UTHR SEC Filings

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

United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2026

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.

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.

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.

United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2026

United Therapeutics Corporation reported total revenues of $783.3 million for the three months ended June 30, 2026, down 2% from $798.6 million a year earlier, and $1,564.8 million for the six months, down 2% from $1,593.0 million. Net income rose to $333.0 million for the quarter from $309.5 million, and diluted EPS was $7.27 versus $6.41. Operating income fell to $330.8 million from $364.5 million, and the company's effective tax rate dropped to 12% for the six months from 24%, which the filing attributes mainly to increased excess tax benefits from share-based compensation. Interest income declined to $31.5 million from $51.3 million, reflecting lower marketable investments after the March 2026 accelerated share repurchases. Product mix shifted within the Tyvaso franchise. Tyvaso DPI net product sales increased 4% to $326.6 million in the quarter, while Nebulized Tyvaso fell 18% to $126.0 million, and the filing says competitive therapies negatively affected Nebulized Tyvaso, Tyvaso DPI and Remodulin sales. Cost of sales rose to $99.5 million from $87.6 million, including $19.2 million of inventory reserve expense in the quarter, of which $7.5 million related to estimated losses under a commercial supply agreement for Tyvaso DPI inventory. Capital deployment was heavy during the period. The company paid $1.5 billion under two 2026 accelerated share repurchase agreements, leaving $500 million available under the program through March 9, 2027. Cash and cash equivalents were $1,803.2 million and total cash and marketable investments were $3,803.4 million at June 30, 2026, down from $4,697.0 million at December 31, 2025. Subsequent to quarter end, the company acquired Thymmune Therapeutics for an upfront payment of approximately $140.0 million plus up to $160.0 million in milestone-based earnouts, and Boehringer Ingelheim filed a trade secret and tortious interference lawsuit on July 17, 2026, which the company says it intends to vigorously defend.

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.

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.

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.

United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2026

United Therapeutics Corporation's quarterly report for the period ended March 31, 2026 shows total revenues of $781.5 million, down from $794.4 million in the prior-year quarter. Operating income fell to $325.8 million from $382.8 million, and net income was $274.9 million versus $322.2 million, with diluted EPS of $5.82 compared with $6.63. Cost of sales rose to $133.4 million from $92.5 million, driven mainly by inventory reserve expense, including $26.8 million tied to an estimated loss from a commercial supply agreement for Tyvaso DPI. Other expense, net was $46.3 million, primarily reflecting net unrealized losses on equity securities of $61.6 million. The company repurchased $1.5 billion of common stock under two accelerated share repurchase agreements entered in March 2026, under a $2.0 billion authorization. Total stockholders' equity declined to $5,901.1 million from $7,096.2 million at December 31, 2025, and cash, cash equivalents and marketable investments totaled $3,471.1 million, down from $4,697.0 million. The 2025 Credit Agreement's $2.5 billion revolving facility had a zero outstanding balance at March 31, 2026. Management highlighted positive Phase 3 results: TETON-1 and TETON-2 for Nebulized Tyvaso in IPF, with an sNDA planned by the end of summer 2026, and ADVANCE OUTCOMES for ralinepag, with an NDA also planned by the end of summer 2026. Ongoing litigation includes a Sandoz judgment under appeal and patent and trade secret disputes with Liquidia.

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.

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.

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.

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.

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.

United Therapeutics Annual Report, Year Ended Dec 31, 2025

United Therapeutics Corporation (UTHR) reported total revenues of $3,182.7 million for 2025, up from $2,877.4 million in 2024 and $2,327.5 million in 2023. Net income was $1,334.7 million in 2025, compared with $1,195.1 million in 2024, and diluted earnings per share were $27.86, versus $24.64 in 2024. Growth was driven primarily by Tyvaso DPI, whose net product sales reached $1,292.5 million, and by Orenitram, with $496.9 million in net product sales. Combined Tyvaso DPI and Nebulized Tyvaso net product sales were $1,878.2 million, representing 59 percent of total revenues. Remodulin, Unituxin, and Adcirca are the company's other marketed products. The company ended 2025 with cash and cash equivalents of $1,557.1 million and total marketable investments of $3,140.0 million, for combined cash and investments of $4,697.0 million. It had no outstanding balance on its $2.5 billion unsecured revolving credit facility at year end. Cash from operating activities was $1,561.2 million. The company repurchased $1.0 billion of common stock under 2025 accelerated share repurchase agreements, and it expects to spend approximately $400 million on capital expenditures during 2026 through 2028, mainly on manufacturing and xenotransplantation facilities. Key pipeline events are the TETON 1 Phase 3 readout for Nebulized Tyvaso in IPF, expected late in the first quarter or early in the second quarter of 2026, and the ADVANCE OUTCOMES topline data for ralinepag, expected on a similar timeline. The filing also highlights competitive and legal risks, including the launch of Liquidia's Yutrepia in June 2025, Merck's Winrevair, generic competition for Remodulin, and ongoing litigation with Liquidia and Sandoz, which has an accrued liability of $74.1 million.

