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UTHR · United Therapeutics

344 filings

8-K

UTHR 8-K Current Reports

United Therapeutics - 344 current reports

Filing 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. Material agreement8-K · May ’17May ’17
  2. Leadership change8-K · Jun ’19Jun ’19
  3. Material agreement8-K · Apr ’22Apr ’22
  4. Leadership change8-K · Jan ’26Jan ’26
Showing 1-50 of 344 filings
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Nov 4, 2026)

Nov 4, 2026
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Oct 22, 2026)

United Therapeutics Corporation's Board of Directors approved a new share repurchase program on October 21, 2026, authorizing the purchase of up to $2.0 billion of the Company's common stock. The authorization remains in effect for one year, through October 21, 2027. The Company announced the program in a press release dated October 22, 2026, filed as Exhibit 99.1. Per the press release, repurchases may be made through accelerated share repurchase programs, open market transactions, privately negotiated transactions or other means. The program does not require any minimum number of purchases, and the Company may commence or suspend purchases at any time without prior notice and assumes no obligation to use the authorization. Repurchases will depend on alternative uses of capital, market conditions and other factors. CFO James Edgemond said the authorization reflects the balance sheet, free cash flow and confidence to act when the Company's own shares represent a compelling investment. The Company also has an ongoing accelerated share repurchase (ASR) transaction, entered into in September 2026 under its prior authorization, with a scheduled termination date in the fourth quarter of 2026. The press release states that this ASR will not reduce the amount available under the new $2 billion authorization.

Oct 22, 2026
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Oct 14, 2026)

United Therapeutics Corporation (UT) entered into a Settlement Agreement dated October 13, 2026 with Liquidia Technologies, Inc. (Liquidia) to resolve multiple pending patent and trade secret litigations between the parties. Under the agreement, Liquidia will pay UT an aggregate of $330.4 million: $185 million as an estimate of damages for past sales of Yutrepia for PH-ILD, due within 30 business days, and $145.4 million for continuing PH-ILD sales, payable in two equal installments of $72.7 million on or before January 31, 2027 and April 30, 2027. UT will pay Liquidia $10.0 million to resolve a related case brought by Sandoz and RareGen. The parties agreed to seek dismissal with prejudice of the covered actions, with UT retaining its trade secret claims against former Liquidia executive Dr. Robert Roscigno. Liquidia must file with the FDA to remove the PH-ILD indication from Yutrepia's labeling and must cease PH-ILD marketing immediately, with sales of PH-ILD-indicated product ceasing upon FDA approval of the label amendment. Liquidia also agreed to new promotional restrictions, patient-referral certification requirements, termination of PH-ILD cohorts in its ASCENT trial, and covenants not to sue and not to challenge certain UT patents. Releases take effect only after UT receives the $185 million payment, receives an officer's declaration that Liquidia has ceased marketing the PH-ILD-indicated product, and the cases are dismissed. Separately, the filing describes an October 7, 2026 Third Circuit decision in the RareGen/Sandoz antitrust and contract litigation. The court affirmed summary judgment for UT on the antitrust and state unfair competition claims, but reversed the summary judgment on the Sandoz breach of contract claim, vacated the prior $61.6 million damages award, and remanded the contract and tortious interference claims for further proceedings. The settlement resolves all claims in that litigation.

Oct 14, 2026
8-K
Material AgreementsRegulation FDExhibits & Filings

United Therapeutics 8-K Report, Material Agreement (Sep 8, 2026)

On September 8, 2026, United Therapeutics Corporation (UTHR) entered into an accelerated share repurchase (ASR) agreement with Citibank, N.A. to repurchase approximately $477.6 million of its common stock. The company is making an aggregate upfront payment of about $477.6 million to Citi on or around September 10, 2026, and will receive an initial delivery of approximately 719,376 shares, representing about 75% of the shares anticipated to be repurchased based on the September 8, 2026 closing price. The final share count will depend on the average daily VWAP of the common stock over the ASR term, less a discount, and final settlement is expected in the fourth quarter of 2026. The transaction completes the remainder of the company's previously announced $2 billion share repurchase authorization. According to the accompanying press release, the company previously entered into ASR agreements totaling $1.5 billion in March 2026 and bought an additional $22.4 million in open-market transactions during the third quarter of 2026. Chairperson and CEO Martine Rothblatt stated that upon completion of this repurchase the company will have returned $4 billion to shareholders in approximately 2.5 years. The press release also states that the company had approximately 42.9 million shares outstanding as of September 4, 2026. At final settlement, the company may receive additional shares or, in limited circumstances, make a cash payment to Citi, or deliver shares if it elects. The Item 7.01 disclosure and Exhibit 99.1 are furnished rather than filed under the Exchange Act.

Sep 8, 2026
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Aug 5, 2026)

United Therapeutics Corporation reported second quarter 2026 financial results in a press release attached as Exhibit 99.1 to this Form 8-K. Total revenues were $783.3 million, down two percent from $798.6 million in the second quarter of 2025. Net income rose eight percent to $333.0 million, and diluted earnings per share were $7.27, up 13 percent. The decline in revenue was driven by Nebulized Tyvaso, which fell to $126.0 million from $154.4 million, partially offset by growth in Tyvaso DPI, which rose four percent to $326.6 million. The company attributed weakness in Tyvaso, Remodulin and Nebulized Tyvaso sales to the availability of competitive therapies. Cost of sales included $7.5 million of estimated losses under a commercial supply agreement intended to supply sufficient Tyvaso DPI inventory. Management highlighted regulatory progress. The company stated it has submitted new drug applications for ralinepag tablets in PAH and Nebulized Tyvaso in IPF, and it expects potential approvals of both next year. It also plans to file an IND application for ralinepag DPI and an NDA for treprostinil SMI later this year. The CEO described these programs as potential multi-billion-dollar catalysts. Income tax expense fell to $39.7 million, with an effective tax rate of 11 percent versus 24 percent a year earlier, which management attributed primarily to increased excess tax benefits from share-based compensation. On capital allocation, the company entered into two accelerated share repurchase agreements with Citibank, N.A. in March 2026 for approximately $1.5 billion of common stock. One agreement settled during the quarter and the other settled in August 2026, with 2,759,343 shares repurchased in total. As of June 30, 2026, $500 million remained under the $2.0 billion repurchase program, which expires March 9, 2027. Cash, cash equivalents and marketable investments totaled $3,803.4 million at quarter end.

Aug 5, 2026
8-K
Leadership ChangesRegulation FDExhibits & Filings

United Therapeutics 8-K Report, Executive Changes (Jul 23, 2026)

United Therapeutics Corporation (Nasdaq: UTHR) filed this Current Report on Form 8-K dated July 23, 2026, to report the appointment of Victor Dzau, M.D., to its Board of Directors. The Board, acting on the recommendation of its Nominating and Governance Committee, increased the Board size to 13 members and appointed Dr. Dzau effective July 22, 2026. The Board determined he will not initially serve on any Board committee. In connection with his appointment, Dr. Dzau received equity awards under the 2026 Stock Incentive Plan on July 22, 2026: an initial grant of 380 restricted stock units and 1,190 stock options, plus pro-rata grants of 350 restricted stock units and 1,110 stock options for the remainder of the 2026-2027 Board service year. He also entered into the Company's standard director and executive officer indemnification agreement, and will receive further compensation under the Director Compensation Program described in the April 29, 2026 proxy statement. The filing states there are no related-party transactions above $120,000 involving Dr. Dzau and no arrangement under which he was selected. The filing is largely governance-related. Exhibit 99.1, a press release dated July 23, 2026, describes Dr. Dzau's background, including his recent 12-year tenure as President of the National Academy of Medicine, which ended in June 2026, and his return to Duke University. The release also quotes Chairperson and CEO Martine Rothblatt and Nominating and Governance Committee Chairperson Christopher Causey, who described the appointment as part of an ongoing Board refreshment effort. Item 7.01 information is furnished rather than filed.

Jul 23, 2026
8-K
Leadership ChangesShareholder MattersExhibits & Filings

United Therapeutics 8-K Report, Executive Changes (Jun 29, 2026)

On June 26, 2026, United Therapeutics Corporation's shareholders held the 2026 Annual Meeting and approved the United Therapeutics Corporation 2026 Stock Incentive Plan (the 2026 Plan), which takes effect that day. The 2026 Plan is administered by the Compensation Committee, is composed of independent directors, and allows grants of stock options, stock appreciation rights, restricted stock, restricted stock units, stock awards (any of which may be performance-based), and incentive bonuses. The plan reserves 1,500,000 new shares plus the shares remaining available under the Prior Plan (2,413,730 shares as of June 26, 2026), along with certain shares subject to outstanding Prior Plan awards that later lapse or are settled in cash. The Company will make no further grants under the Amended and Restated 2015 Stock Incentive Plan, though outstanding awards under it (4,941,655 shares as of June 26, 2026) remain in effect. At the meeting, all eleven director nominees were elected to one-year terms, though several received substantially more votes against than others, with Christopher Causey, Richard Giltner, and Christopher Patusky each receiving over 3,000,000 votes against. The advisory resolution on executive compensation received 35,152,059 votes for and 1,048,505 against. Shareholders also ratified Ernst & Young LLP as the independent registered public accounting firm for 2026, with 35,753,887 votes for and 1,647,415 against. The 2026 Plan was the most contested proposal, receiving 25,872,075 votes for, 10,070,290 against, and 276,512 abstentions, plus 1,194,857 broker non-votes. The 8-K is largely a governance filing. Investors evaluating dilution should note the new share reserve and the Compensation Committee's administration of the plan. Full plan terms are in Exhibit 10.1, and additional detail is in the Company's April 29, 2026 proxy statement under Proposal No. 3.

