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UTHR · United Therapeutics

27 filings

10-K

UTHR 10-K Annual Reports

United Therapeutics - 27 annual reports

Filing record · 2016–202610-K1110-Q338-K152

2025
United Therapeutics Annual Report, Year Ended Dec 31, 2025
United Therapeutics Corporation (UTHR) reported total revenues of $3,182.7 million for 2025, up from $2,877.4 million in 2024 and $2,327.5 million in 2023. Net income was $1,334.7 million in 2025, compared with $1,195.1 million in 2024, and diluted earnings per share were $27.86, versus $24.64 in 2024. Growth was driven primarily by Tyvaso DPI, whose net product sales reached $1,292.5 million, and by Orenitram, with $496.9 million in net product sales. Combined Tyvaso DPI and Nebulized Tyvaso net product sales were $1,878.2 million, representing 59 percent of total revenues. Remodulin, Unituxin, and Adcirca are the company's other marketed products. The company ended 2025 with cash and cash equivalents of $1,557.1 million and total marketable investments of $3,140.0 million, for combined cash and investments of $4,697.0 million. It had no outstanding balance on its $2.5 billion unsecured revolving credit facility at year end. Cash from operating activities was $1,561.2 million. The company repurchased $1.0 billion of common stock under 2025 accelerated share repurchase agreements, and it expects to spend approximately $400 million on capital expenditures during 2026 through 2028, mainly on manufacturing and xenotransplantation facilities. Key pipeline events are the TETON 1 Phase 3 readout for Nebulized Tyvaso in IPF, expected late in the first quarter or early in the second quarter of 2026, and the ADVANCE OUTCOMES topline data for ralinepag, expected on a similar timeline. The filing also highlights competitive and legal risks, including the launch of Liquidia's Yutrepia in June 2025, Merck's Winrevair, generic competition for Remodulin, and ongoing litigation with Liquidia and Sandoz, which has an accrued liability of $74.1 million.
Feb 25, 2026
2024
United Therapeutics Annual Report, Year Ended Dec 31, 2024
United Therapeutics Corporation's 2024 Form 10-K reports total revenues of $2,877.4 million for 2024, up from $2,327.5 million in 2023, with net income of $1,195.1 million (diluted EPS $24.64) compared with $984.8 million in 2023. Growth was led by Tyvaso DPI, whose net product sales rose to $1,033.6 million from $731.1 million, and combined Tyvaso DPI and nebulized Tyvaso sales reached $1,620.4 million, or 56 percent of total revenues. Orenitram ($434.3 million), Remodulin ($538.1 million) and Unituxin ($238.7 million) also grew, while Adcirca declined to $23.8 million amid generic competition. The company is pursuing a pipeline centered on nebulized Tyvaso in idiopathic pulmonary fibrosis (TETON 1 and TETON 2 phase 3 studies) and progressive pulmonary fibrosis (TETON PPF), plus ralinepag in phase 3 (ADVANCE OUTCOMES) and manufactured organ programs, including a UKidney IND cleared by the FDA in January 2025. Management cites risks from Merck's Winrevair, Liquidia's Yutrepia (exclusivity expiring May 2025), generic competition for Remodulin, nebulized Tyvaso and Orenitram, and Inflation Reduction Act pricing pressure. The company also recorded a $71.1 million litigation accrual related to the Sandoz matter and spent $1.0 billion on share repurchases in 2024, leaving $4,742.3 million in cash and marketable investments at year-end against $300.0 million outstanding under its credit agreement. Total research and development expense rose to $481.0 million and selling, general and administrative expense to $709.7 million, with share-based compensation of $144.0 million. Investors will want to watch the Yutrepia launch timing, the outcome of the TETON studies, and the capital program of roughly $750 million budgeted for 2025 through 2027 for facilities.