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.

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.

United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2025

United Therapeutics Corporation reported third-quarter 2025 total revenues of $799.5 million, up from $748.9 million a year earlier, and nine-month revenues of $2,392.5 million, up from $2,141.5 million. Operating income rose to $388.5 million from $343.1 million, and net income was $338.7 million, compared with $309.1 million. Diluted earnings per share were $7.16, versus $6.39 in the prior-year quarter. Tyvaso DPI was the main driver, with third-quarter net product sales of $336.2 million, up from $274.6 million, while Nebulized Tyvaso declined to $141.8 million from $159.2 million. Net cash provided by operating activities was $1,215.0 million for the nine months, compared with $985.9 million a year earlier. The company's cash and marketable investments totaled $4,334.9 million at September 30, 2025, down from $4,742.3 million at December 31, 2024. The decline reflects a $1.0 billion accelerated share repurchase executed in August 2025, purchases of property, plant, and equipment totaling $347.6 million for the nine months, and a $200.0 million revolving credit borrowing that was fully repaid during the second quarter. The company had no outstanding debt at September 30, 2025 under its $2.5 billion 2025 Credit Agreement. The filing budgets approximately $520 million for capital expenditures from the fourth quarter of 2025 through 2027, mainly for a new Tyvaso DPI manufacturing facility and designated pathogen-free facilities. Key risks in the filing include the Sandoz litigation, for which the company has accrued $73.3 million and an appeal is pending with oral argument scheduled for November 12, 2025. Competition from Liquidia's Yutrepia, launched in June 2025, is ongoing, and several patent and trade secret cases with Liquidia remain unresolved. The company also reported that TETON 2, a phase 3 study of Nebulized Tyvaso in idiopathic pulmonary fibrosis, met its primary endpoint, with TETON 1 data expected in the first half of 2026.

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.

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.

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.

United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2025

United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2025 reports total revenues of $798.6 million for the three months ended June 30, 2025, up from $714.9 million a year earlier, and $1,593.0 million for the six months, versus $1,392.6 million. Net income was $309.5 million for the quarter (diluted EPS $6.41) and $631.7 million for the six months (diluted EPS $13.02). Growth was driven mainly by Tyvaso DPI, whose net product sales rose 22% in the quarter to $315.2 million, and by Orenitram and Unituxin. Remodulin sales declined 9% in the quarter, and the filing notes Liquidia's Yutrepia received FDA approval in May 2025 and launched in June 2025, competing directly with Tyvaso products. The company reported $1,593.1 million in cash and cash equivalents and total cash and marketable investments of $4,966.4 million. Its outstanding balance under the 2025 Credit Agreement, a $2.5 billion unsecured revolver, was zero as of June 30, 2025, after the company repaid the $200.0 million drawn in April. The filing describes significant pending litigation, including a Sandoz judgment with an accrued liability of $71.1 million recorded in 2024 plus $1.5 million accrued through the second quarter of 2025, and an ongoing patent case against Liquidia where trial took place in June 2025. The company also disclosed $21.7 million in impairment of property, plant, and equipment and budgeted approximately $710 million in capital expenditures from the third quarter of 2025 through the end of 2027. On July 25, 2025, the board authorized a $1.0 billion share repurchase program expiring March 31, 2026.

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.