Jun 29, 2026
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (May 6, 2026)

United Therapeutics Corporation (Nasdaq: UTHR) furnished an 8-K on May 6, 2026 under Item 2.02 (Results of Operations and Financial Condition), attaching Exhibit 99.1, a press release reporting first quarter 2026 results for the quarter ended March 31, 2026. Total revenues decreased two percent year-over-year to $781.5 million from $794.4 million, and net income fell 15 percent to $274.9 million from $322.2 million. Diluted earnings per share were $5.82 versus $6.63, a 12 percent decline. Management pointed to positive ADVANCE OUTCOMES and TETON-1 study results and announced development plans for ralinepag DPI in pulmonary hypertension and fibrosis. The revenue decline was driven by Nebulized Tyvaso, which fell 22 percent to $127.2 million on lower U.S. quantities sold, partially offset by Tyvaso DPI growth of nine percent to $330.3 million and Orenitram growth of 12 percent to $135.6 million. Cost of sales rose 44 percent to $133.4 million, mainly from higher inventory reserve expense, of which $26.8 million relates to an estimated loss from a commercial supply agreement for Tyvaso DPI inventory. Income tax expense was $43.4 million, with an effective tax rate of 14 percent versus 24 percent a year earlier, which management attributed primarily to increased excess tax benefits from share-based compensation. Capital allocation was also active: in March 2026 the Board approved a share repurchase program of up to $2.0 billion expiring March 9, 2027, and the company entered into accelerated share repurchase agreements with Citibank, N.A. for approximately $1.5 billion of common stock, with $500 million remaining under the authorization as of March 31, 2026. Cash, cash equivalents and marketable investments totaled $3,471.1 million at quarter end, against total assets of $6,714.2 million and stockholders' equity of $5,901.1 million.

May 6, 2026
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Mar 30, 2026)

On March 30, 2026, United Therapeutics Corporation (Nasdaq: UTHR) announced that its TETON-1 pivotal phase 3 study of nebulized Tyvaso (treprostinil) Inhalation Solution in idiopathic pulmonary fibrosis (IPF) met its primary endpoint. Nebulized Tyvaso demonstrated superiority over placebo for the change in absolute forced vital capacity (FVC) of 130.1 mL (Hodges-Lehmann estimate, 95% CI 82.2 to 178.1 mL; p<0.0001) from baseline to week 52. The study also achieved statistical significance in reducing the risk of clinical worsening, and showed numerical improvement in other secondary endpoints, including time to first acute exacerbation of IPF. The safety profile was described as consistent with prior Tyvaso studies, with no new safety signals. Integrated analyses of TETON-1 and TETON-2 showed a statistically significant treatment effect on the primary endpoint of 111.8 mL change in absolute FVC (95% CI 79.7 to 144.0; p<0.0001) and on most secondary endpoints. Overall survival at week 52 trended in favor of Tyvaso but did not reach statistical significance. The company plans to seek priority review of a supplemental New Drug Application, to be submitted to the FDA by the end of summer 2026, to add IPF to Tyvaso's labeled indications. Additional data will be presented at the American Thoracic Society Annual Meeting in May 2026, and the TETON-PPF study in progressive pulmonary fibrosis is ongoing. The filing is an Item 8.01 (Other Events) report furnishing the press release as Exhibit 99.1. The company's CEO described the results as an inflection point, noting that three pivotal studies (TETON-1, TETON-2, and ADVANCE OUTCOMES for ralinepag) met their primary endpoints in the past seven months.

Mar 30, 2026
8-K
Material AgreementsRegulation FDExhibits & Filings

United Therapeutics 8-K Report, Material Agreement (Mar 9, 2026)

On March 9, 2026, United Therapeutics Corporation's Board had approved a share repurchase program authorizing up to $2.0 billion of common stock purchases before March 9, 2027. The same day, the company entered into two accelerated share repurchase (ASR) agreements with Citibank, N.A. totaling approximately $1.5 billion: a $750 million uncollared ASR and a $750 million collared ASR. The company will make an aggregate upfront payment of $1.5 billion to Citi on or before March 11, 2026, and will receive initial share deliveries on that date of approximately 992,120 shares (Uncollared ASR, about 70% of the expected total) and approximately 708,657 shares (Collared ASR, about 50% of the expected total), measured at the March 9, 2026 closing price. The final share count for each ASR will depend on the average daily volume-weighted average price over the term, less a discount, with the Uncollared ASR scheduled to terminate in the second quarter of 2026 and the Collared ASR in the third quarter of 2026. The Collared ASR includes a collar setting minimum and maximum share amounts, and at final settlement the company may receive additional shares or, in limited circumstances, owe cash or elect to deliver shares to Citi. In the accompanying press release, Chairperson and CEO Martine Rothblatt described the repurchase as a value-enhancing use of capital and said the company has a robust balance sheet. After the initial $1.5 billion ASR, $500 million remains under the authorization for discretionary repurchases over the following year, and the company assumes no obligation to use it.

Mar 9, 2026
8-K
Regulation FDExhibits & Filings

United Therapeutics 8-K Report, Regulation FD Disclosure (Mar 2, 2026)

United Therapeutics Corporation (Nasdaq: UTHR) furnished this Form 8-K under Item 7.01 (Regulation FD Disclosure) to report positive topline results from the phase 3 ADVANCE OUTCOMES study of ralinepag in patients with pulmonary arterial hypertension (PAH). The study met its primary endpoint: ralinepag reduced the risk of a clinical worsening event by 55% compared with placebo (hazard ratio 0.45, 95% CI 0.33-0.62; p<0.0001). The study enrolled 687 patients randomized 1:1, and 80% of patients were on dual background therapy at baseline. The company reported that ralinepag also produced statistically significant improvements versus placebo in several secondary endpoints, including six-minute walk distance, change in NT-proBNP, and clinical improvement, with the odds of clinical improvement increased by 47% from baseline to Week 28 (p=0.015). The company stated that treatment was well-tolerated, with a safety profile consistent with known prostacyclin-related adverse events and no new safety signals. Headache, diarrhea, nausea, myalgia and jaw pain were the most commonly reported adverse events in the presentation, occurring more frequently with ralinepag than placebo. United Therapeutics intends to present full results at an upcoming international conference and to submit a New Drug Application for ralinepag to the FDA by the second half of 2026. The company hosted a webcast at 8:30 a.m. Eastern Time on March 2, 2026, and the investor slides (Exhibit 99.2) were also posted to its website.

Mar 2, 2026
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Feb 25, 2026)

United Therapeutics Corporation furnished an 8-K on February 25, 2026 (Item 2.02, Results of Operations and Financial Condition) attaching a press release reporting its results for the quarter and year ended December 31, 2025. Full year 2025 total revenues rose to a record $3.18 billion ($3,182.7 million), up 11% from $2,877.4 million in 2024. Fourth-quarter revenues were $790.2 million versus $735.9 million a year earlier. Full year 2025 net income was $1,334.7 million, or $27.86 per diluted share, compared with $1,195.1 million, or $24.64 per diluted share, in 2024. Growth was driven by Tyvaso, with total Tyvaso revenues up 16% to $1,878.2 million for 2025, led by Tyvaso DPI, which grew 25% to $1,292.5 million. Nebulized Tyvaso was roughly flat for the year at $585.7 million, while Orenitram grew 14% to $496.9 million. Remodulin and Unituxin declined for the year. Operating expenses rose, with full-year research and development up 14% to $550.0 million and selling, general, and administrative expense up 6% to $755.8 million, which included a $21.7 million PP&E impairment in the second quarter of 2025. Share repurchases under accelerated share repurchase agreements totaled approximately $1.0 billion in August 2025, and cash, cash equivalents, and marketable investments were $4,697.0 million at year-end. Management highlighted that ADVANCE OUTCOMES and TETON-1 clinical programs are "on the cusp of unveiling pivotal data," and said it expects to continue delivering durable double-digit revenue growth. The company also noted a litigation accrual of $3.0 million in 2025 related to Sandoz Inc., and stated that it does not expect losses in excess of that accrual to be material to its financial results.

