UTHR · United Therapeutics
50 filings
UTHR 10-Q Quarterly Reports
United Therapeutics - 50 quarterly reports
UTHR filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 152 current reports (8-K) between 2016 and 2026.
- 8-K · Jan 19, 2016
- 8-K · Feb 1, 2016
- 8-K · Feb 19, 2016
- 8-K · Feb 25, 2016
- 10-K · Feb 25, 2016
- 8-K · Mar 24, 2016
- 10-Q · Apr 28, 2016
- 8-K · Apr 28, 2016
- 8-K · Apr 28, 2016
- 8-K · Jun 22, 2016
- 10-Q · Jul 28, 2016
- 8-K · Jul 28, 2016
- 8-K/A · Sep 27, 2016
- 8-K · Sep 27, 2016
- 8-K · Oct 27, 2016
- 10-Q · Oct 27, 2016
- 8-K · Jan 30, 2017
- 8-K · Feb 3, 2017
- 10-K · Feb 22, 2017
- 8-K · Feb 22, 2017
- 8-K · Mar 31, 2017
- 8-K · Apr 3, 2017
- 10-Q · Apr 26, 2017
- 8-K · Apr 26, 2017
- 8-K · Apr 28, 2017
- 8-K · May 18, 2017
- 8-K · Jun 1, 2017
- 8-K · Jun 29, 2017
- 8-K · Jul 27, 2017
- 10-Q · Jul 27, 2017
- 8-K · Jul 28, 2017
- 8-K · Sep 8, 2017
- 10-Q · Oct 25, 2017
- 8-K · Oct 25, 2017
- 8-K · Dec 20, 2017
- 8-K · Jan 30, 2018
- 8-K · Feb 16, 2018
- 8-K · Feb 21, 2018
- 10-K · Feb 21, 2018
- 8-K · Mar 30, 2018
- 8-K · Apr 30, 2018
- 8-K · May 1, 2018
- 10-Q · May 2, 2018
- 8-K · May 2, 2018
- 8-K · Jun 28, 2018
- 8-K · Jul 20, 2018
- 8-K · Jul 31, 2018
- 10-Q · Aug 1, 2018
- 8-K · Aug 1, 2018
- 8-K · Aug 8, 2018
- 8-K · Aug 9, 2018
- 8-K · Aug 30, 2018
- 8-K · Sep 4, 2018
- 8-K · Sep 17, 2018
- 8-K · Oct 16, 2018
- 8-K · Oct 31, 2018
- 10-Q · Oct 31, 2018
- 8-K · Nov 1, 2018
- 8-K · Nov 15, 2018
- 8-K · Jan 25, 2019
- 8-K · Feb 1, 2019
- 10-K · Feb 27, 2019
- 8-K · Feb 27, 2019
- 8-K · Mar 1, 2019
- 8-K · Apr 8, 2019
- 8-K · May 1, 2019
- 10-Q · May 1, 2019
- 8-K · May 7, 2019
- 8-K · Jun 28, 2019
- 10-Q · Jul 31, 2019
- 8-K · Jul 31, 2019
- 8-K · Sep 11, 2019
- 8-K · Oct 21, 2019
- 8-K · Oct 30, 2019
- 10-Q · Oct 30, 2019
- 8-K · Dec 13, 2019
- 8-K · Feb 3, 2020
- 8-K · Feb 4, 2020
- 8-K · Feb 24, 2020
- 10-K · Feb 26, 2020
- 8-K · Feb 26, 2020
- 8-K · Apr 23, 2020
- 10-Q · Apr 29, 2020
- 8-K · Apr 29, 2020
- 8-K · Jun 5, 2020
- 8-K · Jun 17, 2020
- 8-K · Jun 29, 2020
- 8-K · Jun 29, 2020
- 8-K · Jul 23, 2020
- 10-Q · Jul 29, 2020
- 8-K · Jul 29, 2020
- 8-K · Aug 17, 2020
- 8-K · Sep 11, 2020
- 8-K · Oct 28, 2020
- 10-Q · Oct 28, 2020
- 8-K · Dec 2, 2020
- 8-K · Dec 9, 2020
- 8-K · Dec 28, 2020
- 8-K · Jan 13, 2021
- 8-K · Jan 22, 2021
- 8-K · Jan 28, 2021
- 8-K · Feb 5, 2021
- 8-K · Feb 10, 2021
- 10-K · Feb 24, 2021
- 8-K · Feb 24, 2021
- 8-K · Mar 3, 2021
- 8-K · Apr 1, 2021
- 8-K · Apr 19, 2021
- 8-K · May 5, 2021
- 10-Q · May 5, 2021
- 8-K · Jun 3, 2021
- 8-K · Jun 7, 2021
- 8-K · Jun 16, 2021
- 8-K · Jun 23, 2021
- 8-K · Jun 25, 2021
- 8-K · Aug 4, 2021
- 10-Q · Aug 4, 2021
- 8-K · Oct 1, 2021
- 8-K · Oct 18, 2021
- 10-Q · Nov 3, 2021
- 8-K · Nov 3, 2021
- 8-K · Dec 27, 2021
- 8-K · Jan 18, 2022
- 8-K · Feb 24, 2022
- 10-K · Feb 24, 2022
- 8-K · Apr 1, 2022
- 8-K · Apr 22, 2022
- 10-Q · May 4, 2022
- 8-K · May 4, 2022
- 8-K · May 24, 2022
- 8-K · Jun 28, 2022
- 10-Q · Aug 3, 2022
- 8-K · Aug 3, 2022
- 8-K · Sep 1, 2022
- 8-K · Sep 20, 2022
- 8-K · Oct 11, 2022
- 10-Q · Nov 2, 2022
- 8-K · Nov 2, 2022
- 8-K · Jan 9, 2023
- 8-K · Feb 22, 2023
- 10-K · Feb 22, 2023
- 8-K · Mar 31, 2023
- 8-K · Apr 21, 2023
- 8-K · May 3, 2023
- 10-Q · May 3, 2023
- 8-K · Jun 28, 2023
- 8-K/A · Jul 14, 2023
- 8-K · Jul 24, 2023
- 10-Q · Aug 2, 2023
- 8-K · Aug 2, 2023
- 10-Q · Nov 1, 2023
- 8-K · Nov 1, 2023
- 8-K · Nov 29, 2023
- 8-K · Dec 20, 2023
- 10-K · Feb 21, 2024
- 8-K · Feb 21, 2024
- 8-K · Feb 27, 2024
- 8-K · Mar 25, 2024
- 8-K · Mar 29, 2024
- 8-K · May 1, 2024
- 10-Q · May 1, 2024
- 8-K · Jun 27, 2024
- 10-Q · Jul 31, 2024
- 8-K · Jul 31, 2024
- 8-K · Oct 30, 2024
- 10-Q · Oct 30, 2024
- 8-K · Jan 13, 2025
- 8-K · Feb 26, 2025
- 10-K · Feb 26, 2025
- 8-K · Apr 28, 2025
- 10-Q · Apr 30, 2025
- 8-K · Apr 30, 2025
- 8-K · Jun 27, 2025
- 8-K · Jul 30, 2025
- 10-Q · Jul 30, 2025
- 8-K · Aug 1, 2025
- 8-K · Sep 2, 2025
- 8-K · Oct 29, 2025
- 10-Q · Oct 29, 2025
- 8-K · Jan 22, 2026
- 10-K · Feb 25, 2026
- 8-K · Feb 25, 2026
- 8-K · Mar 2, 2026
- 8-K · Mar 9, 2026
- 8-K · Mar 30, 2026
- 10-Q · May 6, 2026
- 8-K · May 6, 2026
- 8-K · Jun 29, 2026
- 8-K · Jul 23, 2026
- 10-Q · Aug 5, 2026
- 8-K · Aug 5, 2026
- 8-K · Sep 8, 2026
- 8-K · Oct 14, 2026
- 8-K · Oct 22, 2026
- 10-Q · Nov 4, 2026
- 8-K · Nov 4, 2026
- 2026-Q3Nov 4, 2026
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2026
- 2026-Q2Aug 5, 2026
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.
- 2026-Q1May 6, 2026
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.
- 2025-Q3Oct 29, 2025
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.
- 2025-Q2Jul 30, 2025
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.
- 2025-Q1Apr 30, 2025
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.
- 2024-Q3Oct 30, 2024
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.
- 2024-Q2Jul 31, 2024
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.
- 2024-Q1May 1, 2024
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.
- 2023-Q3Nov 1, 2023
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.
- 2023-Q2Aug 2, 2023
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.
