United Therapeutics Corporation Reports Fourth Quarter and Full Year 2021 Financial Results
United Therapeutics (Nasdaq: UTHR) reported a significant revenue increase of 14% for the full year 2021, totaling $1,686 million, driven by strong patient growth in treprostinil-based therapies. The company aims to reach 6,000 patients using Tyvaso by the end of 2022. A major amendment to the Tyvaso DPI NDA has postponed the FDA decision to May 2022. The net income for 2021 was $475.8 million, down from $514.8 million in 2020. Non-GAAP earnings per diluted share increased to $15.26 from $14.46 in the previous year.
- Revenue growth of 14% year-over-year, reaching $1,686 million.
- Expansion of Tyvaso label to include PH-ILD, enhancing market potential.
- Strong patient growth, with a target of 6,000 patients using Tyvaso by end of 2022.
- Net income decreased from $514.8 million in 2020 to $475.8 million in 2021.
- Remodulin revenue declined by 1% due to lower quantities sold in the U.S.
Double-digit percentage revenue and patient count growth in full-year 2021
Company reaffirms target to reach 6,000 patients with Tyvaso by the end of 2022
Major amendment to Tyvaso DPI™ NDA pushes FDA decision date to
“We continue to make strong progress with patient growth as we march toward our target of reaching 25,000 patients with our therapies by the end of 2025,” said
“Our commercial teams continue to perform with double-digit percentage growth in revenue and patient counts in 2021 compared to 2020,” said
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS
Key financial highlights include (in millions, except per share data):
|
Three Months Ended
|
|
Year Ended
|
||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||
|
|
|
|
|
|
|
|
||||
Revenues |
$ |
415.2 |
|
$ |
384.9 |
|
$ |
1,685.5 |
|
$ |
1,483.3 |
Net income |
$ |
112.2 |
|
$ |
98.8 |
|
$ |
475.8 |
|
$ |
514.8 |
Non-GAAP earnings(1) |
$ |
168.0 |
|
$ |
149.3 |
|
$ |
721.6 |
|
$ |
644.7 |
Net income, per basic share |
$ |
2.49 |
|
$ |
2.22 |
|
$ |
10.60 |
|
$ |
11.65 |
Net income, per diluted share |
$ |
2.35 |
|
$ |
2.19 |
|
$ |
10.06 |
|
$ |
11.54 |
Non-GAAP earnings, per diluted share(1) |
$ |
3.51 |
|
$ |
3.31 |
|
$ |
15.26 |
|
$ |
14.46 |
(1) |
See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below. |
Revenues
The table below summarizes the components of total revenues (dollars in millions):
|
Three Months Ended
|
|
Dollar Change |
|
Percentage Change |
|
Year Ended
|
|
Dollar Change |
|
Percentage Change |
||||||||||||||
|
2021 |
|
2020 |
|
|
|
2021 |
|
2020 |
|
|
||||||||||||||
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Tyvaso® |
$ |
166.5 |
|
$ |
131.7 |
|
$ |
34.8 |
|
|
26 |
% |
|
$ |
607.5 |
|
$ |
483.3 |
|
$ |
124.2 |
|
|
26 |
% |
Remodulin® |
|
118.3 |
|
|
127.9 |
|
|
(9.6 |
) |
|
(8 |
)% |
|
|
513.7 |
|
|
516.7 |
|
|
(3.0 |
) |
|
(1 |
)% |
Orenitram® |
|
72.3 |
|
|
74.0 |
|
|
(1.7 |
) |
|
(2 |
)% |
|
|
306.1 |
|
|
293.1 |
|
|
13.0 |
|
|
4 |
% |
Unituxin® |
|
50.0 |
|
|
29.7 |
|
|
20.3 |
|
|
68 |
% |
|
|
202.3 |
|
|
122.9 |
|
|
79.4 |
|
|
65 |
% |
Adcirca® |
|
8.1 |
|
|
21.6 |
|
|
(13.5 |
) |
|
(63 |
)% |
|
|
55.9 |
|
|
67.3 |
|
|
(11.4 |
) |
|
(17 |
)% |
Total revenues |
$ |
415.2 |
|
$ |
384.9 |
|
$ |
30.3 |
|
|
8 |
% |
|
$ |
1,685.5 |
|
$ |
1,483.3 |
|
$ |
202.2 |
|
|
14 |
% |
Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by
Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by
Expenses
Cost of product sales. The table below summarizes cost of product sales by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar Change |
|
Percentage Change |
|
Year Ended
|
|
Dollar Change |
|
Percentage Change |
||||||||||||||
|
2021 |
|
2020 |
|
|
|
2021 |
|
2020 |
|
|
||||||||||||||
Category: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales |
$ |
32.8 |
|
$ |
30.4 |
|
$ |
2.4 |
|
|
8 |
% |
|
$ |
116.7 |
|
$ |
101.0 |
|
$ |
15.7 |
|
|
16 |
% |
Share-based compensation expense(1) |
|
1.8 |
|
|
4.4 |
|
|
(2.6 |
) |
|
(59 |
)% |
|
|
5.8 |
|
|
7.1 |
|
|
(1.3 |
) |
|
(18 |
)% |
Total cost of product sales |
$ |
34.6 |
|
$ |
34.8 |
|
$ |
(0.2 |
) |
|
(1 |
)% |
|
$ |
122.5 |
|
$ |
108.1 |
|
$ |
14.4 |
|
|
13 |
% |
(1) Refer to Share-based compensation below. |
Cost of product sales, excluding share-based compensation. The increase in cost of product sales for the year ended
Research and development expense. The table below summarizes research and development expense by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar Change |
|
Percentage Change |
|
Year Ended
|
|
Dollar Change |
|
Percentage Change |
||||||||||||||
|
2021 |
|
2020 |
|
|
|
2021 |
|
2020 |
|
|
||||||||||||||
Category: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development projects |
$ |
75.5 |
|
$ |
109.5 |
|
$ |
(34.0 |
) |
|
(31 |
)% |
|
$ |
515.7 |
|
$ |
328.2 |
|
$ |
187.5 |
|
|
57 |
% |
Share-based compensation expense(1) |
|
7.4 |
|
|
16.6 |
|
|
(9.2 |
) |
|
(55 |
)% |
|
|
24.4 |
|
|
29.5 |
|
|
(5.1 |
) |
|
(17 |
)% |
Total research and development expense |
$ |
82.9 |
|
$ |
126.1 |
|
$ |
(43.2 |
) |
|
(34 |
)% |
|
$ |
540.1 |
|
$ |
357.7 |
|
$ |
182.4 |
|
|
51 |
% |
(1) Refer to Share-based compensation below. |
Research and development expense, excluding share-based compensation. The decrease in research and development expense for the quarter ended
The increase in research and development expense for the year ended
Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar Change |
|
Percentage Change |
|
Year Ended
|
|
Dollar Change |
|
Percentage Change |
||||||||||||||
|
2021 |
|
2020 |
|
|
|
2021 |
|
2020 |
|
|
||||||||||||||
Category: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
General and administrative |
$ |
76.0 |
|
$ |
69.2 |
|
$ |
6.8 |
|
|
10 |
% |
|
$ |
294.3 |
|
$ |
241.8 |
|
$ |
52.5 |
|
|
22 |
% |
Sales and marketing |
|
16.4 |
|
|
16.8 |
|
|
(0.4 |
) |
|
(2 |
)% |
|
|
64.4 |
|
|
54.9 |
|
|
9.5 |
|
|
17 |
% |
Share-based compensation expense(1) |
|
35.5 |
|
|
72.7 |
|
|
(37.2 |
) |
|
(51 |
)% |
|
|
108.3 |
|
|
127.2 |
|
|
(18.9 |
) |
|
(15 |
)% |
Total selling, general, and administrative expense |
$ |
127.9 |
|
$ |
158.7 |
|
$ |
(30.8 |
) |
|
(19 |
)% |
|
$ |
467.0 |
|
$ |
423.9 |
|
$ |
43.1 |
|
|
10 |
% |
(1) Refer to Share-based compensation below. |
General and administrative, excluding share-based compensation. The increase in general and administrative expense for the year ended
Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):
|
Three Months Ended
|
|
Dollar Change |
|
Percentage Change |
|
Year Ended
|
|
Dollar Change |
|
Percentage Change |
||||||||||||||
|
2021 |
|
2020 |
|
|
|
2021 |
|
2020 |
|
|
||||||||||||||
Category: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Stock options |
$ |
5.6 |
|
$ |
9.2 |
|
$ |
(3.6 |
) |
|
(39 |
