales |
$ |
83.1 |
|
$ |
70.1 |
|
$ |
13.0 |
|
19 % |
(1) |
See Share-based compensation below. |
Cost of sales, excluding share-based compensation. Cost of sales for the three months ended
Research and development. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):
|
Three Months Ended
|
|
Dollar
|
|
Percentage
|
||||||
|
2024 |
|
2023 |
|
|
||||||
Category: |
|
|
|
|
|
|
|
||||
External research and development(1) |
$ |
51.7 |
|
$ |
47.2 |
|
|
$ |
4.5 |
|
10 % |
Internal research and development(2) |
|
43.9 |
|
|
34.3 |
|
|
|
9.6 |
|
28 % |
Share-based compensation expense(3) |
|
7.4 |
|
|
3.6 |
|
|
|
3.8 |
|
106 % |
Other(4) |
|
0.5 |
|
|
(0.4 |
) |
|
|
0.9 |
|
225 % |
Total research and development expense |
$ |
103.5 |
|
$ |
84.7 |
|
|
$ |
18.8 |
|
22 % |
(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 and adjustments to the fair value of our contingent consideration obligations. |
Research and development, excluding share-based compensation. Research and development expense for the three months ended
Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar
|
|
Percentage
|
|||||
|
2024 |
|
2023 |
|
|
|||||
Category: |
|
|
|
|
|
|
|
|||
General and administrative(1) |
$ |
100.4 |
|
$ |
90.4 |
|
$ |
10.0 |
|
11 % |
Litigation accrual |
|
65.1 |
|
|
— |
|
|
65.1 |
|
NM(2) |
Sales and marketing |
|
20.7 |
|
|
20.7 |
|
|
— |
|
— % |
Share-based compensation expense(3) |
|
33.0 |
|
|
16.5 |
|
|
16.5 |
|
100 % |
Total selling, general, and administrative expense |
$ |
219.2 |
|
$ |
127.6 |
|
$ |
91.6 |
|
72 % |
(1) |
Excluding litigation accrual. See Litigation accrual section below. |
(2) |
Calculation is not meaningful. |
(3) |
See Share-based compensation below. |
General and administrative, excluding litigation accrual and share-based compensation. General and administrative expense for the three months ended
Litigation accrual.
In the third quarter of 2024, we accrued a liability of
Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar
|
|
Percentage
|
|||||
|
2024 |
|
2023 |
|
|
|||||
Category: |
|
|
|
|
|
|
|
|||
Stock options |
$ |
8.0 |
|
$ |
6.0 |
|
$ |
2.0 |
|
33 % |
Restricted stock units |
|
27.2 |
|
|
12.5 |
|
|
14.7 |
|
118 % |
Share tracking awards plan |
|
5.9 |
|
|
2.1 |
|
|
3.8 |
|
181 % |
Employee stock purchase plan |
|
0.6 |
|
|
0.5 |
|
|
0.1 |
|
20 % |
Total share-based compensation expense |
$ |
41.7 |
|
$ |
21.1 |
|
$ |
20.6 |
|
98 % |
The increase in share-based compensation expense for the three months ended
Other income (expense), net. The change in other income (expense), net for the three months ended
Income tax expense.
Income tax expense for the three months ended
Share repurchase. In
The share repurchase under the ASR agreement was divided into two tranches, resulting in upfront payments of
Webcast
We will host a webcast to discuss our third quarter 2024 financial results on
At
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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 clinical data reads and regulatory events, and their potential to propel our growth, including expectations concerning the timing and success of the TETON, ADVANCE OUTCOMES, and miroliverELAP studies, and the potential launch of our UKidney human clinical program and the timing of our anticipated investigational new drug application filing for UKidney; the increasing demand for our products serving pulmonary hypertension and high-risk neuroblastoma patients; the expectation that Tyvaso DPI will be a near-term growth driver; 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
ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of
MIROLIVERELAP and UKIDNEY are trademarks of
ADCIRCA is a registered trademark of Eli Lilly and Company.
|
|||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||
(In millions, except per share data) |
|||||||
|
Three Months Ended
|
||||||
|
2024 |
|
2023 |
||||
|
(Unaudited) |
||||||
Total revenues |
$ |
748.9 |
|
|
$ |
609.4 |
|
Operating expenses: |
|
|
|
||||
Cost of sales |
|
83.1 |
|
|
|
70.1 |
|
Research and development |
|
103.5 |
|
|
|
84.7 |
|
Selling, general, and administrative |
|
219.2 |
|
|
|
127.6 |
|
Total operating expenses |
|
405.8 |
|
|
|
282.4 |
|
Operating income |
|
343.1 |
|
|
|
327.0 |
|
Interest income |
|
49.8 |
|
|
|
45.3 |
|
Interest expense |
|
(10.1 |
) |
|
|
(15.6 |
) |
Other income (expense), net |
|
5.8 |
|
|
|
(4.9 |
) |
Total other income, net |
|
45.5 |
|
|
|
24.8 |
|
Income before income taxes |
|
388.6 |
|
|
|
351.8 |
|
Income tax expense |
|
(79.5 |
) |
|
|
(84.2 |
) |
Net income |
$ |
309.1 |
|
|
$ |
267.6 |
|
Net income per common share: |
|
|
|
||||
Basic |
$ |
6.93 |
|
|
$ |
5.71 |
|
Diluted |
$ |
6.39 |
|
|
$ |
5.38 |
|
Weighted average number of common shares outstanding: |
|
|
|
||||
Basic |
|
44.6 |
|
|
|
46.9 |
|
Diluted |
|
48.4 |
|
|
|
49.7 |
|
SELECTED CONSOLIDATED BALANCE SHEET DATA |
||
(Unaudited, in millions) |
||
|
|
|
Cash, cash equivalents, and marketable investments |
$ |
4,605.9 |
Total assets |
|
7,123.1 |
Total liabilities |
|
1,022.2 |
Total stockholders’ equity |
|
6,100.9 |
Category: Earnings
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