Feb 25, 2026
8-K
Leadership ChangesCorporate ChangesRegulation FD+1

United Therapeutics 8-K Report, Executive Changes (Jan 22, 2026)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported in this Form 8-K dated January 22, 2026 that its Board of Directors increased the Board to 13 members and appointed Kevin J. Tracey, M.D., effective January 21, 2026. Dr. Tracey will not initially serve on any Board committee. He received 1,220 restricted stock units under the Company's Amended and Restated 2015 Stock Incentive Plan, granted January 21, 2026, under the standard non-employee director compensation program, and he entered into the Company's standard director and executive officer indemnification agreement. The Board also approved the Eleventh Amended and Restated Bylaws, effective upon Board approval on January 21, 2026. The principal changes add a cure process for certain deficiencies in shareholder director nomination notices, remove language allowing the Board to require a vote larger than a majority of the voting power present for certain matters, and lower the shareholder vote required to alter, repeal, or amend the Bylaws from 80% to a majority of the voting power of outstanding shares entitled to vote generally in director elections, voting as a single class. Other technical conforming changes were also made. The announcement of Dr. Tracey's appointment is furnished under Item 7.01 as Exhibit 99.1 and is not deemed filed for purposes of Section 18 of the Exchange Act. The press release quotes Chairperson and CEO Martine Rothblatt, Ph.D., describing Dr. Tracey as a strategic and scientific addition to the Board as the company advances its rare pulmonary disease pipeline and organ manufacturing programs.

Jan 22, 2026
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Oct 29, 2025)

United Therapeutics Corporation, a public benefit corporation (Nasdaq: UTHR), reported record financial results for the third quarter ended September 30, 2025, in a press release furnished as Exhibit 99.1 under Item 2.02 of this Form 8-K. Total revenues grew seven percent year-over-year to $799.5 million from $748.9 million. Net income was $338.7 million, up 10 percent from $309.1 million, and diluted earnings per share were $7.16, up 12 percent from $6.39. Growth was led by Tyvaso DPI, which rose 22 percent to $336.2 million, and Orenitram, which rose 16 percent to $131.1 million. Total Tyvaso revenues grew 10 percent to $478.0 million, partially offset by a decline in Nebulized Tyvaso and lower Unituxin sales. Operating expenses fell overall, with total selling, general, and administrative expense down 17 percent to $182.6 million, largely because the prior-year period included a $65.1 million litigation accrual related to Sandoz Inc. (the accrual balance was $73.3 million at September 30, 2025). Research and development expense rose 23 percent to $127.5 million, driven by manufactured organ and organ alternative projects and a $5.0 million drug delivery milestone payment. The company's effective tax rate increased to 23 percent from 20 percent. Cash, cash equivalents, and marketable investments totaled $4,334.9 million at quarter-end, against total assets of $7,351.1 million and stockholders' equity of $6,590.2 million. Capital return and pipeline were also highlighted. The company repurchased approximately $1.0 billion of common stock under an accelerated share repurchase agreement with Citibank, N.A. in August 2025, and received 2,638,616 shares under the ASR agreements during the quarter. Management pointed to breakthrough results from the TETON-2 study in idiopathic pulmonary fibrosis as a potential driver of broader therapeutic reach and future growth.

Oct 29, 2025
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Sep 2, 2025)

United Therapeutics Corporation filed this Form 8-K on September 2, 2025 under Item 8.01 (Other Events) to announce positive topline results from its Phase 3 TETON-2 study of nebulized Tyvaso (treprostinil) Inhalation Solution in patients with idiopathic pulmonary fibrosis (IPF). The study met its primary endpoint, showing a superiority over placebo for the change in absolute forced vital capacity (FVC) of 95.6 mL (Hodges-Lehmann estimate, p<0.0001) from baseline to week 52. Benefits were observed across all subgroups, including background therapy, smoking status, and supplemental oxygen use. Statistically significant improvements versus placebo were also seen in most secondary endpoints, including time to first clinical worsening, percent predicted FVC, King's Brief Interstitial Lung Disease (K-BILD) quality of life questionnaire, and diffusion capacity of lungs for carbon monoxide (DLCO). Time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Tyvaso without reaching statistical significance. The company stated the safety profile was consistent with prior Tyvaso studies and no new safety signal was seen. The company intends to use data from TETON-2 and the ongoing TETON-1 study to support a supplemental New Drug Application to add IPF to the labeled indications for nebulized Tyvaso. United Therapeutics plans to meet with the FDA before year-end to discuss ways to potentially expedite review, and TETON-1 data readout is expected in the first half of 2026. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil for IPF. Additional TETON-2 results will be presented at the European Respiratory Society Congress on September 28, 2025.

Sep 2, 2025
8-K
Material AgreementsRegulation FDExhibits & Filings

United Therapeutics 8-K Report, Material Agreement (Aug 1, 2025)

United Therapeutics Corporation (Nasdaq: UTHR) disclosed on August 1, 2025 that it entered into two accelerated share repurchase (ASR) agreements with Citibank, N.A. to repurchase approximately $1 billion in aggregate of its common stock under the $1 billion Share Repurchase Program previously approved by the Board and announced July 30, 2025. The agreements consist of a $500 million uncollared ASR and a $500 million collared ASR, with an aggregate upfront payment of $1 billion to Citi due August 4, 2025. Under the uncollared ASR, the company will receive an initial delivery of approximately 1,274,296 shares on August 4, 2025, representing about 75% of the total shares to be repurchased, with final settlement expected in the fourth quarter of 2025. Under the collared ASR, the company will receive an initial delivery of approximately 849,531 shares, representing about 50% of the total shares to be repurchased, with an additional delivery after a hedging period and final settlement expected in the first quarter of 2026. Final share counts for both agreements depend on the average daily VWAP during the term, less a discount, and the collared ASR includes minimum and maximum share amounts. In the accompanying press release, Chairperson and CEO Martine Rothblatt, Ph.D. said the repurchase reflects confidence in the company's intrinsic value, upcoming catalysts, and ability to generate sustained revenue and cash flow growth, while leaving ample remaining capital on the balance sheet. The release states that approximately 45.2 million shares were outstanding as of July 30, 2025.

Aug 1, 2025
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Jul 30, 2025)

United Therapeutics Corporation furnished an 8-K on July 30, 2025 (Item 2.02) attaching a press release reporting its results for the quarter ended June 30, 2025. Total revenues were $798.6 million, up 12 percent from $714.9 million in the second quarter of 2024, which the company described as a record and its twelfth consecutive quarter of double-digit year-over-year total revenue growth. Net income rose to $309.5 million from $278.1 million (up 11 percent), and diluted earnings per share were $6.41 versus $5.85 (up 10 percent). Growth was led by Tyvaso DPI, with record revenue of $315.2 million (up 22 percent). Total Tyvaso revenue reached $469.6 million (up 18 percent), while Nebulized Tyvaso, Orenitram, and Unituxin each grew double digits. Remodulin revenue declined 9 percent to $134.7 million. Operating expenses included a $21.7 million impairment of property, plant, and equipment within selling, general, and administrative expense. Total research and development expense fell 4 percent to $134.0 million, largely because of $36.0 million in upfront license payments made in the prior-year period. At June 30, 2025, cash, cash equivalents, and marketable investments totaled $4,966.4 million and stockholders' equity was $7,173.6 million. The company also announced that its Board authorized share repurchases of up to $1 billion, expiring March 31, 2026. Management highlighted upcoming catalysts: Phase 3 TETON 2 data for Nebulized Tyvaso in idiopathic pulmonary fibrosis expected in September 2025, Phase 3 TETON 1 data expected in the first half of 2026, and ADVANCE OUTCOMES data for ralinepag in pulmonary arterial hypertension expected in the first half of 2026.

Jul 30, 2025
8-K
Leadership ChangesShareholder MattersExhibits & Filings

United Therapeutics 8-K Report, Executive Changes (Jun 27, 2025)

At its June 26, 2025 Annual Meeting of Shareholders, United Therapeutics Corporation's shareholders approved an amendment and restatement (the 2025 Restatement) of the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the Plan). The Board had previously approved the 2025 Restatement on the recommendation of its Compensation Committee, and it is effective June 26, 2025. The Restatement increases the maximum number of shares of common stock issuable under the Plan by 950,000 shares, extends the Plan's expiration date to April 24, 2035, and raises the Lead Independent Director retainer under the non-employee director compensation program by $5,000 per year. Shareholders also elected all twelve director nominees to one-year terms, approved an advisory resolution on executive compensation, and ratified Ernst & Young LLP as the independent registered public accounting firm for 2025. The Plan amendment received 36,901,484 votes for and 3,277,695 votes against, with 27,534 abstentions and 1,296,357 broker non-votes. The advisory say-on-pay vote received 38,413,776 votes for and 1,763,712 against. Each director nominee received more votes for than against, though vote margins varied; for example, Christopher Causey received 34,893,687 votes for and 5,296,661 against. The filing is largely administrative. Its investor-relevant content is the expanded equity award capacity under the Plan, the extended plan term, and the shareholder vote results. Full details of the Plan are in Exhibit 10.1, and additional information is in the Company's April 29, 2025 proxy statement.