Feb 26, 2025
2023
United Therapeutics Annual Report, Year Ended Dec 31, 2023
United Therapeutics Corporation (Nasdaq: UTHR) reported total revenues of $2,327.5 million for 2023, up from $1,936.3 million in 2022, with net income of $984.8 million and diluted EPS of $19.81. Growth was driven by Tyvaso DPI, which launched commercially in June 2022 and generated $731.1 million in net product sales in 2023, while combined Tyvaso net product sales (Tyvaso DPI and nebulized Tyvaso) reached $1,233.7 million, or 53 percent of total revenues. Nebulized Tyvaso is approved for PH-ILD in the U.S., and the company is running Phase 3 TETON studies in idiopathic pulmonary fibrosis and a TETON PPF study in progressive pulmonary fibrosis. Other products include Remodulin ($494.8 million), Orenitram ($359.4 million), Unituxin ($198.9 million) and Adcirca ($28.9 million), with Adcirca facing generic competition. The balance sheet ended 2023 with cash, cash equivalents and marketable investments of $4,903.9 million against $700.0 million outstanding under the 2022 Credit Agreement, of which $400.0 million is classified as current. Operating cash flow was $978.0 million. The company recorded no share repurchases in 2023. Ralinepag is in the Phase 3 ADVANCE OUTCOMES study, and the company acquired IVIVA Medical and Miromatrix Medical in the fourth quarter of 2023 to expand its manufactured organ programs. Key risks disclosed include generic competition for Remodulin, nebulized Tyvaso and Orenitram, ongoing patent litigation with Liquidia over Yutrepia, the Inflation Reduction Act's effect on Part D revenues, 340B and Medicaid rebate compliance matters, and dependence on a small number of U.S. distributors, which accounted for 51 percent and 34 percent of total revenues in 2023 for Distributors 1 and 2. The company is a Delaware public benefit corporation.
Feb 21, 2024
2022
United Therapeutics Annual Report, Year Ended Dec 31, 2022
United Therapeutics Corporation (UTHR) reported total revenues of $1,936.3 million for 2022, up from $1,685.5 million in 2021 and $1,483.3 million in 2020. Net income was $727.3 million in 2022, compared with $475.8 million in 2021, and diluted earnings per share were $15.00, versus $10.06 in 2021. Growth was led by Tyvaso, whose net product sales rose to $873.0 million, driven by the June 2022 commercial launch of Tyvaso DPI and continued growth following the March 2021 PH-ILD label expansion. Orenitram net product sales were $325.1 million, Remodulin $500.2 million, Unituxin $182.9 million, and Adcirca $41.3 million, which the company attributed to generic competition. The company ended 2022 with cash, cash equivalents and marketable investments totaling $4,154.9 million, against $800.0 million outstanding under its 2022 Credit Agreement, which matures in March 2027. Management states that current liquidity is sufficient to fund operations. Key risks highlighted include generic competition (Watson/Nebulized Tyvaso from January 2026, Actavis/Orenitram from June 2027, ANI/Orenitram from December 2027), ongoing patent litigation with Liquidia over its proposed Yutrepia product, changes under the Inflation Reduction Act of 2022, and several pending legal matters including 340B program litigation, the Sandoz antitrust case, and RICO lawsuits related to patient assistance donations. The filing also describes pipeline programs, including the TETON studies of Tyvaso in idiopathic pulmonary fibrosis, the phase 3 ADVANCE studies of ralinepag, and organ manufacturing research. The company also disclosed that it is a Delaware public benefit corporation, having converted in 2021.
Feb 22, 2023
2021
United Therapeutics Annual Report, Year Ended Dec 31, 2021
United Therapeutics Corporation (Nasdaq: UTHR) reported net product sales of $1.69 billion for 2021, up from $1.48 billion in 2020, with net income of $475.8 million compared with $514.8 million in 2020. Tyvaso led growth at $607.5 million (up from $483.3 million), reflecting the March 2021 approval of Tyvaso for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Remodulin sales were roughly flat at $513.7 million, Orenitram rose to $306.1 million, Unituxin increased to $202.3 million, and Adcirca declined to $55.9 million amid generic competition. Operating expenses rose, driven by a $107.3 million impairment of in-process R&D tied to discontinuing U.S. development of Trevyent, a $105.0 million priority review voucher purchase, and higher litigation expenses. The company completed its conversion to a Delaware public benefit corporation on September 30, 2021. As of December 31, 2021, it held $3.58 billion in cash, cash equivalents and marketable investments against an $800.0 million outstanding balance under its $1.5 billion credit agreement. The company did not repurchase any equity in 2021 and has never paid cash dividends. Key near-term catalysts include the FDA review of the Tyvaso DPI new drug application, with a decision now anticipated by May 2022 after a major amendment extended the review. The filing also discusses pending patent litigation with Liquidia over Yutrepia, a generic-competition challenge from Sandoz and RareGen over Remodulin, and a 340B contract pharmacy dispute with HRSA.