United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2025

United Therapeutics Corporation's first-quarter 2025 Form 10-Q reports total revenues of $794.4 million, up from $677.7 million in the prior-year quarter, with net income of $322.2 million versus $306.6 million. Diluted earnings per share were $6.63 compared with $6.17. Growth was led by Tyvaso DPI, whose net product sales rose to $302.5 million from $227.5 million, while total Tyvaso net product sales reached $466.3 million. Operating income was $382.8 million, and research and development expense increased to $149.0 million from $104.1 million, primarily reflecting a $30.0 million increase in milestone payments for drug delivery device technologies. The balance sheet strengthened over the quarter. Cash and cash equivalents rose to $1,899.9 million, and total cash and marketable investments were $5,032.0 million at March 31, 2025. Operating cash flow was $461.2 million. Total debt under the 2022 Credit Agreement was reduced to $200.0 million, which was then refinanced on April 25, 2025 through a new unsecured revolving credit facility of up to $2.5 billion maturing in 2030, with $200.0 million borrowed and outstanding as of April 30, 2025. The filing highlights material legal and competitive risks. The Sandoz litigation carries an accrued liability of $71.1 million recorded in 2024 plus $0.7 million through the first quarter of 2025, and all parties have appealed. Liquidia received tentative FDA approval for Yutrepia, a dry powder competitor to Tyvaso DPI, with exclusivity expiring May 23, 2025, and a PDUFA goal date of May 24, 2025. Liquidia also filed a new patent infringement lawsuit against Tyvaso DPI on April 21, 2025. The company has budgeted approximately $750 million for capital expenditures from the second quarter of 2025 through 2027, mainly for manufacturing and xenotransplantation facilities.

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.

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.

United Therapeutics Annual Report, Year Ended Dec 31, 2024

United Therapeutics Corporation's 2024 Form 10-K reports total revenues of $2,877.4 million for 2024, up from $2,327.5 million in 2023, with net income of $1,195.1 million (diluted EPS $24.64) compared with $984.8 million in 2023. Growth was led by Tyvaso DPI, whose net product sales rose to $1,033.6 million from $731.1 million, and combined Tyvaso DPI and nebulized Tyvaso sales reached $1,620.4 million, or 56 percent of total revenues. Orenitram ($434.3 million), Remodulin ($538.1 million) and Unituxin ($238.7 million) also grew, while Adcirca declined to $23.8 million amid generic competition. The company is pursuing a pipeline centered on nebulized Tyvaso in idiopathic pulmonary fibrosis (TETON 1 and TETON 2 phase 3 studies) and progressive pulmonary fibrosis (TETON PPF), plus ralinepag in phase 3 (ADVANCE OUTCOMES) and manufactured organ programs, including a UKidney IND cleared by the FDA in January 2025. Management cites risks from Merck's Winrevair, Liquidia's Yutrepia (exclusivity expiring May 2025), generic competition for Remodulin, nebulized Tyvaso and Orenitram, and Inflation Reduction Act pricing pressure. The company also recorded a $71.1 million litigation accrual related to the Sandoz matter and spent $1.0 billion on share repurchases in 2024, leaving $4,742.3 million in cash and marketable investments at year-end against $300.0 million outstanding under its credit agreement. Total research and development expense rose to $481.0 million and selling, general and administrative expense to $709.7 million, with share-based compensation of $144.0 million. Investors will want to watch the Yutrepia launch timing, the outcome of the TETON studies, and the capital program of roughly $750 million budgeted for 2025 through 2027 for facilities.

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.

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.

United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2024

United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2024 reports third-quarter total revenues of $748.9 million, up from $609.4 million, and nine-month revenues of $2.14 billion, up from $1.71 billion. Net income was $309.1 million for the quarter versus $267.6 million a year earlier, and $893.8 million for the nine months versus $767.7 million. Diluted EPS was $6.39 for the quarter and $18.43 for the nine months. Growth was led by Tyvaso DPI, with total Tyvaso net product sales of $433.8 million for the quarter and $1,204.5 million for the nine months. Quarterly operating expenses rose sharply, with selling, general, and administrative expense of $219.2 million including a $65.1 million litigation accrual related to the Sandoz litigation. Research and development expense was $103.5 million for the quarter. Share-based compensation was $117.0 million for the nine months, compared with $22.5 million a year earlier, largely reflecting STAP award remeasurement and higher RSU expense. The company's balance sheet shows cash and cash equivalents of $1,553.9 million and marketable investments of $3,052.0 million combined, totaling $4,605.9 million. During the nine months, the company repurchased $1.0 billion of common stock under an accelerated share repurchase agreement and repaid $300.0 million on its credit line, leaving $400.0 million outstanding. The filing also describes ongoing litigation with Liquidia Technologies over Yutrepia, a pending FDA exclusivity dispute, and several lawsuits involving charitable donations and 340B program policies.