Jun 27, 2025
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Apr 30, 2025)

United Therapeutics Corporation furnished an 8-K on April 30, 2025 under Item 2.02 (Results of Operations and Financial Condition) attaching a press release (Exhibit 99.1) reporting financial results for the quarter ended March 31, 2025. The company reported total revenues of $794.4 million, up 17 percent from $677.7 million in the first quarter of 2024. Net income was $322.2 million, up 5 percent from $306.6 million, and diluted earnings per share were $6.63, up 7 percent from $6.17. Growth was led by Tyvaso products, with total Tyvaso revenues rising 25 percent to $466.3 million, driven by Tyvaso DPI, which rose 33 percent to $302.5 million. Orenitram grew 14 percent to $120.7 million and Remodulin grew 8 percent to $138.2 million. Operating expenses increased, with research and development expense rising 43 percent to $149.0 million, primarily due to a $30.0 million increase in milestone payments for drug delivery device technologies and a $6.6 million increase in fair value adjustments to contingent consideration for manufactured organ projects. Selling, general, and administrative expense rose 18 percent to $170.1 million, and cost of sales rose 27 percent to $92.5 million. Operating income was $382.8 million, compared with $356.3 million a year earlier. Net income growth was held back by a $4.3 million other expense, net, which the company attributed primarily to net unrealized losses on equity securities, and by higher income tax expense of $101.3 million. As of March 31, 2025, the company reported cash, cash equivalents, and marketable investments of $5,032.0 million, total assets of $7,743.9 million, total liabilities of $936.7 million, and stockholders' equity of $6,807.2 million. The press release also previewed the TETON 2 readout in idiopathic pulmonary fibrosis later in 2025, the planned start of a UKidney first-in-human study, and anticipated IND filings for UHeart and UThymoKidney.

Apr 30, 2025
8-K
Material AgreementsFinancial EventsExhibits & Filings

United Therapeutics 8-K Report, Material Agreement (Apr 28, 2025)

United Therapeutics Corporation entered into a new Credit Agreement dated April 25, 2025 with a syndicate of lenders and Wells Fargo Bank, National Association, as administrative agent and swingline lender. The facility is an unsecured revolving credit facility of up to $2.5 billion, which may be increased by up to $750 million in the aggregate subject to lender commitments and other conditions. It matures five years after closing, with lenders able to extend their commitments by one year on request, up to two such extensions. At closing, the company borrowed $200.0 million under the new facility and used the proceeds to repay all outstanding obligations under its 2022 Credit Agreement, dated March 31, 2022, with Wells Fargo. The filing states there were no penalties for the early termination of the 2022 Credit Agreement. Loans bear interest at either an adjusted Term SOFR rate or a fluctuating base rate, plus an applicable margin set quarterly based on the consolidated total leverage ratio. Proceeds may be used to refinance existing indebtedness and for working capital and general corporate purposes. The Credit Agreement includes customary covenants and events of default, including a change of control. Financial maintenance covenants require a consolidated ratio of total indebtedness to EBITDA not greater than 3.50 to 1.00 at each fiscal quarter end (temporarily increasable to 4.00 to 1.00 after qualifying acquisitions or inbound licensing transactions), and a consolidated interest coverage ratio of at least 3.00 to 1.00. As of April 25, 2025, no subsidiaries were required to guarantee the obligations, though subsidiaries may be required to do so in the future.

Apr 28, 2025
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Feb 26, 2025)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported record full-year 2024 total revenues of $2.88 billion, up 24% from 2023, and its third consecutive year of record revenue. Fourth-quarter 2024 total revenues were $735.9 million versus $614.7 million a year earlier. Net income for the full year was $1.20 billion ($24.64 per diluted share), compared with $984.8 million ($19.81 per diluted share) in 2023. Total Tyvaso revenues grew 31% for the year to $1.62 billion, led by Tyvaso DPI, which rose 41% to $1.03 billion. Expenses rose sharply during the year. Selling, general, and administrative expense increased 49% to $709.7 million, including a $71.1 million litigation accrual related to Sandoz Inc. litigation and share-based compensation of $109.5 million. Research and development expense rose 18% to $481.0 million, reflecting manufactured organ projects, licensing payments, and TETON study costs. Cash, cash equivalents, and marketable investments were $4.74 billion at December 31, 2024, down from $4.90 billion a year earlier, while total stockholders' equity rose to $6.44 billion. The company also repurchased 3,547,374 shares under a $1.0 billion accelerated share repurchase agreement in 2024. Management highlighted upcoming catalysts: both TETON studies in idiopathic pulmonary fibrosis are enrolled with data expected starting in the second half of 2025, ralinepag data are expected in 2026, and FDA clearance was announced to begin a potentially registration-enabling xenotransplantation study with UKidney. The filing furnishes the earnings press release as Exhibit 99.1 under Item 2.02 and is not deemed filed for Section 18 purposes.

Feb 26, 2025
8-K
Regulation FDExhibits & Filings

United Therapeutics 8-K Report, Regulation FD Disclosure (Jan 13, 2025)

United Therapeutics Corporation furnished an investor presentation under Item 7.01 (Regulation FD) for its appearance at the 43rd annual J.P. Morgan Healthcare Conference on January 13, 2025, from 2:15 p.m. to 2:55 p.m. Pacific Standard Time. The session was available by live webcast on the company's website, with an archived recording available about 24 hours after the session ends for 30 days. The information is furnished, not filed, under Section 18 of the Exchange Act. The filing's Exhibit 99.1 is the investor presentation dated January 13, 2025. The presentation frames the company's growth in three waves: a foundation of a cash-generating commercial rare disease business, an innovation phase with a cascade of clinical and regulatory events over the next three years, and a longer revolution aimed at addressing the shortage of organs for transplant. It cites nine consecutive quarters of double-digit year-over-year quarterly revenue growth, three years of double-digit annual revenue growth, a 23% revenue compound annual growth rate since Remodulin approval in 2002, and more than $1 billion in annual operating cash flow for the trailing twelve months ending September 30, 2024. The company states it returned $1 billion to shareholders in 2024. The presentation lists expected 2025 events including UKidney IND clearance, TETON 2 data in idiopathic pulmonary fibrosis (IPF), and the ADVANCE OUTCOMES study close in pulmonary arterial hypertension (PAH). It also cites a UKidney transplant completed at NYU on November 25, 2024, and notes all timing reflects current expectations that are subject to change.

Jan 13, 2025
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Oct 30, 2024)

United Therapeutics Corporation, a public benefit corporation (Nasdaq: UTHR), reported financial results for the third quarter ended September 30, 2024, in a press release furnished as Exhibit 99.1 under Item 2.02. Total revenues rose 23 percent year-over-year to $748.9 million from $609.4 million, and the company said this marked a $3 billion annual revenue run rate and a sixth straight quarter of record revenue. Net income increased 16 percent to $309.1 million, with diluted earnings per share of $6.39 versus $5.38 a year earlier. Tyvaso products were the main growth driver, with total Tyvaso revenues up 33 percent to $433.8 million, led by Tyvaso DPI at $274.6 million. Results were also affected by a $65.1 million litigation accrual related to ongoing litigation with Sandoz Inc., recorded in selling, general, and administrative expense, which pushed total SG&A up 72 percent to $219.2 million. The company stated it does not currently expect losses in excess of the accrual to be material, though the final judgment, post-judgment interest, and appeals could change the amount payable. Share-based compensation expense rose 98 percent to $41.7 million, and the effective tax rate fell to 20 percent from 24 percent. Management highlighted upcoming clinical data readouts for the TETON studies in idiopathic pulmonary fibrosis and ADVANCE OUTCOMES in pulmonary arterial hypertension, along with the miroliverELAP phase 1 study and an expected investigational new drug application for UKidney. At September 30, 2024, the company reported cash, cash equivalents, and marketable investments of $4,605.9 million, total assets of $7,123.1 million, total liabilities of $1,022.2 million, and stockholders' equity of $6,100.9 million. The company also disclosed completion of an accelerated share repurchase agreement with Citibank, under which it repurchased 3,547,374 shares in total for an upfront payment of $1.0 billion.