- 2023-Q1May 3, 2023
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2023
United Therapeutics Corporation reported first-quarter 2023 total revenues of $506.9 million, up from $461.9 million in the prior-year quarter, a change the filing states as 10%. Net income was $240.9 million versus $239.9 million, and diluted net income per share was $4.86 versus $5.03. Growth came mainly from Tyvaso, whose net product sales rose to $238.4 million from $172.0 million, a 39% increase the filing attributes to higher quantities sold following the June 2022 launch of Tyvaso DPI. Remodulin, Unituxin, and Adcirca declined, and Orenitram rose to $88.2 million. Cost of sales more than doubled to $52.3 million, which the filing attributes primarily to Tyvaso DPI royalty expense and product costs, and research and development expense rose to $82.9 million, driven by the TETON clinical studies of Tyvaso in idiopathic pulmonary fibrosis. At March 31, 2023, cash and cash equivalents were $1,163.5 million and total cash and marketable investments were $4,629.0 million. The company had $800.0 million outstanding under its Credit Agreement, which provides up to $2.0 billion of unsecured revolving credit. Operating cash flow was $374.8 million. The company expects to spend approximately $750 million on capital expenditures over 2023 through 2025, mostly on a new Tyvaso DPI manufacturing facility in Research Triangle Park, North Carolina, to be funded from cash on hand. Significant legal matters remain open. In the Liquidia patent litigation, oral argument on the appeal of the district court judgment was scheduled for May 3, 2023, and the court judgment bars FDA approval of Liquidia's product until the '793 patent expires in May 2027, subject to appeals and a pending stay motion. The company also faces the Sandoz breach of contract damages trial, which the filing says is likely in summer 2023, and several RICO-based suits concerning patient assistance donations. The filing states the company cannot reasonably estimate potential losses in the Sandoz matter.
- 2022-Q3Nov 2, 2022
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2022
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2022 reports third-quarter total revenues of $516.0 million, up from $444.7 million a year earlier, with net product sales of $516.0 million. Nine-month total revenues were $1,444.8 million versus $1,270.3 million, and nine-month net income was $595.2 million, compared with $363.6 million in the prior-year period. Diluted EPS was $4.91 for the quarter and $12.35 for the nine months. Tyvaso was the main growth driver, with net product sales of $257.7 million in the quarter versus $164.2 million, reflecting the PH-ILD label expansion and the June 2022 commercial launch of Tyvaso DPI. Remodulin, Unituxin and Adcirca sales declined year over year in the quarter. The balance sheet remained strong, with cash and cash equivalents of $966.8 million and marketable investments totaling $3,092.6 million at September 30, 2022. The company borrowed $800.0 million under its 2022 Credit Agreement in March 2022 to repay its 2018 facility, and that balance remained outstanding as a non-current liability. Operating cash flow for the nine months was $674.3 million. The filing also describes ongoing litigation: a federal court ruled in August 2022 that Liquidia infringed the '793 patent, which bars FDA approval of Liquidia's product until May 2027, and both sides have appealed. The Sandoz antitrust case has gone to a damages trial on the contract claim, and the 340B contract pharmacy case is awaiting an appellate decision.
- 2022-Q2Aug 3, 2022
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2022
United Therapeutics Corporation (UTHR) reported total revenues of $466.9 million for the three months ended June 30, 2022, up from $446.5 million a year earlier, and $928.8 million for the six months ended June 30, 2022, compared with $825.6 million in the prior-year period. Net product sales from Tyvaso rose to $201.0 million in the quarter from $153.8 million, while Adcirca declined to $10.4 million from $23.6 million amid generic competition. Net income was $116.0 million for the quarter versus $172.6 million a year earlier, and $355.9 million for the six months versus $200.9 million. The quarter's results were affected by share-based compensation of $65.5 million, driven by an increase in STAP award expense tied to a 31 percent rise in the company's stock price during the period. The balance sheet strengthened, with total cash, cash equivalents and marketable investments of $3,897.1 million at June 30, 2022, compared with $3,580.6 million at December 31, 2021. The company entered into a 2022 Credit Agreement in March 2022 providing up to $2.0 billion in unsecured revolving credit, of which $800.0 million was borrowed and remained outstanding at quarter end, classified as non-current. Tyvaso DPI received FDA approval on May 24, 2022 for PAH and PH-ILD and began commercial shipments to distributors in June 2022. Litigation remains a key focus. A trial with Liquidia Technologies over Yutrepia was held in March 2022, with a decision expected before the 30-month stay expires in October 2022. The PTAB issued a final written decision in July 2022 finding all claims of the '793 patent unpatentable, and the company has the right to appeal. The company also disclosed a settlement with ANI Pharmaceuticals regarding generic Orenitram, with no payment by either party, permitting generic entry in December 2027 or earlier in some circumstances.
- 2022-Q1May 4, 2022
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2022
United Therapeutics Corporation reported total revenues of $461.9 million for the three months ended March 31, 2022, up from $379.1 million a year earlier, a 22% increase as stated in the filing. Net product sales were $451.9 million, led by Tyvaso at $172.0 million, up 40%. Net income rose to $239.9 million, or $5.03 per diluted share, compared with $28.3 million, or $0.61 per diluted share, in the prior-year quarter. Research and development expense fell to $69.0 million from $303.7 million, which the filing attributes mainly to a $107.3 million in-process R&D impairment and a $105.0 million priority review voucher purchase recorded in the first quarter of 2021. Share-based compensation was a benefit of $21.1 million, driven by a 17 percent decline in the company's stock price during the quarter. On March 31, 2022, the company entered into a 2022 Credit Agreement providing unsecured revolving facilities of up to $2.0 billion, maturing in 2027, and borrowed $800.0 million to repay its 2018 facilities. Cash and cash equivalents were $813.3 million, and total cash and marketable investments were $3,826.8 million at March 31, 2022. Operating cash flow was $288.7 million. Key pending matters include the FDA review of the Tyvaso DPI new drug application, with a decision anticipated in May 2022 after the review deadline was extended. The company also awaits a court decision in its patent litigation with Liquidia, expected between June and October 2022, and continues to defend the Sandoz, MSP Recovery, ANI, and 340B program litigation.
- 2021-Q3Nov 3, 2021
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2021
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2021 shows third-quarter total revenues of $444.7 million, up from $380.1 million, and nine-month revenues of $1,270.3 million, up from $1,098.4 million. Net income was $162.7 million for the quarter (diluted EPS $3.42) versus $171.2 million a year earlier, and $363.6 million for the nine months versus $416.0 million. Nine-month R&D expense rose to $457.2 million from $231.6 million, driven by a $107.3 million IPR&D impairment for Trevyent, a $105.0 million priority review voucher purchase, and an $11.6 million facility impairment. Selling, general, and administrative expense increased to $339.1 million for the nine months, including legal and consulting cost increases and higher share-based compensation tied to STAP awards. The balance sheet at September 30, 2021 showed cash and cash equivalents of $908.5 million and total marketable investments of $2.6 billion, for total cash and investments of $3,509.1 million, against $800.0 million outstanding under the Credit Agreement. Operating cash flow was $423.6 million for the nine months, down from $629.5 million, reflecting the priority review voucher purchase, higher income tax payments, and higher STAP settlements. On September 30, 2021, the company converted to a Delaware public benefit corporation. The filing highlights several pending developments: on October 15, 2021, the FDA issued a complete response letter declining to approve the Tyvaso DPI NDA, citing a single deficiency related to a third-party analytical testing facility. Ongoing litigation includes the Sandoz antitrust case, patent litigation with Liquidia over LIQ861 (trial set for March 2022), patent litigation with ANI over Orenitram, the MSP Recovery class action, and a 340B program dispute with HRSA and HHS.
- 2021-Q2Aug 4, 2021
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2021
United Therapeutics Corporation's 10-Q for the quarter ended June 30, 2021 reports total revenues of $446.5 million for the second quarter, up from $362.0 million, and $825.6 million for the six months, up from $718.3 million. Net income was $172.6 million for the quarter versus $107.1 million a year earlier, and $200.9 million for the six months versus $244.8 million. Six-month results were shaped by large non-recurring items: a $107.3 million impairment of in-process R&D for Trevyent, a $105.0 million priority review voucher purchase, and a $91.9 million realized gain on the sale of a publicly traded equity investment. Operating cash flow for the six months was $238.0 million, compared with $378.6 million a year earlier, and cash, cash equivalents and marketable investments totaled $3.29 billion at June 30, 2021. Tyvaso was the largest growth driver, with net product sales of $153.8 million in the quarter, up from $119.2 million, following FDA approval in March 2021 for PH-ILD. Management anticipates continued revenue growth in the second half of 2021 from Tyvaso, Orenitram, and modest price increases, partly offset by possible further generic erosion of Adcirca. The company filed an NDA for Tyvaso DPI in April 2021, with FDA action anticipated in October 2021. It discontinued several programs during the period, including Trevyent for the U.S. market, the Implantable System for Remodulin with Medtronic, and Unexisome. The filing also details ongoing litigation, including the Sandoz antitrust case, patent litigation with Liquidia Technologies over LIQ861 (trial set for March 2022), patent litigation with ANI Pharmaceuticals over Orenitram, and a suit against HRSA and HHS over 340B contract pharmacy policies. The company disclosed a proposed conversion to a Delaware public benefit corporation, subject to a shareholder vote later in 2021.