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.

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.

United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2024

United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2024 reports total revenues of $714.9 million for the three months ended June 30, 2024, up from $596.5 million a year earlier, and $1,392.6 million for the six months, up from $1,103.4 million. Net income was $278.1 million for the quarter (diluted EPS $5.85) and $584.7 million for the six months (diluted EPS $12.03). Growth was led by Tyvaso DPI, with total Tyvaso net product sales of $398.2 million for the quarter, and the company attributes the increase mainly to higher quantities sold following the June 2022 launch of Tyvaso DPI and continued growth in PH-ILD utilization. The company's balance sheet shows cash and cash equivalents of $1,355.7 million and total cash and marketable investments of $4,301.9 million at June 30, 2024, down from $4,903.9 million at December 31, 2023, reflecting a $1.0 billion accelerated share repurchase. Treasury stock rose to $3,443.5 million, and the outstanding balance under the Credit Agreement was reduced to $500.0 million, of which $400.0 million is classified as current. Total stockholders' equity was $5,697.2 million. The filing highlights significant ongoing litigation, most notably the Liquidia Technologies matters over Yutrepia, including a pending appeal of a March 2024 order permitting FDA final approval, with oral argument scheduled for September 3, 2024. Other material matters include the Sandoz breach-of-contract damages trial, the MSP Recovery and Humana/United RICO suits, and 340B program litigation. The company also reports pipeline activity, including completed enrollment of the TETON 2 study in IPF and a budgeted approximately $575 million in capital expenditures for the second half of 2024 through 2026.

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.

United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2024

United Therapeutics Corporation's first-quarter 2024 Form 10-Q reports total revenues of $677.7 million, up from $506.9 million in the first quarter of 2023, with Tyvaso DPI net product sales of $227.5 million and total Tyvaso net product sales of $372.5 million. Operating income was $356.3 million versus $284.4 million a year earlier, and net income was $306.6 million, or $6.17 per diluted share, compared with $240.9 million, or $4.86 per diluted share. Selling, general, and administrative expense rose to $144.4 million from $87.3 million, driven partly by a $31.4 million swing in share-based compensation tied to STAP awards and higher legal expenses. The company repurchased common stock through an accelerated share repurchase agreement with Citibank, making an upfront payment of $1.0 billion and receiving 3,275,199 initial shares. Total cash, cash equivalents and marketable investments fell to $4,199.7 million from $4,903.9 million at year-end 2023, and total stockholders' equity declined to $5,338.1 million from $5,984.8 million. The company paid down $100.0 million on its credit agreement, leaving a $600.0 million outstanding balance, of which $400.0 million is classified as current. The filing also details extensive litigation, including the ongoing Sandoz contract damages trial that commenced April 29, 2024, multiple patent and regulatory disputes with Liquidia over Yutrepia, and lawsuits from Humana and United Healthcare filed in state court in April 2024. Pipeline milestones include the TETON studies of nebulized Tyvaso in IPF and PPF and the ADVANCE OUTCOMES study of ralinepag, while the company also reports the first xenotransplantation of a UThymoKidney in a living patient in April 2024.

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.

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.

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.

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.

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.