Oct 30, 2024
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Jul 31, 2024)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported second quarter 2024 financial results in a press release dated July 31, 2024 (Exhibit 99.1). Total revenues grew 20 percent year-over-year to $714.9 million, compared with $596.5 million in the second quarter of 2023, and management described it as the fifth straight quarter of record revenue. Net income rose 7 percent to $278.1 million, while diluted net income per share increased 12 percent to $5.85. Growth was led by Tyvaso, whose total net product sales rose 25 percent to $398.2 million, with Tyvaso DPI up 33 percent to $258.3 million and nebulized Tyvaso up 12 percent to $139.9 million. Remodulin, Orenitram, and Unituxin also grew, while Adcirca declined 24 percent. Expenses rose faster than revenue in several areas. Total research and development expense increased 57 percent to $139.6 million, driven by upfront licensing payments for drug delivery devices and organ manufacturing projects, and total selling, general, and administrative expense increased 37 percent to $177.6 million, largely due to share-based compensation tied to a 39 percent rise in the stock price and higher litigation-related legal expenses. Income tax expense was $77.2 million, with an effective tax rate of 22 percent versus 23 percent a year earlier. Cash, cash equivalents, and marketable investments totaled $4,301.9 million at June 30, 2024. The company also disclosed capital returns through an accelerated share repurchase agreement with Citibank entered in March 2024, under which it paid $1.0 billion upfront and received 3,275,199 shares initially. The $300 million tranche settled in June 2024 with an additional 181,772 shares received, and final settlement of the $700 million second tranche is expected in the third quarter of 2024. Management stated it expects data from its clinical pipeline next year.

Jul 31, 2024
8-K
Leadership ChangesShareholder MattersRegulation FD+1

United Therapeutics 8-K Report, Executive Changes (Jun 27, 2024)

United Therapeutics Corporation (Nasdaq: UTHR) reported on its June 27, 2024 Form 8-K that shareholders approved, at the 2024 Annual Meeting held June 26, 2024, an amendment and restatement of its Amended and Restated 2015 Stock Incentive Plan. The 2024 Restatement increases the maximum number of shares issuable under the Plan by 1,320,000 shares, extends the Plan's expiration date to April 25, 2034, revises minimum vesting provisions to permit certain exceptions, and revises the limit on non-employee director compensation to address certain special assignments. The plan amendment was approved by shareholders with 32,982,705 votes for and 4,663,248 votes against. At the same meeting, shareholders elected all eleven director nominees to one-year terms, approved an advisory resolution on executive compensation (35,662,995 for, 1,974,530 against), and ratified Ernst & Young LLP as the independent registered public accounting firm for 2024 (37,189,791 for, 1,373,453 against). Shareholders also elected Jan Malcolm, former Minnesota Commissioner of Health, to the Board, filling the seat vacated by Professor Katherine Klein, who did not stand for re-election. The company announced Malcolm's election in a press release furnished as Exhibit 99.1. The filing is largely governance-related, with the most investor-relevant items being the expanded equity incentive pool and the extended plan term, alongside a board refresh the company describes as focused on new skill sets for its public benefit purpose and organ manufacturing programs.

Jun 27, 2024
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (May 1, 2024)

United Therapeutics Corporation furnished this Form 8-K under Item 2.02 (Results of Operations and Financial Condition) to report its financial results for the quarter ended March 31, 2024, via a press release attached as Exhibit 99.1. Total revenues grew 34 percent year-over-year to $677.7 million, compared with $506.9 million in the first quarter of 2023. Net income rose 27 percent to $306.6 million, and diluted net income per share was $6.17, compared with $4.86. Management described the quarter as another record for revenue with double-digit growth. Growth was led by Tyvaso, whose total revenues increased 56 percent to $372.5 million. Tyvaso DPI revenues rose 92 percent to $227.5 million, driven mainly by higher quantities sold following its June 2022 launch. Nebulized Tyvaso grew 21 percent, benefiting from the absence of distributor destocking that affected the prior-year quarter. Orenitram, Remodulin, and Unituxin also grew, while Adcirca declined 12 percent. Operating expenses increased, with selling, general, and administrative expense up 65 percent to $144.4 million, largely due to share-based compensation tied to the stock price and higher legal expenses. Research and development expense rose 26 percent to $104.1 million. In March 2024 the company entered into a $1.0 billion accelerated share repurchase agreement with Citibank, N.A., receiving an initial delivery of 3,275,199 shares on March 27, 2024. The final settlement is expected in the second quarter of 2024 for $300 million and in the third quarter of 2024 for $700 million. At March 31, 2024, cash, cash equivalents, and marketable investments totaled $4.2 billion, and stockholders' equity was $5.34 billion.

May 1, 2024
8-K
Material AgreementsFinancial Events

United Therapeutics 8-K Report, Material Agreement (Mar 29, 2024)

United Therapeutics Corporation filed this Current Report on Form 8-K dated March 29, 2024 to disclose an extension of its Credit Agreement, originally entered into on March 31, 2022 with certain subsidiary guarantors, the lenders named therein, and Wells Fargo Bank, National Association, as administrative agent and swingline lender. The Credit Agreement provides an unsecured revolving credit facility of up to $1.2 billion and a second unsecured revolving credit facility of up to $800 million, which may be increased by up to $500 million in the aggregate subject to lender commitments and other conditions. The filing states that the Company exercised its first one-year extension option on March 31, 2023, and that, under Section 2.7 of the Credit Agreement, the maturity of each lender's commitments and loans has now been extended by one additional year to March 31, 2029, effective March 29, 2024. The filing notes that the lenders' extension right is limited to a maximum of two such one-year extensions. The filing is brief and is limited to this maturity extension under Items 1.01 and 2.03, which incorporate the extension information by reference. Full terms of the Credit Agreement are in the exhibit to the Company's April 1, 2022 Form 8-K, which the filing incorporates by reference.

Mar 29, 2024
8-K
Material AgreementsRegulation FDExhibits & Filings

United Therapeutics 8-K Report, Material Agreement (Mar 25, 2024)

United Therapeutics Corporation (Nasdaq: UTHR) announced on March 25, 2024 that its Board of Directors approved a share repurchase program authorizing the purchase of up to $1 billion of its common stock. The same day, the company entered into an accelerated share repurchase (ASR) agreement with Citibank, N.A. (Citi) to repurchase approximately $1 billion of stock under that program. Under the ASR agreement, the company makes an aggregate upfront payment of $1.0 billion to Citi and receives an initial delivery of approximately 3,275,199 shares on March 27, 2024, representing approximately 80% of the total shares that would be repurchased, based on the March 25, 2024 closing price. The final number of shares depends on the average daily volume-weighted average price over the repurchase period, less a discount, and the company may receive additional shares or, in limited circumstances, make a cash payment or deliver shares to Citi at final settlement. Final settlement is expected in the second quarter of 2024 for $300 million of the transactions and in the third quarter of 2024 for $700 million. The press release states that the repurchase builds on the company's planned $400 million paydown of its revolving credit facility in 2024, of which $100 million was paid down in the first quarter of 2024. Chairperson and CEO Martine Rothblatt said the company is confident in its ability to fund future facilities while balancing capital allocation, and described the current valuation of the stock as making repurchases a solid investment. The press release notes approximately 47.1 million shares outstanding as of February 14, 2024.

Mar 25, 2024
8-K
Other Events

United Therapeutics 8-K Report, Corporate Update (Feb 27, 2024)

On February 26, 2024, United Therapeutics Corporation filed a motion in the U.S. District Court for the District of Delaware seeking a preliminary injunction in its patent litigation with Liquidia Technologies, Inc. The Company alleges that Liquidia's product for pulmonary hypertension associated with interstitial lung disease (PH-ILD) infringes its U.S. Patent No. 11,826,327 (the '327 patent), which expires in 2042. The Company asked the court to enjoin Liquidia from marketing its product for PH-ILD until the infringement claims are adjudicated. Liquidia's investigational product is currently tentatively approved by the FDA for pulmonary arterial hypertension (PAH) but not PH-ILD. Separately, the Company has sued the FDA in the U.S. District Court for the District of Columbia over the agency's review of Liquidia's amendment to its pending new drug application (NDA) seeking a PH-ILD indication. The Company argues that FDA rules require a new indication to be pursued in a new NDA, and it believes that if Liquidia must file a new NDA, the Company would be entitled to a 30-month stay of any PH-ILD approval based on the '327 patent litigation. The filing states that if either a preliminary injunction or a 30-month stay is granted, Liquidia's product would be precluded from marketing for PH-ILD while the patent litigation proceeds. The filing notes that Liquidia's NDA relies on clinical data underlying the Company's Tyvaso (treprostinil) Inhalation Solution, which is FDA-approved for both PAH and PH-ILD, with the PH-ILD indication added to the nebulized Tyvaso label in 2021. Further litigation details are referenced in Note 14 to the Company's Annual Report on Form 10-K filed on February 21, 2024.

Feb 27, 2024
8-K
Earnings & ResultsRegulation FDExhibits & Filings

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

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported record full-year 2023 total revenues of $2.33 billion (2023: $2,327.5 million vs. 2022: $1,936.3 million), up 20%. Net income for the year was $984.8 million, 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 million 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 million 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.