Feb 24, 2022
2020
United Therapeutics Annual Report, Year Ended Dec 31, 2020
United Therapeutics Corporation (Nasdaq: UTHR) reported net product sales of $1.48 billion for 2020, compared with $1.45 billion in 2019, and net income of $514.8 million, compared with a net loss of $104.5 million in 2019. The 2019 loss reflected an $800.0 million upfront payment to Arena for ralinepag, which was expensed as acquired in-process R&D. Revenue growth was led by Tyvaso ($483.3 million, up from $415.6 million) and Orenitram ($293.1 million, up from $225.3 million), which offset a decline in Remodulin ($516.7 million, down from $587.0 million) and a steep drop in Adcirca ($67.3 million, down from $107.2 million) due to generic competition. Remodulin's non-U.S. sales fell to $64.3 million from $120.9 million amid generic competition in Europe. The company reported cash, cash equivalents and marketable investments of $2.98 billion at December 31, 2020, up from $2.25 billion, while $800.0 million was outstanding under its $1.5 billion Credit Agreement. Management stated it expects revenue growth in 2021, driven mainly by Tyvaso for PH-ILD if the pending sNDA is approved, continued Orenitram patient growth, and modest price increases, partly offset by Adcirca erosion. The filing also describes the COVID-19 impact on new patient starts in the second quarter of 2020, which had recovered to pre-pandemic levels by the end of the year, and it notes that the Remunity Pump launched commercially in February 2021. Pipeline timing has shifted in several programs. The Trevyent NDA resubmission is now expected to be delayed to 2022 after FDA feedback, and the Tyvaso DPI NDA is planned for April 2021 with a pediatric priority review voucher purchased for $105.0 million. The company also disclosed ongoing litigation with Sandoz/RareGen over subcutaneous Remodulin infusion devices and patent litigation with Liquidia over LIQ861, with a trial scheduled for March 2022.
Feb 24, 2021
2019
United Therapeutics Annual Report, Year Ended Dec 31, 2019
United Therapeutics Corporation (Nasdaq: UTHR) reported net product sales of $1.45 billion for 2019, down from $1.63 billion in 2018, as the company recorded a net loss of $104.5 million, compared with net income of $589.2 million in 2018. The decline was driven mainly by generic competition for Adcirca, whose net product sales fell to $107.2 million from $323.7 million. The loss was 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. Remodulin net product sales were $587.0 million, Tyvaso $415.6 million, Orenitram $225.3 million and Unituxin $113.7 million. Management anticipates revenue growth in 2020 compared with 2019, driven by treprostinil-based product growth and modest price increases, partly offset by Adcirca erosion and European generic launches. The pipeline is central to the outlook. The company said the INCREASE phase III study of Tyvaso in WHO Group 3 pulmonary hypertension associated with interstitial lung disease met its primary endpoint, with a 21-meter improvement in 6MWD versus placebo, and it expects to submit an efficacy supplement by mid-2020. The Trevyent NDA has a PDUFA date of April 27, 2020, but the company said the date could be extended or that it may receive a complete response letter. The Implantable System for Remodulin launch has been delayed to 2021, and the DISTINCT study of Unituxin in small cell lung cancer failed its primary endpoint. The Remunity system received FDA 510(k) clearance for pharmacy-fill and the company plans to launch it by July 2020. Balance sheet and liquidity remain solid. Cash, cash equivalents and marketable investments totaled $2.25 billion at December 31, 2019, against $850.0 million outstanding under the 2018 Credit Agreement. The company repurchased no shares in 2019 and has never paid cash dividends. The company also disclosed that the Adcirca license with Eli Lilly expires December 31, 2020, after which Adcirca sales will end unless the agreement is extended.
Feb 26, 2020
2018
United Therapeutics Annual Report, Year Ended Dec 31, 2018
United Therapeutics Corporation (UTHR) reported total revenues of $1,627.8 million for 2018, down from $1,725.3 million in 2017, with net income of $589.2 million versus $417.9 million the prior year. Net product sales were led by Remodulin ($599.0 million), Tyvaso ($415.2 million), Adcirca ($323.7 million), Orenitram ($205.1 million) and Unituxin ($84.8 million). The company attributes the 2019 outlook to lower revenues, largely because generic Adcirca launched in August 2018 and will be available for the full year, with potential additional pressure from generic Remodulin in Austria (launched January 2019) and expected U.S. and European generic launches in 2019. Management says it expects a return to revenue growth potentially as early as 2020, based on its pipeline and label expansions. The company's cash, cash equivalents and marketable investments rose to $1,858.5 million at year-end 2018 from $1,430.1 million, supported by $778.4 million of operating cash flow. Subsequent to year-end, United Therapeutics borrowed $800.0 million under its 2018 Credit Agreement to fund an upfront payment of $800.0 million to Arena Pharmaceuticals for ralinepag rights, and it had $1,050.0 million outstanding under that facility as of February 27, 2019. The filing also reports a February 2019 commercialization agreement with Medtronic for the Implantable System for Remodulin, an FDA-approved system with launch timing dependent on Medtronic satisfying remaining PMA conditions. Key risks highlighted include generic competition across Adcirca, Remodulin, Tyvaso and Orenitram, reliance on a small number of distributors (two specialty distributors accounted for 51 percent and 18 percent of 2018 revenues), a Corporate Integrity Agreement with the OIG following a $210.0 million DOJ settlement, and dependence on third parties such as Medtronic, MannKind and Lilly for manufacturing and supply.