- 2021-Q1May 5, 2021
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2021
United Therapeutics Corporation's first-quarter 2021 Form 10-Q reports net product sales of $379.1 million, up from $356.3 million a year earlier, with Tyvaso ($123.0 million, up from $102.9 million) and Unituxin ($43.9 million, up from $26.6 million) growing while Remodulin ($130.2 million, down from $145.3 million) and Adcirca ($9.6 million, down from $12.5 million) declined. Operating results swung to an operating loss of $64.8 million, compared with operating income of $166.7 million a year earlier, driven by research and development expense of $303.7 million. That expense included a $107.3 million impairment of the Trevyent in-process R&D asset after the company decided to discontinue U.S. development, a $105.0 million priority review voucher purchase, a $15.5 million facility-related impairment within R&D, and a $6.1 million impairment tied to discontinuing biomechanical lungs work. Net income fell to $28.3 million, or $0.61 per diluted share, from $137.7 million, though other income, net of $97.2 million, included a $91.9 million realized gain on sale of an equity investment. The balance sheet remained liquid, with cash and cash equivalents of $832.3 million and marketable investments totaling $2,332.5 million at March 31, 2021, against $800.0 million outstanding under the Credit Agreement, which matures in December 2025. Operating cash flow was $89.8 million, down from $214.6 million, largely reflecting the priority review voucher purchase and higher STAP award cash settlements. Management expects revenue growth in 2021, driven by Tyvaso's expanded label for PH-ILD approved in March 2021, continued Orenitram growth, and modest price increases, partly offset by generic erosion of Adcirca. The filing also highlights ongoing litigation and competitive risk. Sandoz and RareGen antitrust litigation continues, Liquidia's LIQ861 NDA is subject to a patent infringement suit with a Tyvaso trial set for March 2022, and ANI Pharmaceuticals filed a Paragraph IV challenge against Orenitram, which the company has sued upon. A Tyvaso DPI NDA was submitted in April 2021, and management anticipates FDA action in December 2021 if the NDA is accepted.
- 2020-Q3Oct 28, 2020
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2020
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2020 reports third-quarter net product sales of $380.1 million, down from $401.5 million a year earlier, and nine-month net product sales of $1.10 billion versus $1.14 billion. Total revenues for the quarter were $380.1 million, and operating income was $221.1 million compared with $183.4 million in the prior-year quarter. Net income for the quarter was $171.2 million, or $3.84 per diluted share, versus $132.4 million, or $3.01 per diluted share, a year earlier. For the nine months, the company reported net income of $416.0 million, compared with a net loss of $157.1 million in 2019, a swing driven largely by the $800.0 million upfront payment to Arena Pharmaceuticals recorded in the first quarter of 2019. Revenue trends were mixed by product. Remodulin sales fell in both periods, Tyvaso, Orenitram and Unituxin grew, and Adcirca declined on generic competition. The filing notes that new patient starts for treprostinil-based products returned to pre-pandemic levels by the end of the third quarter. Share-based compensation was a benefit of $12.5 million in the quarter because of a decline in the company's stock price, which reduced the liability for share tracking awards. Cash and cash equivalents plus marketable investments totaled $2.81 billion at September 30, 2020, up from $2.25 billion at year-end 2019, while the credit facility balance was $800.0 million. The filing highlights several pipeline and legal developments. The FDA accepted the supplemental NDA for Tyvaso based on the INCREASE study, with review expected to be completed in April 2021. The company received a complete response letter for Trevyent and plans to resubmit in 2021. In patent litigation with Liquidia Technologies, the PTAB instituted review of one Remodulin-related patent and declined to institute review of another, and the district court set a trial date of March 28, 2022. The Sandoz antitrust suit is in discovery, with no trial expected before late 2021.
- 2020-Q2Jul 29, 2020
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2020
United Therapeutics Corporation's quarterly report for the period ended June 30, 2020 shows net product sales of $362.0 million in the second quarter, down from $373.6 million a year earlier, and $718.3 million for the six months, down from $736.2 million. Net income was $107.1 million for the quarter versus $205.1 million in the prior-year quarter, and $244.8 million for the six months versus a net loss of $289.5 million in 2019, a period that included an $800.0 million upfront payment to Arena Pharmaceuticals for ralinepag. Decline in Remodulin and Adcirca sales reflected generic competition and, in the second quarter, reduced new patient starts during the COVID-19 pandemic, partly offset by growth in Orenitram and Unituxin. The balance sheet remained strong, with cash, cash equivalents and marketable investments totaling $2,570.1 million at June 30, 2020, against $800.0 million outstanding under the Credit Agreement. The company reclassified its $800.0 million credit line balance to non-current liabilities, as it no longer intends to repay any portion within one year, citing caution around COVID-19. Share-based compensation rose sharply in the quarter, driven by STAP award expense tied to a 28 percent increase in the stock price. Management highlighted several pipeline and regulatory developments: an sNDA for Tyvaso in PH-ILD was submitted in June 2020 after positive INCREASE study results, the Trevyent NDA received a complete response letter, and the company filed a patent infringement lawsuit against Liquidia Technologies over its LIQ861 NDA, which carries a PDUFA target date of November 24, 2020. The Sandoz antitrust litigation continues in discovery.
- 2020-Q1Apr 29, 2020
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2020
United Therapeutics Corporation's first-quarter 2020 10-Q reports net product sales of $356.3 million, down from $362.6 million a year earlier, with the filing stating revenues decreased by $6.3 million. Net income was $137.7 million, or $3.12 per diluted share, compared with a net loss of $494.6 million in the prior-year quarter, which was driven by an $800.0 million upfront payment to Arena Pharmaceuticals for ralinepag recorded as R&D expense. Operating income was $166.7 million versus an operating loss of $655.9 million a year earlier. Cash, cash equivalents and marketable investments totaled $2,412.5 million at March 31, 2020, and the company repaid $50.0 million on its credit facility, leaving $800.0 million outstanding. The filing is heavily shaped by COVID-19. Management states it is no longer able to predict whether full-year 2020 net revenues will grow compared to 2019, citing reduced new patient prescriptions and starts in April 2020. The company says it has enough cash to fund operations for at least two years regardless of future revenues, and it reports sufficient inventory of its treprostinil-based products for two years at current demand. Enrollment has been paused in most clinical studies, and the Remunity pump launch remains targeted for July 2020. Key risk items include generic competition for Remodulin, Adcirca and, in future years, Tyvaso and Orenitram; a Liquidia NDA for LIQ861 that has been accepted with a PDUFA date of November 24, 2020; a Sandoz antitrust suit; and an FDA complete response letter for Trevyent in April 2020, which may trigger an impairment of the $107.3 million in-process R&D asset.
- 2019-Q3Oct 30, 2019
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2019
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2019 shows net product sales of $401.5 million for the three months ended September 30, 2019, versus $412.7 million a year earlier, and $1,137.7 million for the nine months versus $1,246.4 million. The decline is driven entirely by Adcirca, whose sales fell following generic competition beginning in August 2018; Remodulin, Tyvaso, Orenitram and Unituxin all grew in both periods. Net income was $132.4 million for the quarter, but the nine-month result was a net loss of $157.1 million, reflecting an $800.0 million upfront payment to Arena Pharmaceuticals for ralinepag, which was expensed as acquired in-process research and development within research and development expense. The balance sheet shows total cash, cash equivalents and marketable investments of $2,300.4 million at September 30, 2019, against $1,858.5 million at December 31, 2018. Total debt under the Credit Agreement stands at $1.0 billion, with $250.0 million classified as current. Operating cash flow was negative $309.1 million for the nine months, compared with positive $693.0 million a year earlier, largely due to the Arena payment. The filing also flags generic competition for Remodulin in the United States (Sandoz launched in March 2019, with other generic approvals following) and in certain European countries, and it describes ongoing litigation brought by Sandoz and RareGen alleging anticompetitive conduct. The company states that it expects revenues to decrease in 2019 compared with 2018, and that it expects a return to revenue growth potentially as soon as 2020. Subsequent to quarter-end, the FDA approved the Orenitram label update based on FREEDOM-EV results on October 18, 2019, and the company discontinued its SOUTHPAW study of Orenitram.