Feb 21, 2024
8-K
Other Events

United Therapeutics 8-K Report, Corporate Update (Dec 20, 2023)

United Therapeutics Corporation disclosed in this Form 8-K, filed December 20, 2023, that the U.S. Court of Appeals for the Federal Circuit issued a decision that day affirming an inter partes review decision by the Patent Trials and Appeals Board that the claims of U.S. Patent No. 10,716,793 (the '793 patent) should be canceled as invalid. Liquidia Technologies, Inc. initiated the IPR. The '793 patent is listed in the FDA Orange Book for Tyvaso and Tyvaso DPI, both marketed by the Company. The filing states that the Federal Circuit had earlier affirmed a District of Delaware decision that Liquidia's proposed Yutrepia product infringes the '793 patent and that Liquidia had not proved invalidity, which currently bars Liquidia from obtaining final FDA approval until the patent expires. The December 20 decision would allow Liquidia to launch Yutrepia before expiration unless it is reversed. United Therapeutics may seek rehearing and/or Supreme Court review and is evaluating its options. The filing also states that the claims are not canceled until all appeals are exhausted. The filing further describes a September 2023 lawsuit by United Therapeutics against Liquidia asserting that Liquidia's amended NDA for Yutrepia, which now includes pulmonary hypertension associated with interstitial lung disease (PH-ILD), infringes the '793 patent. In November 2023 the Company added U.S. Patent No. 11,826,327, which expires in January 2042 and covers use of inhaled treprostinil at specific dosages to improve exercise capacity in PH-ILD patients. The FDA set a PDUFA goal date of January 24, 2024 for review of Liquidia's NDA.

Dec 20, 2023
8-K
Other Events

United Therapeutics 8-K Report, Corporate Update (Nov 29, 2023)

United Therapeutics Corporation filed this Current Report on Form 8-K on November 29, 2023, under Item 8.01 (Other Events). As of November 27, 2023, the company entered into an amendment extending the term of its exclusive license agreement with Eli Lilly and Company covering the U.S. marketing, promotion, and sale of Adcirca (tadalafil) tablets through December 31, 2026. Under the agreement, Lilly granted United Therapeutics an exclusive license to develop, market, promote, and commercialize Adcirca for the treatment of pulmonary hypertension in the United States. The license was previously set to expire on December 31, 2023, so the amendment extends the arrangement by three years. The filing states that all other terms of the license agreement remain the same. The filing does not disclose financial figures related to the amendment.

Nov 29, 2023
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Nov 1, 2023)

United Therapeutics Corporation reported third quarter 2023 financial results in a press release furnished as Exhibit 99.1 to this Current Report on Form 8-K, dated November 1, 2023. Total revenues grew 18% year-over-year to $609.4 million, compared with $516.0 million in the third quarter of 2022. Net income rose 12% to $267.6 million, and diluted net income per share increased 10% to $5.38 from $4.91. Management described the results as record quarterly revenue with double-digit revenue growth. Growth was driven largely by Tyvaso DPI, with net product sales of $205.1 million versus $63.1 million a year earlier, following its commercial launch in June 2022. Total Tyvaso revenues rose 26% to $325.8 million, while nebulized Tyvaso sales fell 38% to $120.7 million as patients shifted to Tyvaso DPI. Remodulin sales increased 15% to $131.1 million and Orenitram rose 5% to $92.0 million. Research and development expense increased 28% to $84.7 million, reflecting the TETON 1 and TETON 2 studies of nebulized Tyvaso in idiopathic pulmonary fibrosis, and selling, general and administrative expense rose 30% to $127.6 million, largely due to share-based compensation tied to stock price movement. As of September 30, 2023, the company reported cash, cash equivalents and marketable investments of $4,936.3 million, total assets of $7,023.6 million, and total liabilities of $1,311.5 million. Management said the TETON 1, TETON 2 and ADVANCE OUTCOMES studies could generate data in 2025 and reiterated an expected $4 billion annual revenue run rate by mid-decade.

Nov 1, 2023
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Aug 2, 2023)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported financial results for the quarter ended June 30, 2023 in a press release furnished as Exhibit 99.1 to this Form 8-K dated August 2, 2023. Total revenues grew 28% year-over-year to $596.5 million, compared with $466.9 million in the second quarter of 2022. Net income was $259.2 million, up 123% from $116.0 million, and diluted net income per share was $5.24 versus $2.41 a year earlier. Net product sales of the treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $129.2 million, or 31%, with Tyvaso revenue rising to $318.9 million from $201.0 million, driven by patient growth following the June 2022 commercial launch of Tyvaso DPI. Total operating expenses were $283.1 million and operating income was $313.4 million, compared with $265.1 million and $201.8 million, respectively, in the prior-year quarter. Cost of sales rose sharply, to $64.1 million from $29.7 million, reflecting Tyvaso DPI royalty expense and product costs. Share-based compensation fell to $13.8 million from $65.5 million, mainly because of a smaller share tracking awards plan benefit tied to a one percent decrease in the stock price during the quarter. Cash, cash equivalents, and marketable investments were $4,702.6 million at June 30, 2023, against total assets of $6,681.3 million and stockholders' equity of $5,411.0 million. Management stated that it expects to reach a $4 billion annual revenue run rate by mid-decade, and cited potential future revenue growth from Tyvaso in pulmonary fibrosis and ralinepag in pulmonary arterial hypertension. The filing also notes that the press release is furnished under Item 2.02 and is not deemed filed for purposes of Section 18 of the Exchange Act.

Aug 2, 2023
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Jul 24, 2023)

United Therapeutics Corporation filed this Current Report on Form 8-K on July 24, 2023 under Item 8.01 (Other Events) to disclose a press release providing an update on its pending patent litigation with Liquidia Technologies, Inc. The press release, attached as Exhibit 99.1, reports that the U.S. Court of Appeals for the Federal Circuit affirmed the district court's decision in the patent litigation United Therapeutics brought against Liquidia. The Federal Circuit affirmed that Liquidia's proposed Yutrepia product infringes U.S. Patent No. 10,716,793 (the '793 patent), which relates to a method of administering treprostinil via inhalation. As a result, the FDA cannot grant Liquidia final approval for Yutrepia until the '793 patent expires on May 14, 2027, except in certain circumstances. The Federal Circuit also affirmed that certain claims of U.S. Patent No. 9,593,066 (the '066 patent), which relates to a method of making treprostinil, are either invalid or not infringed by Liquidia. Both parties may request rehearing with respect to the adverse portions of the affirmance. The filing also notes that the Patent Trial and Appeal Board had issued a final written decision in an inter partes review finding all claims of the '793 patent unpatentable, and United Therapeutics has appealed that decision, with the appeal pending. The company expects that the PTAB decision will not affect the district court's order barring FDA final approval unless all claims Liquidia was found to infringe are invalidated after all appeals are exhausted.

Jul 24, 2023
8-K/A
Shareholder Matters

United Therapeutics 8-K/A Report, Shareholder Vote Results (Jul 14, 2023)

United Therapeutics Corporation filed this Current Report on Form 8-K/A on July 14, 2023 to amend its Original Form 8-K filed June 28, 2023, which reported results of the Company's 2023 Annual Meeting of Shareholders held June 26, 2023. The sole purpose of this amendment is to disclose the Company's decision on the frequency of future shareholder advisory "say on pay" votes on executive compensation, as required by Item 5.07(d) of Form 8-K. No other changes were made to the Original Form 8-K. A majority of votes cast at the 2023 Annual Meeting favored conducting say-on-pay votes annually, consistent with the Board of Directors' recommendation in the Company's proxy statement for that meeting. In accordance with that result and the Board's recommendation, the Board determined that the Company will hold say-on-pay votes on an annual basis until the next required shareholder advisory vote on frequency. The next advisory vote on say-on-pay frequency is currently expected at the Company's 2029 Annual Meeting of Shareholders. The filing is signed by Paul A. Mahon, General Counsel.

Jul 14, 2023
8-K
Leadership ChangesShareholder MattersExhibits & Filings

United Therapeutics 8-K Report, Executive Changes (Jun 28, 2023)

On June 26, 2023, United Therapeutics Corporation's shareholders approved an amendment and restatement (the "2023 Restatement") of the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan, effective June 26, 2023. The Board had previously approved the restatement on the recommendation of its Compensation Committee. The restatement increases the maximum number of common shares issuable under the Plan by 1,000,000 and extends the Plan's expiration date to April 20, 2033. The Plan permits stock options, stock appreciation rights, restricted stock, restricted stock units, stock awards (any of which may be performance-based), and incentive bonuses. At the same June 26, 2023 Annual Meeting, shareholders voted on five matters. All twelve director nominees were elected to one-year terms, with each nominee receiving more votes for than against. Shareholders approved the advisory resolution on executive compensation, with 38,688,651 votes for and 1,188,503 against. For the advisory vote on the frequency of future say-on-pay votes, the largest number of votes (39,071,056) favored one year. Shareholders also approved the Plan amendment (34,925,060 for, 5,085,389 against) and ratified Ernst & Young LLP as the independent registered public accounting firm for 2023 (40,725,112 for, 748,871 against). For investors, the filing is primarily a governance and equity-compensation update. The expanded share reserve and extended term give the company more capacity for equity awards to directors, officers, and employees, which may be relevant to dilution considerations. The filing does not state a dollar value or share count outstanding beyond the amounts shown in the voting results.