Feb 27, 2019
2017
United Therapeutics Annual Report, Year Ended Dec 31, 2017
United Therapeutics Corporation's 2017 annual report describes a biotechnology company whose revenue depends on pulmonary arterial hypertension (PAH) products. Total revenues were $1,725.3 million in 2017, up from $1,598.8 million in 2016, with Remodulin ($670.9 million), Adcirca ($419.7 million), Tyvaso ($372.9 million), Orenitram ($185.8 million) and Unituxin ($76.0 million) as the commercial products. Net income fell to $417.9 million from $713.7 million, reflecting a $210.0 million settlement of a Department of Justice loss contingency, $71.0 million of provisional Tax Reform expense, and higher share-based compensation of $73.5 million. Diluted EPS was $9.31 versus $15.25 in 2016. The filing highlights significant revenue risk from generic competition. Sandoz may launch generic Remodulin in June 2018 and Teva, Par and Dr. Reddy's in December 2018. Adcirca faces generic entry after regulatory exclusivity expires in May 2018, which the company says will likely lead to a material adverse impact on Adcirca revenue. The company expects revenues to decrease in 2018 and anticipates a return to revenue growth beginning in 2019. Watson's ANDA challenge to Tyvaso is in litigation, with IPR proceedings instituted in January 2018, and the company settled with Actavis for Orenitram generic entry in June 2027. Cash, cash equivalents and marketable investments rose to $1,430.1 million from $1,053.1 million, aided by $250.0 million drawn on the $1.0 billion revolving credit facility to fund a share repurchase. Pipeline milestones include FREEDOM-EV results expected in the second half of 2018, resubmission of the NDA for the Implantable System for Remodulin in January 2018, and the Tyvaso-ILD INCREASE study. The company also entered a Corporate Integrity Agreement with the OIG for five years following the December 2017 DOJ settlement.
Feb 21, 2018
2016
United Therapeutics Annual Report, Year Ended Dec 31, 2016
United Therapeutics Corporation (UTHR) reported total revenues of $1,598.8 million for 2016, up from $1,465.8 million in 2015, with net income of $713.7 million, or $15.25 per diluted share, compared with $651.6 million in 2015. Operating income rose to $1,061.7 million from $699.0 million. Net product sales are concentrated in its PAH franchise: Remodulin ($602.3 million), Tyvaso ($404.6 million), Adcirca ($372.2 million), and Orenitram ($157.2 million), with Unituxin ($62.5 million) as its oncology product. Tyvaso sales declined to $404.6 million from $470.1 million, which the company attributes to the availability of oral prostacyclin-class therapies. The filing highlights several sources of future revenue pressure. Generic Adcirca is expected after the U.S. patent expires in November 2017, and the company has settled patent litigation with Sandoz, Teva and Par permitting generic Remodulin launches in June 2018 (Sandoz) and December 2018 (Teva and Par). Litigation continues with Watson over a generic Tyvaso and with Actavis over generic Orenitram, and SteadyMed's inter partes review of a treprostinil patent is awaiting a final PTAB decision expected by April 2017. Uptravi, an oral IP prostacyclin receptor agonist, competes directly with Orenitram. On the balance sheet, cash, cash equivalents and marketable investments totaled $1,053.1 million at year-end, and the company repurchased $500.0 million of common stock during 2016. Cash provided by operating activities was $643.6 million. The company had no borrowings under its $1.0 billion unsecured revolving credit facility at December 31, 2016. The filing also discloses a Department of Justice subpoena, received in May 2016, concerning support for 501(c)(3) patient assistance organizations, to which the company is cooperating.