) % |
|
$ |
25.4 |
|
$ |
44.0 |
|
$ |
(18.6 |
) |
|
(42 |
)% |
Restricted stock units |
|
6.3 |
|
|
5.5 |
|
|
0.8 |
|
|
15 |
% |
|
|
24.7 |
|
|
20.5 |
|
|
4.2 |
|
|
20 |
% |
Share tracking awards plan (STAP) |
|
32.3 |
|
|
78.5 |
|
|
(46.2 |
) |
|
(59 |
)% |
|
|
86.6 |
|
|
97.8 |
|
|
(11.2 |
) |
|
(11 |
)% |
Employee stock purchase plan |
|
0.5 |
|
|
0.5 |
|
|
— |
|
|
— |
% |
|
|
1.8 |
|
|
1.5 |
|
|
0.3 |
|
|
20 |
% |
Total share-based compensation expense |
$ |
44.7 |
|
$ |
93.7 |
|
$ |
(49.0 |
) |
|
(52 |
)% |
|
$ |
138.5 |
|
$ |
163.8 |
|
$ |
(25.3 |
) |
|
(15 |
)% |
The decrease in share-based compensation expense for the quarter and year ended
Other (expense) income, net. The changes in other (expense) income, net for the quarter and year ended
Income tax expense. Income tax expense was
Non-GAAP Earnings
Non-GAAP earnings is defined as net income, adjusted for: (1) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards, and our employee stock purchase plan); (2) unrealized gains on investments in privately-held companies; (3) impairment charges; (4) license-related fees; (5) net changes in recurring fair value measurements; (6) certain other costs incurred outside our normal course of business; and (7) tax impact on non-GAAP earnings adjustments.
A reconciliation of net income to non-GAAP earnings is presented below (in millions, except per share data):
|
Three Months Ended
|
|
Year Ended
|
||||||||||||
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Net income, as reported |
$ |
112.2 |
|
|
$ |
98.8 |
|
|
$ |
475.8 |
|
|
$ |
514.8 |
|
Adjusted for the following charges: |
|
|
|
|
|
|
|
||||||||
Share-based compensation expense(1) |
|
44.7 |
|
|
|
93.7 |
|
|
|
138.5 |
|
|
|
163.8 |
|
Unrealized gains on investments in privately-held companies(2) |
|
— |
|
|
|
(0.7 |
) |
|
|
— |
|
|
|
(25.5 |
) |
Impairment charges(3) |
|
1.0 |
|
|
|
— |
|
|
|
134.9 |
|
|
|
16.0 |
|
License-related fees(4) |
|
2.0 |
|
|
|
17.5 |
|
|
|
3.0 |
|
|
|
33.6 |
|
Net changes in recurring fair value measurements(5) |
|
28.6 |
|
|
|
(43.7 |
) |
|
|
(44.2 |
) |
|
|
(25.7 |
) |
Other(6) |
|
— |
|
|
|
— |
|
|
|
105.0 |
|
|
|
— |
|
Tax benefit |
|
(20.5 |
) |
|
|
(16.3 |
) |
|
|
(91.4 |
) |
|
|
(32.3 |
) |
Non-GAAP earnings |
$ |
168.0 |
|
|
$ |
149.3 |
|
|
$ |
721.6 |
|
|
$ |
644.7 |
|
Non-GAAP earnings per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
3.73 |
|
|
$ |
3.36 |
|
|
$ |
16.07 |
|
|
$ |
14.59 |
|
Diluted |
$ |
3.51 |
|
|
$ |
3.31 |
|
|
$ |
15.26 |
|
|
$ |
14.46 |
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
45.1 |
|
|
|
44.5 |
|
|
|
44.9 |
|
|
|
44.2 |
|
Diluted |
|
47.8 |
|
|
|
45.1 |
|
|
|
47.3 |
|
|
|
44.6 |
|
(1) |
Recorded within operating expenses in our consolidated statements of operations. |
(2) |
Recorded within other (expense) income, net in our consolidated statements of operations. |
(3) |
For the quarter ended |
(4) |
Recorded within research and development in our consolidated statements of operations. |
(5) |
Net changes in the fair values of our contingent consideration liabilities were recorded within research and development in our consolidated statements of operations and net changes in all other recurring fair value measurements were recorded within other (expense) income, net in our consolidated statements of operations. |
(6) |
For the year ended |
PRODUCT COMMERCIALIZATION UPDATE