Jun 28, 2023
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (May 3, 2023)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported financial results for the quarter ended March 31, 2023 in Exhibit 99.1, a press release dated May 3, 2023. Total revenues were $506.9 million, up 10% from $461.9 million in the first quarter of 2022. Net income was $240.9 million, essentially flat versus $239.9 million a year earlier, while diluted net income per share fell to $4.86 from $5.03, a 3% decline as stated in the filing. Growth was led by Tyvaso, whose net product sales rose to $238.4 million from $172.0 million, a 39% increase that management attributed primarily to higher quantities sold following the June 2022 launch of Tyvaso DPI and continued patient growth after the March 2021 label expansion. Orenitram sales rose 7% to $88.2 million, while Remodulin declined 8% to $121.4 million and Unituxin declined 12% to $49.1 million. Cost of sales increased 102% on a total basis, primarily due to Tyvaso DPI royalty expense and product costs, and research and development expense rose 20% to $82.9 million, driven mainly by the TETON studies of Tyvaso in idiopathic pulmonary fibrosis. At March 31, 2023, the company reported cash, cash equivalents, and marketable investments of $4,629.0 million, total assets of $6,346.0 million, total liabilities of $1,222.8 million, and stockholders' equity of $5,123.2 million. Management highlighted 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 a clinical study of the CLES ex vivo lung perfusion technology. The effective tax rate was 17% versus 22% a year earlier.

May 3, 2023
8-K
Corporate ChangesExhibits & Filings

United Therapeutics 8-K Report, Bylaw Amendment (Apr 21, 2023)

United Therapeutics Corporation filed this Current Report on Form 8-K to disclose the adoption of its Tenth Amended and Restated Bylaws. The Board of Directors approved and adopted the Bylaws on April 20, 2023, and they became effective the same day. The filing is limited to governance changes; it does not report financial results, transactions, or operating developments. The amendments focus mainly on stockholder rights and meeting procedures. They tighten requirements for stockholder business proposals and director nominations, including added background disclosure, solicitation representations, and a requirement that nominating stockholders intend to deliver a proxy statement to holders of at least 67% of the voting power entitled to vote in director elections. The bylaws also require a non-white proxy card color for stockholders soliciting proxies, eliminate the stockholder list inspection requirement at meetings, and opt out of Section 116 of the Delaware General Corporation Law. Other changes address adjourned meetings, inspectors of election, proxy expiration and revocability, officer delegations, emergency bylaws under Section 110 of the DGCL, and Board reliance on company records. The bylaws also state conspicuously on share certificates and issuance notices that the company is a public benefit corporation. The full text of the bylaws is filed as Exhibit 3.1.

Apr 21, 2023
8-K
Material AgreementsFinancial Events

United Therapeutics 8-K Report, Material Agreement (Mar 31, 2023)

United Therapeutics Corporation filed this Current Report on Form 8-K dated March 31, 2023, to report two related items under its existing Credit Agreement. The Credit Agreement, originally entered into on March 31, 2022, with certain subsidiaries as guarantors, the lenders named therein, and Wells Fargo Bank, National Association, as administrative agent and swingline lender, provides for an unsecured revolving credit facility of up to $1.2 billion and a second unsecured revolving credit facility of up to $800 million. The facilities may be increased by up to $500 million in the aggregate, subject to lender commitments and other conditions. Under Section 2.7 of the Credit Agreement, the maturity of each lender's commitments and loans has been extended by one year to March 31, 2028, effective as of March 31, 2023. The filing describes the extension as a one-year maturity extension following the Company's request, with the facilities otherwise maturing five years after closing, and with up to two such extensions permitted in total. The filing is informational in nature and does not state any change to the facility sizes, pricing, or other terms beyond the maturity date. The Company's General Counsel, Paul A. Mahon, signed the report.

Mar 31, 2023
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Feb 22, 2023)

United Therapeutics Corporation reported record full-year 2022 total revenues of $1.94 billion ($1,936.3 million), up from $1,685.5 million in 2021, as U.S. patients treated with its treprostinil-based therapies reached an all-time high in the fourth quarter of 2022. Fourth-quarter 2022 total revenues were $491.5 million, compared with $415.2 million a year earlier. Net income for the full year was $727.3 million, or $15.00 per diluted share, compared with $475.8 million, or $10.06 per diluted share, in 2021. Fourth-quarter net income was $132.1 million, or $2.67 per diluted share. Growth was driven primarily by Tyvaso, whose net product sales rose to $873.0 million in 2022 from $607.5 million in 2021, reflecting the June 2022 commercial launch of Tyvaso DPI and continued patient growth following the March 2021 PH-ILD label expansion. Net product sales of the treprostinil-based products (Tyvaso, Remodulin and Orenitram) grew $271.0 million, or 19%, for the year. Unituxin and Adcirca sales declined. Operating expenses for the year fell to $956.6 million from $1,129.6 million, largely because 2021 included a $130.0 million impairment in research and development expense and a $105.0 million pediatric disease priority review voucher purchase. Cost of sales rose as royalty expense and Tyvaso DPI product costs increased. The company stated its long-term goal of doubling revenue to a $4 billion run rate by the end of 2025 and noted pivotal clinical data expected for Tyvaso in idiopathic pulmonary fibrosis and ralinepag in pulmonary arterial hypertension. Cash, cash equivalents and marketable investments were $4,154.9 million at December 31, 2022, up from $3,580.6 million, and stockholders' equity was $4,796.7 million.

Feb 22, 2023
8-K
Regulation FDExhibits & Filings

United Therapeutics 8-K Report, Regulation FD Disclosure (Jan 9, 2023)

United Therapeutics Corporation furnished an investor presentation under Item 7.01 (Regulation FD Disclosure) in connection with its overview and update at the 41st annual J.P. Morgan Healthcare Conference in San Francisco on January 9, 2023. The presentation ran from 1:30 p.m. to 2:10 p.m. Pacific Standard Time, was available via live webcast, and slides were posted to the company's website. The information is furnished rather than filed under Section 18 of the Exchange Act. The presentation, furnished as Exhibit 99.1, centers on two areas: pulmonary hypertension (PH) and pulmonary fibrosis. For PH, the company says it expects rapid annual growth from three drivers and highlights Tyvaso DPI as differentiated, with the company stating it reached approximately 6,000 Tyvaso and Tyvaso DPI patients in the fourth quarter of 2022, meeting a doubling goal set in 2021 that contemplated roughly 3,000 patients at the time of PH-ILD approval in late March 2021. For pulmonary fibrosis, the company describes an opportunity to more than double current revenue and cites the TETON studies evaluating Tyvaso for idiopathic pulmonary fibrosis (IPF), noting that Tyvaso is not approved to treat IPF. The presentation also describes the company's financial position, stating it had more than $4 billion in cash and short- and long-term investments as of September 30, 2022, that cash operating expenses are planned to be less than 50% of prior-year revenue, and that it maintains a two-year inventory of Remodulin, Tyvaso, and Orenitram finished drug product. The company also describes its pipeline as including five registration phase studies and seven preclinical product leads.

Jan 9, 2023
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Nov 2, 2022)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, furnished this Form 8-K on November 2, 2022 to report its results for the quarter ended September 30, 2022, attaching a press release as Exhibit 99.1. Total revenues rose 16% year-over-year to $516.0 million from $444.7 million, and net income increased 47% to $239.3 million. Diluted earnings per share were $4.91, compared with $3.42 a year earlier. Management said this was the company's highest quarterly revenue in its history and noted that Tyvaso became its first $1 billion annual run rate product. Growth was driven primarily by Tyvaso, whose net product sales rose $93.5 million, or 57%, to $257.7 million. The company attributed this mainly to higher quantities sold following the June 2022 launch of Tyvaso DPI and continued patient growth after the March 2021 PH-ILD label expansion. Remodulin sales declined 9% and Unituxin sales declined 17%. Operating income was $314.3 million, and the company reported cash, cash equivalents, and marketable investments of $4,059.4 million at September 30, 2022. The press release also updated the pipeline. The TETON 2 phase 3 study of Tyvaso in idiopathic pulmonary fibrosis enrolled its first patient in October 2022, and the company reported that TETON 1 began enrolling in June 2021. The company discontinued the PERFECT study of Tyvaso in PH-COPD in September 2022 following a recommendation from its independent Data Safety Monitoring Committee.