- 2019-Q2Jul 31, 2019
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2019
United Therapeutics Corporation's quarterly report for the period ended June 30, 2019 shows a sharp swing to a net loss for the first half of 2019, driven by an $800.0 million upfront payment to Arena Pharmaceuticals for the ralinepag license, which was expensed as acquired in-process research and development. Total revenues were $373.6 million for the three months ended June 30, 2019, versus $444.5 million a year earlier, and $736.2 million for the six months, versus $833.7 million. The filing attributes the decline mainly to generic competition for Adcirca, whose net product sales fell to $29.1 million in the quarter from $109.8 million, and to lower Remodulin international pricing as generics launched in the United States in March 2019 and in certain European countries. Net income was $205.1 million for the quarter, or $4.66 diluted earnings per share, compared with $172.9 million a year earlier, helped by a $37.2 million share-based compensation benefit tied to a 33 percent decline in the stock price in the quarter and a $29.5 million unrealized gain on publicly traded equity securities. For the six months, the company reported a net loss of $289.5 million, or $6.61 per share. Operating cash flow was negative $494.5 million for the six months, and the company drew $800.0 million under its credit agreement to fund the Arena payment, bringing its outstanding balance to $1,050.0 million, of which $250.0 million is classified as current. Cash, cash equivalents and marketable investments totaled $2,206.9 million at June 30, 2019. The filing also highlights pipeline and legal developments, including the resubmission of the Trevyent NDA in June 2019, the DISTINCT phase III study of Unituxin in small cell lung cancer (results expected by the first quarter of 2020), and a lawsuit filed by Sandoz and RareGen alleging anticompetitive conduct related to Remodulin cartridges. The company stated it cannot reasonably estimate potential losses from that litigation at this stage.
- 2019-Q1May 1, 2019
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2019
United Therapeutics Corporation's first quarter 2019 Form 10-Q reports a net loss of $494.6 million, compared with net income of $244.5 million in the first quarter of 2018. The swing was driven primarily by an $800.0 million upfront payment to Arena Pharmaceuticals for the exclusive license to ralinepag, which was expensed as acquired in-process research and development within research and development expenses. Total revenues were $362.6 million, down from $389.2 million, as a $77.6 million decline in Adcirca sales following generic competition offset increases in Remodulin, Tyvaso, Orenitram and Unituxin. The company's balance sheet and liquidity changed meaningfully. It borrowed $800.0 million under its Credit Agreement to fund the Arena payment, bringing the outstanding line of credit to $1,050.0 million as of March 31, 2019, up from $250.0 million at December 31, 2018. Cash and cash equivalents rose to $790.6 million, and total cash and marketable investments were $2,016.4 million. Net cash used in operating activities was $627.4 million for the quarter. Share-based compensation expense was $29.2 million, reflecting an increase in STAP liability tied to a rise in the company's stock price. Competitive pressure is intensifying. Generic Remodulin launched in the United States in late March 2019 by Sandoz, with other generic entrants possible as early as September 2019, and generic Remodulin launched in Austria in January 2019. Management expects 2019 revenues to decrease compared with 2018, citing a full year of generic Adcirca competition. The company also disclosed a newly filed lawsuit by Sandoz and RareGen alleging anticompetitive conduct, and it reported that its phase III BEAT study of esuberaprost failed its primary endpoint in April 2019.
- 2018-Q3Oct 31, 2018
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2018
United Therapeutics Corporation's quarterly report for the period ended September 30, 2018 shows net product sales of $412.7 million for the three months, down from $445.5 million a year earlier, and $1,246.4 million for the nine months, compared with $1,260.6 million in the prior-year period. Net income was $106.5 million for the quarter versus $276.3 million, and $523.9 million for the nine months versus $398.9 million. The quarterly decline was driven by a $25.2 million decrease in Adcirca net product sales following the August 2018 launch of a generic version, and by higher research and development expense ($101.1 million versus $55.0 million) and selling, general and administrative expense ($110.1 million versus $47.2 million), which included a swing in share-based compensation tied to the Share Tracking Awards Plan liability. The filing states the company expects 2018 revenues to decrease compared with 2017, citing the Adcirca generic launch, a lower Remodulin transfer price to an international distributor, and reimbursement challenges for oral therapies. The balance sheet shows cash, cash equivalents and marketable investments totaling $1,833.5 million at September 30, 2018, up from $1,430.1 million at December 31, 2017, while the company drew $250.0 million on its credit facility and entered a new unsecured revolving credit agreement providing up to $1.5 billion. Operating cash flow was $660.0 million for the nine months. Key 2018 events included the acquisition of SteadyMed Ltd. for a preliminary purchase price of $141.2 million, the August 2018 settlement with Watson Laboratories on a generic Tyvaso that permits generic entry beginning January 2026, and the September 2018 license agreement with MannKind for Treprostinil Technosphere, under which the company paid $45.0 million after the agreement became effective on October 15, 2018. The filing also reports an $12.4 million impairment on an investment in a privately-held company during the quarter and a $75.0 million contingent consideration obligation tied to the SteadyMed Trevyent milestone. The company's Implantable System for Remodulin received FDA approval on July 30, 2018, with a U.S. launch pending the availability of initial pump supply from Medtronic.
- 2018-Q2Aug 1, 2018
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2018
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2018 reports net product sales of $444.5 million for the three months ended June 30, 2018, essentially flat with $444.6 million a year earlier, and $833.7 million for the six months, up from $815.1 million. Net income was $172.9 million for the quarter versus a net loss of $56.0 million in the prior-year quarter, which included a $210.0 million loss contingency accrual. Six-month net income was $417.4 million, compared with $122.6 million in 2017. Share-based compensation was a benefit of $80.6 million for the six months, driven by a decline in the STAP liability tied to the lower stock price, which flows through operating expenses and makes results volatile. The filing signals pressure ahead. The company expects 2018 revenues to decrease compared with 2017, citing anticipated generic competition for Adcirca beginning in the second half of 2018, reimbursement challenges for oral therapies, and a launch of generic Remodulin in certain European countries. Adcirca's royalty to Eli Lilly rose to an effective rate of approximately 42.5 percent from five percent beginning December 1, 2017, which lifted cost of product sales to $114.9 million for the six months from $33.2 million. Watson Laboratories' ANDA litigation over Tyvaso remains pending, with a PTAB final written decision expected by January 2019. Liquidity remained solid, with cash, cash equivalents and marketable investments totaling $1,791.3 million at June 30, 2018. The company entered a $1.5 billion unsecured revolving credit facility in June 2018, of which $250.0 million was drawn, and agreed to acquire SteadyMed Ltd. for approximately $141.0 million in cash plus up to $75.0 million in contingent consideration, with closing expected in the third quarter of 2018. The FDA approved the Implantable System for Remodulin on July 30, 2018, with initial launch supply limited by Medtronic.
- 2018-Q1May 2, 2018
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2018
United Therapeutics Corporation reported net income of $244.5 million for the quarter ended March 31, 2018, compared with $178.6 million in the prior-year period, on total revenues of $389.2 million versus $370.5 million. Revenue growth was driven by Adcirca price increases set by Lilly, higher Orenitram patient counts, and Tyvaso pricing, partially offset by a $19.0 million decline in Remodulin net product sales. Net income also benefited from a $101.1 million share-based compensation benefit, driven largely by a $115.0 million benefit from share tracking awards, reflecting the lower stock price at quarter end ($112.36 versus $147.95 at December 31, 2017). Cost of product sales rose to $53.2 million from $14.3 million, mainly due to a $37.3 million increase in Adcirca royalty expense following the amended Lilly license. The filing highlights significant near-term generic competition. The company expects revenues to decrease in 2018 as compared to 2017, with generic Adcirca expected after loss of regulatory exclusivity in May 2018 and generic Remodulin from Sandoz as early as June 2018, with Teva, Par and Dr. Reddy's from December 2018. The company expects revenue growth to resume in 2019. Cash and marketable investments totaled $1,671.6 million at March 31, 2018, against $250.0 million outstanding on the revolving credit facility. Subsequent to quarter end, on April 29, 2018, United Therapeutics agreed to acquire SteadyMed Ltd. for $4.46 per share in cash plus a contingent value right of $2.63 per share, with aggregate cash consideration expected to be approximately $141.0 million and contingent consideration up to $75.0 million. Completion is expected in the third quarter of 2018, subject to closing conditions including HSR clearance.
- 2017-Q3Oct 25, 2017
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2017
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2017 shows third-quarter net product sales of $445.5 million, up from $408.2 million a year earlier, and nine-month net product sales of $1,260.6 million versus $1,189.8 million. Third-quarter net income was $276.3 million, compared with $161.8 million in the prior-year quarter, while nine-month net income fell to $398.9 million from $603.4 million. The nine-month decline reflects a $210.0 million estimated loss contingency accrued in the second quarter related to a U.S. Department of Justice investigation into the company's support of 501(c)(3) patient assistance organizations, and $49.6 million of impairment charges on cost method investments. The company states it is engaged in settlement negotiations with the DOJ, with any settlement expected to include a payment and possibly a corporate integrity agreement. The filing highlights patent and generic exposure as a central investor concern. Sandoz may launch generic Remodulin in June 2018 and Teva, Par and Dr. Reddy's in December 2018, and generic Adcirca competition is expected after the November 2017 patent expiry. Litigation against Watson (Tyvaso) and Actavis (Orenitram) is ongoing, and the SteadyMed IPR appeal on the '393 patent is scheduled for oral argument on November 7, 2017. Balance sheet strength improved, with cash and cash equivalents of $1,067.5 million and total marketable investments of $1,549.2 million at September 30, 2017, against a $250.0 million drawn line of credit used to fund a $250.0 million accelerated share repurchase. Operating expenses were affected by a $47.2 million SG&A figure for the quarter, which included share tracking awards plan benefits, and by higher research and development spending on the pipeline, which rose to $151.0 million for nine months from $80.7 million. The company also reported a Tyvaso one-time Medicaid rebate liability of $12.2 million recorded in the third quarter and a one-time $47.4 million Remodulin inventory purchase by an international distributor that contributed to quarterly revenue growth.
