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United Therapeutics 8-K Report, Financial Results (Feb 21, 2024)

Reports
Earnings & Results·Regulation FD·Exhibits & Filings
Filing Date
Filed February 21, 2024
Period End
February 21, 2024
Security
UTHR
In the record · 2016–202610-K1110-Q338-K152

UTHR filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 152 current reports (8-K) between 2016 and 2026.

  1. Leadership change8-K · Jun ’18Jun ’18
  2. Change in control8-K · Jun ’20Jun ’20
  3. Leadership change8-K · Jun ’22Jun ’22
  4. Material agreement8-K · Sep ’26Sep ’26

01—Abstract

Summary

Summary of the 8-K filed February 21, 2024. Cited figures are marked; the original filing is the authoritative source.

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported record full-year 2023 total revenues of $2.33 billiona (2023: $2,327.5 million vs. 2022: $1,936.3 million), up 20%.

Net income for the year was $984.8 millionb, or $19.81 per diluted share, compared with $727.3 million, or $15.00 per diluted share, in 2022. For the fourth quarter, total revenues were $614.7 million, up from $491.5 million, and net income was $217.1 million, or $4.36 per diluted share. The company cited its third straight quarter and second straight year of record revenue, with Tyvaso DPI and total Tyvaso sales as the main drivers.

Total Tyvaso revenues rose 41% for the full year to $1,233.7 million, and Tyvaso DPI revenues increased to $731.1 millionc from $158.3 million. The filing also reports operating expense trends. Research and development expense rose to $408.0 million for 2023, driven by the IVIVA acquisition's in-process R&D charge of $46.0 million, the TETON 1 and TETON 2 studies of nebulized Tyvaso in idiopathic pulmonary fibrosis, and organ manufacturing projects.

Cash, cash equivalents and marketable investments were $4,903.9 milliond at December 31, 2023, compared with $4,154.9 million a year earlier. Management also highlighted the FDA clearance of the miroliverELAP first-in-human study. Separately, the company disclosed that it had commenced litigation against the U.S. Food and Drug Administration over the agency's handling of Liquidia Technologies' amendment to its pending New Drug Application for inhaled treprostinil for PH-ILD.

United Therapeutics argues that Liquidia should have filed a new NDA, which would have triggered a potential 30-month stay tied to its pending patent infringement case over U.S. Patent No. 11,826,327. The patent case is pending in the U.S. District Court for the District of Delaware.

02—Key points

Key Highlights

  1. Record full-year 2023 total revenues of $2,327.5 million, up from $1,936.3 million in 2022, a 20% increase.
  2. Fourth-quarter 2023 total revenues of $614.7 million, up from $491.5 million, with net income of $217.1 million ($4.36 per diluted share).
  3. Full-year 2023 net income of $984.8 million, or $19.81 per diluted share, versus $727.3 million, or $15.00 per diluted share, in 2022.
  4. Total Tyvaso revenues grew 41% to $1,233.7 million in 2023, led by Tyvaso DPI, which reached $731.1 million from $158.3 million.
  5. Research and development expense rose to $408.0 million for 2023, including $46.0 million of in-process R&D expense from the IVIVA Medical acquisition.
  6. Cash, cash equivalents and marketable investments reached $4,903.9 million at December 31, 2023, up from $4,154.9 million at December 31, 2022.
  7. Litigation filed against the FDA over its handling of Liquidia's PH-ILD NDA amendment, seeking to preserve a potential 30-month stay tied to the pending '327 patent infringement case.

03—Questions

Frequently Asked Questions

  1. How did United Therapeutics perform financially in 2023?

    The company reported record total revenues of $2,327.5 million for 2023, up 20% from $1,936.3 million in 2022. Net income rose to $984.8 million, or $19.81 per diluted share, from $727.3 million, or $15.00 per diluted share, a year earlier.

  2. What drove revenue growth?

    Total Tyvaso revenues increased 41% to $1,233.7 million, driven mainly by Tyvaso DPI, which was commercially launched in June 2022 and generated $731.1 million in 2023. Orenitram revenues rose 11% to $359.4 million, and Unituxin revenues rose 9% to $198.9 million. Remodulin revenues declined 1% to $494.8 million.

  3. What is the lawsuit against the FDA about?

    United Therapeutics alleges that the FDA allowed Liquidia to file an amendment to its pending NDA for inhaled treprostinil, rather than a new NDA, for a PH-ILD indication. The company argues that a new NDA would have triggered a potential 30-month stay of approval pending resolution of its patent infringement claim, which is pending in the U.S. District Court for the District of Delaware.

  4. What drove higher research and development spending?

    R&D expense increased to $408.0 million in 2023 from $322.9 million in 2022. The filing attributes the increase to IPR&D expense from the IVIVA Medical acquisition, expenditures on the TETON 1 and TETON 2 studies of nebulized Tyvaso in idiopathic pulmonary fibrosis, and organ manufacturing projects.

  5. What was the company's liquidity position at year-end 2023?

    Cash, cash equivalents and marketable investments totaled $4,903.9 million at December 31, 2023, up from $4,154.9 million at December 31, 2022. Total stockholders' equity was $5,984.8 million, compared with $4,796.7 million a year earlier.

04—Continue

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