Nov 2, 2022
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Oct 11, 2022)

On October 11, 2022, United Therapeutics Corporation filed a Form 8-K under Item 8.01 (Other Events) to report that it issued a press release announcing enrollment of the first patient in the phase 3 TETON 2 clinical study of Tyvaso (treprostinil) Inhalation Solution in patients with idiopathic pulmonary fibrosis (IPF). The filing is a notice; the substance is contained in the attached press release (Exhibit 99.1). According to the press release, TETON 2 is a 396-patient, multicenter, randomized, double-blind, placebo-controlled phase 3 registration study conducted at sites outside the United States and Canada. Patients are randomized 1:1 to Tyvaso or placebo, starting at three breaths four times daily and titrating to a target of 12 breaths four times daily. The 52-week study's primary endpoint is the change in forced vital capacity (FVC) from baseline to week 52. Secondary endpoints include time to clinical worsening, time to first acute exacerbation of IPF, overall survival at week 52, change in percent predicted FVC, and change in the King's Brief Interstitial Lung Disease questionnaire. The company describes TETON 2 as the second registration study in the broader global TETON program; TETON 1 is being conducted at sites in the United States and Canada. The press release states that Tyvaso is approved by the FDA for pulmonary arterial hypertension and for pulmonary hypertension associated with interstitial lung disease (PH-ILD), with the PH-ILD indication added in March 2021. Tyvaso is not approved in any jurisdiction for IPF patients without documented PH, and Tyvaso DPI is not being evaluated in the TETON program.

Oct 11, 2022
8-K
Other Events

United Therapeutics 8-K Report, Corporate Update (Sep 20, 2022)

On September 20, 2022, United Therapeutics Corporation announced the termination of the PERFECT clinical study evaluating Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease. The Company stated that it terminated the study based upon a recommendation of the study's independent Data Safety Monitoring Committee (DSMC), following a routine safety and efficacy analysis conducted by the DSMC. The Company stated that it will review the available data from the study and plans to share the results with the scientific community. The filing does not disclose specific study data, results, or financial impact. The disclosure was made under Item 8.01 (Other Events). For investors, the key takeaway is the discontinuation of a Tyvaso clinical program in COPD-associated pulmonary hypertension, with the decision based on the independent DSMC's routine review rather than a company-initiated action. Further details on the findings are expected when the company shares the data.

Sep 20, 2022
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (Sep 1, 2022)

United Therapeutics Corporation filed this Form 8-K to report, under Item 8.01 (Other Events), a press release dated August 31, 2022 updating its pending patent litigation with Liquidia Technologies, Inc. The filing attaches that press release as Exhibit 99.1. According to the press release, the U.S. District Court for the District of Delaware issued an opinion finding that Liquidia would induce infringement of various claims of United Therapeutics' '793 patent by marketing its proposed treprostinil inhalation powder, Yutrepia. The Court also found that Liquidia failed to prove any claim of the '793 patent at issue is invalid. The company expects the Court to enter an injunction barring the FDA from granting final approval for Yutrepia until the '793 patent expires on May 14, 2027. The Court found Yutrepia would infringe several claims of the '066 patent but held those claims invalid. Both parties may appeal, and the company is evaluating next steps. Separately, the Patent Trial and Appeal Board issued a final written decision in an inter partes review initiated by Liquidia holding the '793 patent invalid. United Therapeutics has requested rehearing and, if the PTAB does not reverse, will appeal. The company states the '793 patent remains valid during the pendency of appeals and expects any IPR appeal process to take at least a year, during which the injunction is expected to remain in place.

Sep 1, 2022
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (Aug 3, 2022)

United Therapeutics Corporation filed this Form 8-K under Item 2.02 (Results of Operations and Financial Condition) to furnish a press release, attached as Exhibit 99.1, reporting its earnings for the quarter ended June 30, 2022. Total revenues grew 5% year-over-year to $466.9 million from $446.5 million. However, net income declined 33% to $116.0 million from $172.6 million, and diluted earnings per share fell 34% to $2.41 from $3.65. Management attributed the revenue growth primarily to Tyvaso, which rose 31% to $201.0 million on higher quantities sold following the PH-ILD label expansion, partially offset by declines in Unituxin, Remodulin and Adcirca. The increase in operating expenses, particularly share-based compensation (up 125% to $65.5 million, driven by a 31 percent rise in the stock price), and an other expense, net line of $51.8 million, largely from unrealized losses on equity securities, drove the lower profitability. On the product and pipeline side, the FDA approved Tyvaso DPI in May 2022 for PAH and PH-ILD, with first commercial shipments in June 2022. Management noted a record number of patients on its treprostinil therapies, including about 500 added Tyvaso patients in the quarter, and reiterated a goal of 6,000 Tyvaso patients by year-end. Research and development expense rose 26% to $93.9 million, with the company citing increased preclinical spending on technologies to increase the supply of transplantable organs. Ongoing late-stage programs include TETON 1 and TETON 2 in idiopathic pulmonary fibrosis, the PERFECT study in PH-COPD (expanded from 136 to 314 patients after a design change), and ralinepag phase 3 studies. At June 30, 2022, cash, cash equivalents and marketable investments were $3,897.1 million against total assets of $5,543.3 million.

Aug 3, 2022
8-K
Leadership ChangesShareholder MattersExhibits & Filings

United Therapeutics 8-K Report, Executive Changes (Jun 28, 2022)

At its 2022 Annual Meeting of Shareholders on June 27, 2022, United Therapeutics Corporation's shareholders approved an amendment and restatement of the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the "2022 Restatement"), which the Board had previously approved on the recommendation of its Compensation Committee. The 2022 Restatement is effective June 27, 2022. It increases the maximum number of shares of common stock issuable under the Plan by 500,000 shares and extends the Plan's expiration date to April 25, 2032. The Plan is administered by the independent Compensation Committee and permits stock options, stock appreciation rights, restricted stock, restricted stock units, stock awards, and incentive bonuses, any of which may be performance-based. Shareholders also voted on the election of nine directors to one-year terms, an advisory resolution on executive compensation, and ratification of Ernst & Young LLP as the independent registered public accounting firm for 2022. For the Plan amendment, the filing reports 34,846,811 votes for, 4,818,829 votes against, 42,608 abstentions, and 1,748,363 broker non-votes. For the advisory say-on-pay vote, it reports 38,935,752 votes for and 690,791 votes against. Ernst & Young's ratification received 41,145,964 votes for and 300,817 votes against. The filing is largely procedural. Its investor-relevant content is the expanded equity award capacity under the Plan and the extended term, and the vote tallies show the level of shareholder support for each matter. Full Plan terms are described in the April 29, 2022 proxy statement and in Exhibit 10.1, the full text of the Plan.

Jun 28, 2022
8-K
Other EventsExhibits & Filings

United Therapeutics 8-K Report, Corporate Update (May 24, 2022)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported in this Form 8-K filed May 24, 2022 that the U.S. Food and Drug Administration approved its new drug application for Tyvaso DPI (treprostinil) inhalation powder on May 23, 2022. The company announced the approval in a press release dated May 24, 2022, attached as Exhibit 99.1. The approval covers treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The press release describes Tyvaso DPI as a new formulation and inhalation device for inhaled treprostinil and as the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD. The press release states that commercial launch activities are underway and that patient availability is expected in June 2022. Approval was supported by the open-label BREEZE study of 51 PAH patients transitioned from Tyvaso Inhalation Solution to Tyvaso DPI, in which the company reports safety and tolerability over a three-week treatment phase, with significant improvements in six-minute walk distance, device preference and satisfaction, and patient-reported outcomes. The company also states that Tyvaso Inhalation Solution and Tyvaso DPI are the only therapies FDA-approved to treat PH-ILD. The filing itself contains no financial results, sales projections or guidance. Investors would therefore need to look to later company disclosures for the commercial impact of the launch. The safety section highlights standard warnings for the class, including symptomatic hypotension, increased bleeding risk, bronchospasm, and interactions with CYP2C8 modulators.

May 24, 2022
8-K
Earnings & ResultsExhibits & Filings

United Therapeutics 8-K Report, Financial Results (May 4, 2022)

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported first quarter 2022 results in Exhibit 99.1, a press release dated May 4, 2022. Total revenues were $461.9 million, up 22% from $379.1 million in the first quarter of 2021. Net income was $239.9 million, or $5.03 per diluted share, compared with $28.3 million, or $0.61 per diluted share, a year earlier. The prior-year quarter included a $107.3 million in-process R&D impairment and a $105.0 million priority review voucher purchase, which lowered R&D expense in the 2022 period, and a $91.9 million gain on the sale of an investment. Tyvaso revenue rose to $172.0 million from $123.0 million, reflecting the PH-ILD label expansion, and Unituxin grew with the Japan launch in September 2021. Share-based compensation was a benefit of $21.1 million, driven by a 17 percent decline in the stock price during the quarter, which lifted operating income to $288.0 million. Income tax expense was $68.8 million, an effective tax rate of 22 percent. The filing also updates the Tyvaso DPI NDA, which the FDA extended to a review deadline of May 2022 after a major amendment. The company is running phase 3 studies in TETON 1 and TETON 2 for IPF, PERFECT for PH-COPD, and ADVANCE CAPACITY and ADVANCE OUTCOMES for oral ralinepag. Cash, cash equivalents and marketable investments totaled $3,826.8 million at March 31, 2022.

May 4, 2022
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