In 2021, we launched one new product and one new product indication. In
Remunity Pump for Remodulin. In
Tyvaso Inhalation Solution in PH-ILD. The FDA approved Tyvaso for the PH-ILD indication on
Tyvaso DPI™. In
We resubmitted our NDA in
Our Tyvaso DPI NDA includes the results of two clinical studies we conducted of Tyvaso DPI. One was a study in healthy volunteers, comparing the pharmacokinetics of Tyvaso DPI to Tyvaso Inhalation Solution. The study was completed in
RESEARCH AND DEVELOPMENT UPDATE
Updates on select later-stage programs are below.
Tyvaso in chronic fibrosing interstitial lung diseases — TETON 1 and TETON 2. We are enrolling a phase 3 study called TETON 1, which is a
The TETON program was prompted by data from the INCREASE study, which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease. Specifically, in the INCREASE study, treatment with Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having underlying etiologies of idiopathic interstitial pneumonias showing greater improvement. Consistent positive effects were also observed in patients with chronic hypersensitivity pneumonitis and environmental/occupational lung disease. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that Tyvaso may offer a treatment option for patients with fibrotic lung disease.
Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study evaluating Tyvaso in patients with
Ralinepag phase 3 clinical studies — ADVANCE CAPACITY and ADVANCE OUTCOMES. We are enrolling two phase 3 clinical studies to support the potential approval of oral ralinepag for PAH.
INDUCEMENT RESTRICTED STOCK UNITS
On
WEBCAST
We will host a webcast to discuss our fourth quarter and full year 2021 financial results on
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
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. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
You can learn more about what it means to be a PBC here: unither.com/PBC.
NON-GAAP FINANCIAL INFORMATION
This press release contains a financial measure, non-GAAP earnings, which does not comply with
We use non-GAAP earnings to assist us in: (1) planning, including the preparation of our annual operating budget; (2) allocating resources in an effort to enhance the financial performance of our business; (3) evaluating the effectiveness of our operational strategies; and (4) assessing our capacity to fund capital expenditures and expand our business. We believe this non-GAAP financial measure improves investors’ understanding of our financial results by providing greater transparency with respect to the information our management uses to evaluate and compare the performance of our core operations and make operating decisions. This non-GAAP financial measure enables investors to see our business through the eyes of our management. However, there are limitations in the use of this non-GAAP financial measure in that it excludes certain operating expenses that are recurring in nature. In addition, our calculation of this non-GAAP financial measure may differ from the methodology used by other companies. The presentation of this non-GAAP financial measure should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP. A reconciliation of net income, the most directly comparable GAAP financial measure, to non-GAAP earnings can be found in the table above under the heading, Non-GAAP Earnings.