- 2017-Q2Jul 27, 2017
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2017
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2017 shows a quarter with a large one-time charge. Total revenues were $444.6 million for the three months ended June 30, 2017, up from $412.6 million a year earlier, driven by Adcirca net product sales of $120.6 million (up from $90.9 million) and Orenitram of $46.0 million. However, the company recorded a $210.0 million estimated loss contingency related to the U.S. Department of Justice investigation into its support of 501(c)(3) patient assistance organizations, and a $46.5 million impairment of a cost method investment. As a result, the company reported a net loss of $56.0 million, or $(1.25) per diluted share, for the quarter, compared with net income of $206.1 million in the prior-year quarter. Six-month net income was $122.6 million, versus $441.6 million a year earlier. Operating expenses also rose, with research and development expense of $59.8 million for the quarter versus $35.2 million in 2016, reflecting expanded pipeline programs. Share-based compensation was a benefit for the six months ($21.0 million), driven by the share tracking awards liability falling with the stock price. Cash and cash equivalents plus marketable investments totaled $1,331.4 million at June 30, 2017, up from $1,053.1 million at December 31, 2016, after the company drew $250.0 million on its $1.0 billion revolving credit facility to fund a $250.0 million accelerated share repurchase program. Investors should weigh the DOJ settlement, which the company says is under negotiation and may include a settlement payment and a corporate integrity agreement, against ongoing generic competition. Generic Adcirca is expected after the November 2017 patent expiry, and generic Remodulin is expected from Sandoz in June 2018 and from Teva, Par and Dr. Reddy's in December 2018. The company also faces patent litigation over Tyvaso and Orenitram, and an appeal of a PTAB decision invalidating a key treprostinil patent.
- 2017-Q1Apr 26, 2017
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2017
United Therapeutics Corporation's Form 10-Q for the quarter ended March 31, 2017 reports total revenues of $370.5 million, essentially flat compared with $369.0 million in the prior-year quarter. Net income fell to $178.6 million from $235.5 million, and diluted EPS was $3.89 versus $4.84. The decline in earnings was driven largely by a swing in share-based compensation: a benefit of $19.1 million this quarter versus a benefit of $144.6 million in Q1 2016, which increased operating expenses. Operating income was $263.6 million compared with $363.7 million a year earlier. By product, Adcirca rose to $80.0 million (primarily on price increases set by Eli Lilly), Remodulin grew to $145.8 million, and Unituxin reached $18.0 million. Tyvaso declined to $87.4 million from $102.2 million, which the company attributes to the availability of oral prostacyclin-class therapies. Cash and cash equivalents plus marketable investments totaled $1.30 billion at March 31, 2017, and the company had no drawings on its $1.0 billion revolving credit facility. The filing highlights significant intellectual property and regulatory risk. Generic Remodulin entry is scheduled for June 2018 (Sandoz) and December 2018 (Teva and Par), a new generic filer, Dr. Reddy's, submitted an ANDA in April 2017, and the Adcirca patent expires in November 2017. The PTAB issued a Final Written Decision finding all claims of the '393 patent unpatentable, and the company is evaluating an appeal. The company also disclosed a Department of Justice subpoena concerning its support of 501(c)(3) patient assistance organizations.
- 2016-Q3Oct 27, 2016
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2016
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2016 shows third-quarter net product sales of $408.2 million, up from $384.7 million a year earlier, with total revenues of $408.2 million versus $386.2 million. Net income fell to $161.8 million from $464.4 million, largely because the prior-year quarter included a $350.0 million gain on sale of a Rare Pediatric Priority Review Voucher and because share-based compensation swung from a benefit of $121.6 million to an expense of $45.8 million, reflecting the 11 percent rise in the company's stock price during the quarter versus a 25 percent decline a year earlier. Nine-month net income was $603.4 million, up from $547.0 million, on total revenues of $1,189.8 million, and operating cash flow rose to $480.2 million from $357.3 million. Balance sheet strength improved: cash, cash equivalents and marketable investments totaled $1,034.9 million at September 30, 2016, and the company repurchased about 3.3 million shares for $395.5 million in the first nine months under a $500.0 million program running through December 31, 2016. The company's $250.0 million convertible notes matured in September 2016, and a $1.0 billion unsecured revolving credit facility remained undrawn. The filing highlights significant intellectual property risk. Sandoz and Teva settled litigation over generic Remodulin, permitting launches in June 2018 and December 2018, and Par Sterile Products filed a Paragraph IV notice in October 2016. Litigation against Watson (Tyvaso) and Actavis (Orenitram) is pending, and SteadyMed's inter partes review of the '393 patent was instituted with the PTAB preliminarily finding a reasonable likelihood SteadyMed would prevail. Adcirca faces generic competition after patent expiry in November 2017. The FDA issued a complete response letter on October 13, 2016 for the Remodulin NDA for use with the Implantable System for Remodulin, pending Medtronic's PMA.
- 2016-Q2Jul 28, 2016
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2016
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2016 reports a strong second quarter, with total revenues of $412.6 million for the three months ended June 30, 2016, up from $347.2 million, and net income of $206.1 million versus $99.2 million a year earlier. Net product sales growth was led by Adcirca ($90.9 million, up from $68.2 million), Remodulin ($158.9 million, up from $135.9 million), Orenitram ($38.0 million, up from $25.9 million) and Unituxin ($17.8 million, its first quarter of sales following its 2015 launch), partially offset by Tyvaso ($107.0 million, down from $115.8 million). Six-month net income was $441.6 million, boosted by a $143.1 million share-based compensation benefit, reflecting the decline in the company's share price and its cash-settled Share Tracking Awards Plan liability. The balance sheet shows cash, cash equivalents and marketable investments of $948.6 million at June 30, 2016, down from $991.8 million at year-end 2015, as the company used $259.7 million to repurchase common stock under a $500.0 million program running through December 31, 2016. The company has an undrawn $1.0 billion unsecured revolving credit facility entered into in January 2016. Operating cash flow was $251.5 million for the six months. The filing highlights significant patent and competitive risks. Sandoz and Teva settled Remodulin generic litigation with generic entry permitted in June 2018 and December 2018, respectively. Watson (Tyvaso) and Actavis (Orenitram) have filed ANDAs and are being sued by the company, and SteadyMed's inter partes review of the '393 patent was instituted with the PTAB preliminarily agreeing with SteadyMed's invalidity arguments. The company also disclosed a May 2016 Department of Justice subpoena concerning its support of 501(c)(3) patient assistance organizations, and a Medtronic PMA for the Remodulin Implantable System that the FDA deemed not approvable in March 2016.
- 2016-Q1Apr 28, 2016
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2016
United Therapeutics Corporation reported first-quarter 2016 results with total revenues of $369.0 million, up from $327.5 million in the prior-year quarter, driven by Adcirca ($72.6 million, up from $45.3 million), Orenitram ($40.2 million, up from $20.9 million) and first Unituxin sales of $14.2 million, partially offset by lower Tyvaso ($102.2 million vs. $113.4 million) and Remodulin ($139.8 million vs. $146.3 million) sales. Net income was $235.5 million, or $4.84 diluted per share, compared with a net loss of $16.6 million in the prior-year period. The swing is driven largely by share-based compensation, which was a benefit of $144.6 million in cash-flow terms and reflects a 29% decline in the company's stock price during the quarter; the benefit is tied to the cash-settled Share Tracking Awards Plan, whose liability fell to $193.4 million from $354.7 million. The company ended the quarter with cash, cash equivalents and marketable investments of $985.8 million and entered a $1.0 billion unsecured revolving credit facility in January 2016, with no amounts drawn as of March 31, 2016. It repurchased approximately 1.0 million shares for $123.2 million under its $500.0 million program for 2016. Operating expenses were minimal this quarter, with $37.0 million of charitable donations to a non-profit PAH patient-assistance organization recorded in general and administrative expense. Investors should weigh the revenue growth against the pending generic and patent challenges: Sandoz and Teva may launch generic Remodulin in June 2018 and December 2018 under settlements, Watson and Actavis have filed challenges to Tyvaso and Orenitram patents, and SteadyMed's inter partes review of a Remodulin-related patent was instituted in April 2016 with preliminary findings favoring SteadyMed. Medtronic's PMA for the Remodulin Implantable System received a not-approvable letter from the FDA in March 2016.