United Therapeutics Annual Report, Year Ended Dec 31, 2023

United Therapeutics Corporation (Nasdaq: UTHR) reported total revenues of $2,327.5 million for 2023, up from $1,936.3 million in 2022, with net income of $984.8 million and diluted EPS of $19.81. Growth was driven by Tyvaso DPI, which launched commercially in June 2022 and generated $731.1 million in net product sales in 2023, while combined Tyvaso net product sales (Tyvaso DPI and nebulized Tyvaso) reached $1,233.7 million, or 53 percent of total revenues. Nebulized Tyvaso is approved for PH-ILD in the U.S., and the company is running Phase 3 TETON studies in idiopathic pulmonary fibrosis and a TETON PPF study in progressive pulmonary fibrosis. Other products include Remodulin ($494.8 million), Orenitram ($359.4 million), Unituxin ($198.9 million) and Adcirca ($28.9 million), with Adcirca facing generic competition. The balance sheet ended 2023 with cash, cash equivalents and marketable investments of $4,903.9 million against $700.0 million outstanding under the 2022 Credit Agreement, of which $400.0 million is classified as current. Operating cash flow was $978.0 million. The company recorded no share repurchases in 2023. Ralinepag is in the Phase 3 ADVANCE OUTCOMES study, and the company acquired IVIVA Medical and Miromatrix Medical in the fourth quarter of 2023 to expand its manufactured organ programs. Key risks disclosed include generic competition for Remodulin, nebulized Tyvaso and Orenitram, ongoing patent litigation with Liquidia over Yutrepia, the Inflation Reduction Act's effect on Part D revenues, 340B and Medicaid rebate compliance matters, and dependence on a small number of U.S. distributors, which accounted for 51 percent and 34 percent of total revenues in 2023 for Distributors 1 and 2. The company is a Delaware public benefit corporation.

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.

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.

United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2023

United Therapeutics Corporation (UTHR) reported third-quarter 2023 total revenues of $609.4 million, up from $516.0 million in the prior-year quarter, with net income of $267.6 million versus $239.3 million. For the nine months ended September 30, 2023, total revenues were $1,712.8 million and net income was $767.7 million, compared with $1,444.8 million and $595.2 million a year earlier. Growth was led by Tyvaso DPI, whose quarterly net product sales rose to $205.1 million from $63.1 million, partially offset by a decline in nebulized Tyvaso to $120.7 million from $194.6 million. Cash, cash equivalents and marketable investments totaled $4,936.3 million at September 30, 2023, while $800.0 million was outstanding under the Credit Agreement, of which $300.0 million was reclassified as current. The company described its liquidity as sufficient to fund ongoing operations and noted that it has budgeted approximately $650 million in capital expenditures for 2023 through 2025, mainly for a new Tyvaso DPI manufacturing facility in Research Triangle Park, North Carolina. Subsequent events include the October 2023 acquisition of IVIVA Medical, Inc. for an upfront cash payment of approximately $50.0 million, and an October 29, 2023 merger agreement to acquire Miromatrix Medical, Inc. for $3.25 per share in cash, approximately $91.0 million, with contingent value rights of up to $1.75 per share, expected to close in December 2023. The filing also describes ongoing litigation, including the Liquidia patent matter, in which the appellate court affirmed the district court's decision, and a 340B program case that remains pending on appeal.

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.

United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2023

United Therapeutics Corporation, a Delaware public benefit corporation, reported total revenues of $596.5 million for the quarter ended June 30, 2023, up from $466.9 million in the prior-year quarter, and $1,103.4 million for the six months, up from $928.8 million. Tyvaso was the largest driver, with net product sales of $318.9 million in the quarter versus $201.0 million a year earlier, which the filing attributes mainly to patient growth following the commercial launch of Tyvaso DPI and the PH-ILD label expansion. Net income was $259.2 million for the quarter ($5.24 diluted EPS) and $500.1 million for the six months ($10.08 diluted EPS), compared with $116.0 million and $355.9 million in the prior-year periods. Share-based compensation swung sharply because of STAP award remeasurement tied to the stock price decline, which lowered six-month expense to $1.4 million. The balance sheet strengthened, with cash and cash equivalents of $1,067.3 million and total marketable investments of $3,635.3 million, for total cash and investments of $4,702.6 million at June 30, 2023. The company carries $800.0 million outstanding under its Credit Agreement, which provides up to $2.0 billion of unsecured revolving credit and matures in 2028. Management has budgeted approximately $700 million in capital expenditures for 2023 through 2025, mostly for a new Tyvaso DPI manufacturing facility in Research Triangle Park, North Carolina. The filing also details significant legal and regulatory exposure. Liquidia's Yutrepia faces a final judgment barring FDA approval until the '793 patent expires in May 2027, and the appellate court affirmed the district court decision on July 24, 2023. Other matters include the Sandoz antitrust and contract litigation, the MSP Recovery, Humana, and United Healthcare suits, and 340B contract pharmacy litigation. The company states it cannot reasonably estimate potential losses in the Sandoz matter.

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.

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.

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.