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 revenue growth prospects, our goals of reaching 6,000
ORENITRAM, REMODULIN, REMUNITY, TYVASO, and UNITUXIN are registered trademarks of
TYVASO DPI and UHEART 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
|
|
Year Ended
|
||||||||||||
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product sales |
$ |
415.2 |
|
|
$ |
384.9 |
|
|
$ |
1,685.5 |
|
|
$ |
1,483.3 |
|
Total revenues |
|
415.2 |
|
|
|
384.9 |
|
|
|
1,685.5 |
|
|
|
1,483.3 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of product sales |
|
34.6 |
|
|
|
34.8 |
|
|
|
122.5 |
|
|
|
108.1 |
|
Research and development |
|
82.9 |
|
|
|
126.1 |
|
|
|
540.1 |
|
|
|
357.7 |
|
Selling, general, and administrative |
|
127.9 |
|
|
|
158.7 |
|
|
|
467.0 |
|
|
|
423.9 |
|
Total operating expenses |
|
245.4 |
|
|
|
319.6 |
|
|
|
1,129.6 |
|
|
|
889.7 |
|
Operating income |
|
169.8 |
|
|
|
65.3 |
|
|
|
555.9 |
|
|
|
593.6 |
|
Interest income |
|
4.2 |
|
|
|
5.0 |
|
|
|
16.7 |
|
|
|
28.6 |
|
Interest expense |
|
(4.7 |
) |
|
|
(4.8 |
) |
|
|
(18.6 |
) |
|
|
(23.5 |
) |
Other (expense) income, net |
|
(28.8 |
) |
|
|
48.9 |
|
|
|
42.2 |
|
|
|
49.3 |
|
Impairments of investments in privately-held companies |
|
— |
|
|
|
— |
|
|
|
(2.3 |
) |
|
|
(9.1 |
) |
Total other (expense) income, net |
|
(29.3 |
) |
|
|
49.1 |
|
|
|
38.0 |
|
|
|
45.3 |
|
Income before income taxes |
|
140.5 |
|
|
|
114.4 |
|
|
|
593.9 |
|
|
|
638.9 |
|
Income tax expense |
|
(28.3 |
) |
|
|
(15.6 |
) |
|
|
(118.1 |
) |
|
|
(124.1 |
) |
Net income |
$ |
112.2 |
|
|
$ |
98.8 |
|
|
$ |
475.8 |
|
|
$ |
514.8 |
|
Net income per common share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
2.49 |
|
|
$ |
2.22 |
|
|
$ |
10.60 |
|
|
$ |
11.65 |
|
Diluted |
$ |
2.35 |
|
|
$ |
2.19 |
|
|
$ |
10.06 |
|
|
$ |
11.54 |
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
45.1 |
|
|
|
44.5 |
|
|
|
44.9 |
|
|
|
44.2 |
|
Diluted |
|
47.8 |
|
|
|
45.1 |
|
|
|
47.3 |
|
|
|
44.6 |
|
SELECTED CONSOLIDATED BALANCE SHEET DATA (In millions) |
||||||
|
|
|||||
|
2021 |
|
2020 |
|||
Cash, cash equivalents, and marketable investments |
$ |
3,580.6 |
|
$ |
2,984.6 |
|
Total assets |
|
5,169.1 |
|
|
4,615.0 |
|
Total liabilities |
|
1,210.2 |
|
|
1,219.8 |
|
Total stockholders' equity |
|
3,958.9 |
|
|
3,395.2 |
Category: Earnings
View source version on businesswire.com: https://www.businesswire.com/news/home/20220224005194/en/
Phone: (202) 919-4097
Email: ir@unither.com
Source:
FAQ
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