- 2015-Q3Oct 27, 2015
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2015
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2015 reports third-quarter total revenues of $386.2 million, up from $330.0 million a year earlier, and net income of $464.4 million, compared with a net loss of $25.2 million in the prior-year quarter. The largest driver of the result was a $350.0 million gain on the sale of a Rare Pediatric Priority Review Voucher to AbbVie Ireland Unlimited Company, which was recognized as a gain on sale of an intangible asset. Nine-month net income was $547.0 million, and net cash provided by operating activities was $357.2 million. Share-based compensation swung to a benefit of $121.6 million in the quarter, reflecting a 25 percent decline in the stock price during the period, which reduced operating expenses. Product revenue growth came mainly from Adcirca (up 44.0 percent in the quarter) and Orenitram (up 137.8 percent), while Remodulin rose 5.0 percent and Tyvaso rose 1.7 percent. Unituxin began U.S. commercial sales in the third quarter with $4.7 million in net revenue. Cash, cash equivalents and marketable securities were $1,008.1 million at September 30, 2015. The company repurchased $394.5 million of stock in the first nine months and settled early conversions of $107.1 million in convertible notes. The filing also highlights patent and generic competition risks. The company settled litigation with Sandoz on September 29, 2015, permitting Sandoz to market a generic Remodulin beginning June 26, 2018, although earlier entry is possible in certain circumstances. Litigation with Teva (Remodulin) and Watson (Tyvaso) is ongoing, and SteadyMed filed an inter partes review petition on October 1, 2015 seeking to invalidate a treprostinil patent.
- 2015-Q2Jul 28, 2015
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2015
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2015 reports total revenues of $347.2 million for the three months ended June 30, 2015, up from $322.8 million a year earlier, with net income of $99.2 million compared with $111.9 million. For the six months, total revenues were $674.7 million and net income was $82.6 million, versus $249.4 million in the prior-year period. The filing attributes the six-month net income decline largely to share-based compensation: the company's STAP liability is cash-settled and re-measured with its stock price, which rose 34 percent in the six months ended June 30, 2015, producing a six-month share-based compensation expense of $281.8 million, compared with a benefit in 2014. Orenitram revenue grew strongly, and the company reported an estimated annual effective tax rate of approximately 42 percent for 2015. Cash, cash equivalents and marketable securities fell to $556.2 million from $812.8 million at December 31, 2014, primarily reflecting $336.8 million of share repurchases and $104.3 million used to settle early conversions of Convertible Notes, partly offset by $149.9 million of operating cash flow. Remaining repurchase authorization under the $500.0 million program was $57.6 million at June 30, 2015, and the company expected to substantially exhaust it by its August 1, 2015 expiration. The company discontinued STAP awards on June 26, 2015, when shareholders approved the 2015 Stock Incentive Plan. The filing also details ongoing patent litigation against generic challengers Sandoz, Teva and Watson over Remodulin and Tyvaso, with the FDA precluded from approving those ANDAs for up to 30 months under the Hatch-Waxman Act. Unituxin received FDA approval in March 2015, with U.S. commercial sales commencing in the third quarter of 2015 and a positive EMA opinion in May 2015.
- 2015-Q1Apr 28, 2015
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2015
United Therapeutics Corporation's first quarter 2015 Form 10-Q shows total revenues of $327.5 million, up 13.2% from $289.4 million in the first quarter of 2014, led by Remodulin ($146.3 million), Tyvaso ($113.4 million), Adcirca ($45.4 million) and the newly launched Orenitram ($20.9 million). The company reported a net loss of $16.6 million, or $(0.36) per diluted share, versus net income of $137.5 million in the prior-year quarter. The swing was driven mainly by share-based compensation expense of $234.5 million, which is tied to the rising share tracking award (STAP) liability as the stock price increased 33 percent during the quarter to $172.44. Research and development expense rose to $110.2 million from $12.4 million and selling, general and administrative expense rose to $211.3 million from $30.2 million, largely from the same share-based compensation effect. Operating cash flow was $109.0 million, roughly flat year over year. Cash, cash equivalents and marketable securities were $768.0 million at March 31, 2015, down $44.8 million from year-end, after $152.3 million of share repurchases. The company has $242.2 million remaining under its $500.0 million repurchase authorization. Convertible notes due 2016 were reduced to a $124.8 million principal balance, and $89.4 million of conversion requests received in March are to be settled in cash in the second quarter of 2015. On the regulatory and legal side, the FDA approved Unituxin on March 10, 2015, with U.S. sales expected in the second half of 2015. The Department of Justice closed its investigation related to a subpoena received in December 2013. Patent litigation against Sandoz and Teva over Remodulin continues in the U.S. District Court for the District of New Jersey, and the FDA issued a refuse-to-file letter for the Remodulin Implantable System NDA, which the company is working to resubmit.
- 2014-Q3Oct 28, 2014
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2014
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2014 shows third-quarter net revenues of $329.95 million, up from $302.23 million a year earlier, but the company reported a net loss of $25.2 million, compared with net income of $62.7 million in the prior-year quarter. The swing reflects operating expenses of $362.2 million, including share-based compensation tied to the stock price increase, which the filing attributes to a rise in STAP award liabilities. Remodulin, Tyvaso, Adcirca and the newly launched Orenitram together drove product sales of $328.3 million for the quarter. For the nine months, net income was $224.1 million on total revenues of $942.2 million. Cash, cash equivalents and marketable securities fell to $968.2 million from $1,136.7 million at December 31, 2013, mainly because of $403.2 million in share repurchases, $177.7 million in estimated tax payments and $97.9 million for cash-settled STAP award exercises. The company also received conversion requests for $101.3 million of its 1.0% Convertible Senior Notes due 2016, which will be settled in cash in October 2014 and are classified as a current liability. The filing describes ongoing patent litigation with Sandoz and Teva over generic Remodulin, a Department of Justice-linked subpoena from the HHS Office of Inspector General concerning marketing practices, and the expiration of a royalty obligation to GlaxoSmithKline in October 2014.
- 2014-Q2Jul 29, 2014
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2014
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2014 reports total revenues of $322.8 million for the second quarter, up from $280.6 million a year earlier, with net product sales of $321.3 million led by Remodulin ($138.2 million), Tyvaso ($121.2 million) and Adcirca ($55.3 million). Orenitram, launched in the quarter, contributed $6.6 million. Operating income rose to $176.3 million from $122.3 million, and net income was $111.9 million, or $2.10 per diluted share, compared with $79.9 million, or $1.52 per diluted share, a year earlier. Results were significantly affected by share-based compensation: the company recognized a benefit of $2.1 million in the quarter because its stock price declined, versus expense of $29.1 million in the prior-year quarter. For the six months, net income was $249.4 million on total revenues of $612.2 million. The balance sheet shows cash, cash equivalents and marketable securities (excluding restricted amounts) of $760.0 million at June 30, 2014, down from $1,136.7 million at December 31, 2013, largely due to $377.6 million of share repurchases. The company drew $75.0 million on its Wells Fargo line of credit to help fund those repurchases, and the convertible notes due 2016 became convertible at holders' election, so they are classified as a current liability. The company completed its $420.0 million 2013 repurchase program in the second quarter and authorized an additional $500.0 million program effective August 1, 2014. Legal matters remain significant. The company is cooperating with a civil investigation by the Department of Justice and HHS Office of Inspector General concerning Remodulin, Tyvaso and Adcirca marketing practices. Litigation with Sandoz over Remodulin patents went to trial in May and June 2014 with a decision pending, and Teva filed a Paragraph IV notice on Remodulin in July 2014.
- 2014-Q1Apr 29, 2014
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2014
United Therapeutics Corporation's 10-Q for the quarter ended March 31, 2014 reports total revenues of $289.4 million, up from $245.1 million in the prior-year quarter, with net product sales of $284.6 million led by Remodulin ($136.1 million), Tyvaso ($107.1 million) and Adcirca ($41.4 million). Operating income was $216.1 million versus $94.0 million, and net income was $137.5 million, or $2.43 per diluted share, compared with $62.3 million, or $1.19 per diluted share. The filing attributes much of the profit swing to share-based compensation: a $60.7 million benefit, driven by a 17 percent decline in the stock price, versus $35.2 million of expense in the prior-year quarter. Investors should therefore treat reported earnings as sensitive to the share price through the share tracking award (STAP) liability. Balance sheet and cash flow were strong. Cash and cash equivalents rose to $413.8 million, and net cash from operations was $110.6 million. The company repurchased 1,027,369 shares for $97.6 million during the quarter and had $279.9 million remaining under its 2013 Repurchase Program, which was extended through March 3, 2015. The 2016 Convertible Notes ($250.0 million principal) became convertible at holders' election and were classified as a current liability, and the Sandoz patent litigation on Remodulin is set for trial in May 2014. The filing also discloses a Department of Health and Human Services subpoena, received in December 2013, relating to marketing practices for Remodulin, Tyvaso and Adcirca. Pipeline and regulatory milestones include the April 2014 commercial launch of Orenitram in the United States, the March 2014 Japanese approval of Remodulin, the planned Mochida sales of Treprost in Japan, an FDA biologics license application for ch14.18 submitted in April 2014, and an ongoing phase III FREEDOM-EV study of Orenitram.
- 2013-Q3Oct 29, 2013
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2013
United Therapeutics Corporation's 10-Q for the quarter ended September 30, 2013 reports total revenues of $302.2 million for the third quarter, up from $242.5 million a year earlier, driven by net product sales of Remodulin ($132.3 million), Tyvaso ($120.3 million) and Adcirca ($47.4 million). Net income for the quarter was $62.7 million, or $1.17 per diluted share, compared with $78.1 million, or $1.46 per diluted share, in the prior-year quarter. The prior-year period included a $31.0 million gain from insurance proceeds, and share-based compensation rose sharply to $61.5 million for the quarter (from $27.1 million) because of the increase in the company's stock price, weighing on operating expenses. For the nine months, total revenues were $828.0 million and net income was $204.9 million. The balance sheet and liquidity remain strong, with cash, cash equivalents and marketable investments (excluding restricted amounts) totaling $1,038.8 million at September 30, 2013, versus $784.9 million at year-end 2012. The $250.0 million 1.0% Convertible Senior Notes due 2016 became convertible at holders' option and were reclassified to current liabilities at $213.0 million carrying value, and $37.0 million of equity was moved to temporary equity. The company also entered into a $75.0 million revolving credit facility with Wells Fargo on September 26, 2013, which had not been drawn as of quarter-end. Pipeline and legal developments include Medtronic reporting that the primary objective of its DelIVery trial of the SynchroMed II pump with Remodulin was met, the FDA's acceptance of a second resubmission of the oral treprostinil NDA with a user fee goal date of February 16, 2014 after two prior complete response letters, and ongoing patent litigation with Sandoz over generic Remodulin, under which the FDA is precluded from approving Sandoz's ANDA for up to 30 months from notice receipt or until an adverse district court decision.
- 2013-Q2Jul 25, 2013
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2013
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2013 reports total revenues of $280.6 million for the three months ended June 30, 2013, up from $225.6 million a year earlier, and net income of $79.9 million versus $72.3 million. For the six months, total revenues were $525.7 million and net income was $142.2 million, compared with $143.1 million in the prior-year period, which the company attributes largely to higher share-based compensation expense of $58.6 million tied to its share tracking award plans (STAP), which are settled in cash and rise with the stock price. Net product sales were led by Remodulin ($124.3 million in the quarter), Tyvaso ($109.5 million) and Adcirca ($43.7 million). Balance-sheet highlights include cash and cash equivalents of $343.6 million and total marketable investments of $551.1 million, against $210.2 million of current convertible notes. The 1.0% 2016 Convertible Notes became convertible at holders' election because the stock price exceeded 130 percent of the conversion price for more than 20 trading days, so they were reclassified to current liabilities. The company also repurchased 708,998 shares for $42.4 million under a $420.0 million authorization. The filing also describes pipeline and legal developments: FDA issued a second complete response letter in March 2013 declining to approve oral treprostinil, with the company now targeting approval no later than 2017 via the FREEDOM-EV trial. Sandoz has filed ANDAs seeking generic versions of Remodulin, and the company has sued Sandoz for patent infringement.
- 2013-Q1Apr 25, 2013
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2013
United Therapeutics Corporation's first-quarter 2013 results show total revenues of $245.1 million, up from $204.2 million in the prior-year quarter, a 20.0% increase. Net product sales were $243.1 million, led by Tyvaso at $94.6 million (up 35.1%), Remodulin at $114.7 million (up 3.7%), and Adcirca at $33.8 million (up 51.5%). Net income fell to $62.3 million from $70.8 million, and diluted EPS was $1.19 versus $1.29, mainly because share-based compensation rose to a $29.5 million expense from a $2.0 million benefit as the company's stock price appreciated. Operating income declined to $94.0 million from $106.7 million. The balance sheet strengthened, with cash, cash equivalents and marketable investments (excluding restricted amounts) totaling $876.8 million at March 31, 2013, compared with $784.9 million at December 31, 2012. Operating cash flow was $97.7 million versus $37.6 million a year earlier. The Board authorized a share repurchase program of up to $420.0 million effective March 4, 2013, and the company had bought 99,100 shares for $5.9 million under it by quarter-end. Regulatory and litigation developments were material. The FDA issued a second complete response letter in March 2013 declining to approve the oral treprostinil NDA, and the company says it remains committed to approval no later than 2017. Sandoz has filed ANDAs for generic Remodulin, and the company has sued Sandoz in the U.S. District Court for the District of New Jersey, which could preclude FDA approval of Sandoz's ANDA for up to 30 months under the Hatch-Waxman Act. Investors should also note that Baxter's formulation contract for Remodulin will be terminated when it expires at the end of 2013, with the company expecting to negotiate a new agreement.
- 2012-Q3Nov 1, 2012
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2012
United Therapeutics Corporation's third-quarter 2012 Form 10-Q shows net product sales of $240.9 million for the three months ended September 30, 2012, up from $201.0 million a year earlier, and total revenues of $242.5 million versus $201.7 million. Nine-month total revenues were $672.3 million versus $548.0 million. Operating income for the quarter was $80.7 million, compared with $103.0 million in the prior-year quarter, as selling, general and administrative expense rose to $68.6 million from $16.7 million, driven largely by share-based compensation tied to the share price appreciation under its share tracking awards plans. Net income was $78.1 million, or $1.46 per diluted share, versus $84.4 million, or $1.38 per diluted share, a year earlier. Results were helped by an approximately $31.0 million gain from a Lexington Insurance Company settlement over damaged Remodulin inventory. The balance sheet was strengthened by cash and cash equivalents of $263.4 million and marketable investments of $240.0 million current and $248.9 million non-current at September 30, 2012. The company repurchased $130.9 million of common stock during the nine months, including $42.9 million under a $100.0 million program effective July 31, 2012. Its $250.0 million 1.0 percent convertible notes due 2016 remain outstanding. The most significant regulatory development is the October 23, 2012 FDA complete response letter declining approval of the oral treprostinil NDA. The company is assessing the letter and aims to obtain approval for oral treprostinil before the end of 2016, with the FREEDOM-EV phase III study enrolling patients. The Sandoz patent litigation over a generic version of Remodulin is ongoing, with the FDA precluded from approving the ANDA for up to 30 months under the Hatch-Waxman Act or until an adverse district court decision.
- 2012-Q2Jul 26, 2012
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2012
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2012 reports total revenues of $225.6 million for the three months ended June 30, 2012, up from $183.8 million a year earlier, with net income of $72.3 million compared to $73.9 million. For the six months, total revenues were $429.8 million and net income was $143.1 million, versus $90.3 million in the prior-year period. Net product sales were led by Remodulin ($110.4 million in the quarter), Tyvaso ($81.2 million) and Adcirca ($30.2 million). Operating income for the quarter was $105.6 million, down from $114.5 million, reflecting higher selling, general and administrative expense of $53.3 million, which included a $6.8 million impairment charge on a contract-based intangible asset and higher share-based compensation. The balance sheet shows cash, cash equivalents and marketable investments (excluding restricted amounts) of $701.3 million at June 30, 2012, versus $747.4 million at December 31, 2011, as the company repurchased common stock for $88.0 million and spent $83.9 million on property, plant and equipment. Property, plant and equipment rose to $435.8 million. The company completed a $300 million share repurchase program in May 2012 and authorized an additional $100 million program that becomes effective July 31, 2012. The filing also describes pending litigation and pipeline developments. The company sued Sandoz Inc. for patent infringement over Remodulin after a Paragraph IV notice, and filed suit against Lexington Insurance Company over damaged Remodulin inventory with an estimated net commercial value of $65.0 million. The oral treprostinil NDA was accepted for review with a standard 10-month review period, and the FREEDOM-EV phase III trial was planned to begin enrollment in the third quarter of 2012.
- 2012-Q1Apr 26, 2012
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2012
United Therapeutics Corporation's first-quarter 2012 Form 10-Q reports total revenues of $204.2 million, up 25.7% from $162.5 million in the first quarter of 2011, driven by Tyvaso ($70.1 million, up 46.9%) and Adcirca ($22.3 million, up 97.3%), while Remodulin rose 7.1% to $110.5 million. Operating income was $106.7 million versus $36.8 million a year earlier, and net income was $70.8 million, or $1.29 per diluted share, compared with $16.4 million, or $0.26 per diluted share. The large improvement was largely due to a $20.8 million decline in SG&A share-based compensation and a $15.9 million decline in R&D share-based compensation, which the company attributes to the lower share price. Net cash provided by operating activities was $37.6 million, and cash and marketable investments remained substantial. The filing highlights pipeline and legal events. The company submitted a New Drug Application for oral treprostinil in December 2011, with the FDA reviewing it under a standard 10-month period, and it is planning a new phase III trial, FREEDOM-EV. Sandoz filed an ANDA seeking to market a generic 10 mg/mL Remodulin, and United Therapeutics sued Sandoz for patent infringement on March 14, 2012, which automatically precludes FDA approval of the ANDA for up to 30 months. The company also sued Lexington Insurance Company on April 9, 2012 to recover the net commercial value of damaged Remodulin inventory, estimated at approximately $65.0 million. Balance sheet items include working capital of $398.4 million, $252.3 million of current marketable investments, and $196.7 million of carrying value for the 1.0% Convertible Senior Notes due 2016 with a $250.0 million principal balance. The company's $300.0 million share repurchase program had $88.0 million remaining, and it expects to begin open-market repurchases in the second quarter of 2012.
- 2011-Q3Oct 27, 2011
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2011
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2011 reports total revenues of $201.7 million for the third quarter, up from $168.6 million a year earlier, driven by net product sales of Remodulin, Tyvaso and Adcirca. Net income for the quarter was $84.4 million, or $1.38 per diluted share, compared with $39.7 million in the prior-year quarter. For the nine months, revenues were $548.0 million and net income was $174.7 million. Operating expenses were affected by share tracking award (STAP) liability swings, which produced a share-based compensation benefit of $47.6 million in the quarter, and by a $46.3 million charge tied to a July 2011 amended license agreement with Toray for beraprost-MR. Cash, cash equivalents and marketable investments (excluding restricted amounts) totaled $944.6 million at September 30, 2011. After the quarter ended, the company issued $250.0 million of 1.0% Convertible Senior Notes due 2016 on October 17, 2011, used to fund a $212.0 million accelerated share repurchase under a $300.0 million buyback program authorized October 3, 2011, and to pay for a call spread hedge. The 2011 Convertible Senior Notes matured on October 15, 2011, with $250.0 million of principal repaid in cash. The company also reported that its FREEDOM-M Phase III trial of oral treprostinil met its primary endpoint, while FREEDOM-C2 did not achieve statistical significance, and it plans to file a New Drug Application for oral treprostinil no later than the first quarter of 2012. The filing also notes that a limited number of distributors account for most revenue, with three U.S.-based distributors representing 81 percent of total net revenues for the quarter. The pending combination of Express Scripts (parent of CuraScript) and Medco (parent of Accredo) could reduce the number of U.S. specialty distributors to two if completed as announced.
- 2011-Q2Jul 28, 2011
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2011
United Therapeutics Corporation's 10-Q for the quarter ended June 30, 2011 reports total revenues of $183.8 million for the three months ended June 30, 2011, up from $134.7 million a year earlier, and $346.3 million for the six months, versus $260.6 million. Net product sales for the quarter were led by Remodulin at $104.9 million, Tyvaso at $61.8 million and Adcirca at $16.8 million. Net income for the quarter was $73.9 million, or $1.18 per diluted share, compared with $37.7 million a year earlier. Six-month net income was $90.3 million, after a $3.0 million loss on the disposal of Medicomp, Inc., the telemedicine subsidiary sold in March 2011. Cash, cash equivalents and marketable investments (excluding restricted amounts) were $887.4 million at June 30, 2011, up from $759.9 million at December 31, 2010. Net cash provided by operating activities was $117.9 million for the six months. Investors should note the $250.0 million Convertible Senior Notes mature on October 15, 2011, and the company states its current liquidity is sufficient to repay them. Other items include a $50.0 million non-refundable beraprost-MR payment to Toray to be expensed in the third quarter, FREEDOM-M trial results showing a median six-minute walk improvement of about 23 meters versus placebo, and the July 11, 2011 acquisition of Revivicor, Inc. The filing also highlights concentration risk: Remodulin and Tyvaso accounted for 60 percent and 32 percent of total revenues for the six months, and three U.S.-based distributors represented 83 percent of net revenues. A pending Express Scripts and Medco Health Solutions merger could leave only two specialty distributors for these products.
- 2011-Q1Apr 28, 2011
United Therapeutics Quarterly Report for Q1 Ended Mar 31, 2011
United Therapeutics Corporation's first-quarter 2011 Form 10-Q shows total revenues of $165.6 million for the three months ended March 31, 2011, up from $128.9 million in the prior-year period, with net product sales of $162.2 million. Net income was $16.4 million, or $0.26 per diluted share, compared with $18.9 million, or $0.32 per diluted share, a year earlier. The decline in profit reflects higher operating expenses, including research and development of $48.0 million (versus $34.9 million) and selling, general and administrative expense of $59.2 million (versus $46.9 million), as well as a $5.3 million loss on the sale of Medicomp, Inc. recorded in other, net. Remodulin revenue was $103.2 million, Tyvaso $47.7 million and Adcirca $11.3 million in the quarter. Cash, cash equivalents and marketable investments (excluding restricted amounts) totaled $824.6 million at March 31, 2011, up from $759.9 million at December 31, 2010, and net cash provided by operating activities was $53.4 million. Share tracking awards (STAP) liability rose to $145.7 million from $125.6 million, and the company's $250.0 million of 0.50% Convertible Senior Notes mature in October 2011, which management says current liquidity is sufficient to repay. The filing also covers pipeline and regulatory items, including the FREEDOM-M and FREEDOM-C2 oral treprostinil Phase III trials, with preliminary results expected in June and September 2011, respectively. The company also disclosed the 2011 STAP plan authorizing up to 2,000,000 awards and expansion projects at its Research Triangle Park facility and Silver Spring headquarters campus.
- 2010-Q3Oct 28, 2010
United Therapeutics Quarterly Report for Q3 Ended Sep 30, 2010
United Therapeutics Corporation's Form 10-Q for the quarter ended September 30, 2010 reports total revenues of $171.0 million for the three months ended September 30, 2010, up from $97.2 million a year earlier, and net income of $39.7 million versus $11.9 million. For the nine months, total revenues were $437.4 million compared with $260.9 million, and net income was $96.4 million versus $22.8 million. Net product sales drove the growth, with Remodulin, Tyvaso and Adcirca all contributing; the filing attributes the increase to more patients being prescribed the company's products and to March and April 2010 Remodulin price increases. Income from operations for the nine months was $155.0 million, compared with $28.2 million. The balance sheet strengthened over the period. Cash, cash equivalents and marketable investments (excluding restricted amounts) totaled $625.9 million at September 30, 2010, versus $378.1 million at December 31, 2009, and working capital was $201.0 million compared with a deficit of $5.7 million. Net cash provided by operating activities was $172.3 million for the nine months. The $250.0 million 0.50% Convertible Senior Notes due October 2011 are classified as a current liability because they are convertible at holders' election, and the filing states most are expected to be held to maturity. The filing also discloses a stipulation of settlement, dated October 25, 2010, resolving a shareholder derivative lawsuit concerning the Share Tracking Awards Plan and option exchanges. Under the settlement the company agreed not to reprice awards without shareholder approval, to cancel 165,214 options held by its Chief Executive Officer, and to adopt certain governance practices; a court hearing is scheduled for January 21, 2011. The company also reports that its share tracking awards liability rose to $98.4 million, which is a cash-settled obligation that will grow with the stock price.
- 2010-Q2Jul 28, 2010
United Therapeutics Quarterly Report for Q2 Ended Jun 30, 2010
United Therapeutics Corporation's Form 10-Q for the quarter ended June 30, 2010 shows total revenues of $137.5 million for the three months ended June 30, 2010, up from $84.0 million a year earlier, with net income of $37.7 million compared with a net loss of $2.3 million in the prior-year quarter. Net product sales were $134.5 million, driven by Remodulin ($96.4 million), the newly launched Tyvaso ($29.5 million), and Adcirca ($8.6 million). For the six months, total revenues were $266.4 million and net income was $56.6 million. Operating results were helped by a $4.0 million benefit tied to the reduced estimated value of a potential CEO stock option grant, and share-based compensation was lower overall as the stock price declined from March 31 to June 30, 2010. The balance sheet strengthened over the period. Cash and cash equivalents rose to $285.4 million from $100.4 million at December 31, 2009, and cash, cash equivalents and marketable investments (excluding restricted amounts) totaled $514.8 million. Stockholders' equity increased to $782.3 million. The $250.0 million 0.50% Convertible Senior Notes due October 2011 are classified as a current liability because they are convertible at holders' option, and the lease obligation for the Phase I Laboratory is now current because its initial term ends in May 2011. The company also disclosed that it exercised a put option to sell its remaining auction-rate securities for $19.0 million par value, with settlement on July 1, 2010, and that it reached an agreement in principle to settle consolidated derivative lawsuits related to share-based award repricing and the CEO's stock options. The filing also notes regulatory and operational items relevant to investors: the Tyvaso PMR and PMCs, the FREEDOM-M and FREEDOM-C2 Phase III oral treprostinil trials, the potential impact of the Patient Protection and Affordable Care Act (with a stated Medicaid rebate increase from 15.1 percent to 23.1 percent that management estimates will reduce 2010 net revenues by less than one percent), and a concentration of revenues in three U.S.-based distributors, which accounted for 82 percent of total net revenues in the quarter.