Feb 22, 2017
2015
United Therapeutics Annual Report, Year Ended Dec 31, 2015
United Therapeutics Corporation's 2015 Annual Report (Form 10-K, filed February 25, 2016) reports total revenues of $1,465,761 thousand ($1.47 billion) for 2015, up from $1,288,519 thousand in 2014, and net income of $651,639 thousand, compared with $340,074 thousand in 2014. Net product sales are led by Remodulin ($572.8 million, 39% of total revenues), Tyvaso ($470.1 million, 32%), Adcirca ($278.8 million, 19%), Orenitram ($118.4 million, 8%) and Unituxin ($20.4 million, first full quarter of U.S. sales in Q3 2015). The company relies heavily on its PAH franchise, and substantially all revenues come from Remodulin, Tyvaso, Orenitram and Adcirca. The filing highlights several generic and patent risks. Sandoz and Teva may launch generic Remodulin in June 2018 and December 2018, respectively, under settlement agreements. Adcirca's U.S. patent expires in November 2017. Generic challenges are pending against Tyvaso (Watson) and Orenitram (Actavis, notice received February 2016), and SteadyMed has petitioned for inter partes review of a treprostinil patent. Management also cites the FDA review of the Remodulin Implantable System (with a 2016 FDA action expected) and the Medtronic consent decree as sources of uncertainty. Capital allocation was active in 2015. The company sold a Rare Pediatric Priority Review Voucher for $350.0 million, repurchased $394.5 million of stock under its 2014 program, and settled $133.2 million of convertible notes. Cash, cash equivalents and marketable investments were $991.8 million at year-end. In January 2016 it entered a $1.0 billion unsecured revolving credit facility and authorized a new $500.0 million repurchase program for 2016.
Feb 25, 2016
2014
United Therapeutics Annual Report, Year Ended Dec 31, 2014
United Therapeutics Corporation's 10-K for fiscal 2014 reports total revenues of $1,288.5 million, up 15.4% from $1,117.0 million in 2013, with net income of $340.1 million, or $6.28 per diluted share, versus $174.6 million in 2013. Remodulin contributed $553.7 million, Tyvaso $463.1 million, Adcirca $221.5 million and Orenitram $41.3 million, the latter in its first year of sales following its December 2013 FDA approval. Operating income rose to $538.8 million from $292.5 million, largely because share-based compensation expense fell to $190.1 million from $320.8 million as the stock price rose less sharply in 2014 than in 2013. Cash, cash equivalents and marketable investments declined to $812.9 million from $1,136.7 million, reflecting $483.1 million of share repurchases, $111.3 million of early Convertible Notes conversions, and $144.1 million of cash-settled share tracking award exercises. The filing highlights substantial reliance on three treprostinil-based products and the Adcirca PDE-5 inhibitor, which together comprise substantially all revenue. Patent exposure is significant: Sandoz and Teva have filed ANDAs seeking to market generic Remodulin, and in August 2014 the District of New Jersey court ruled that U.S. Patent No. 6,765,117 is valid and enforceable, enjoining Sandoz until its October 2017 expiration, an order Sandoz has appealed. The filing also discloses a December 2013 subpoena from the Office of Inspector General of the Department of Health and Human Services relating to marketing practices for Remodulin, Tyvaso and Adcirca, which the company is cooperating with and whose outcome it cannot predict. Pipeline milestones include a Remodulin Implantable System PMA submitted by Medtronic to the FDA in December 2014, with a new NDA submitted in January 2015, and an FDA BLA accepted in June 2014 for the ch14.18 antibody for neuroblastoma. The company also reported that Chief Financial Officer John Ferrari will retire effective March 13, 2015, succeeded by James Edgemond.
Feb 24, 2015
2013
United Therapeutics Annual Report, Year Ended Dec 31, 2013
United Therapeutics Corporation's 10-K for fiscal 2013 reports total revenues of $1,116,984 thousand ($1.12 billion), up from $916,076 thousand in 2012, with net income of $174,560 thousand compared with $304,442 thousand in 2012. Net product sales are driven by Remodulin ($491.2 million, 44 percent of net revenues), Tyvaso ($438.8 million, 39 percent) and Adcirca ($177.0 million, 16 percent). Operating income fell to $292,499 thousand from $421,646 thousand, largely because share-based compensation rose sharply: the Share Tracking Award plan liability increased to $288.0 million as the stock appreciated 112 percent during 2013, and research and development expense rose to $299.3 million from $173.4 million, with share-based compensation the main driver. The company's pipeline and regulatory calendar is central to the outlook. The FDA approved Orenitram (extended-release oral treprostinil) in December 2013, with a commercial launch expected in mid-2014. A Biologics License Application for the Ch14.18 antibody is planned for the first half of 2014 after a Marketing Authorization Application was accepted by the EMA in December 2013. Medtronic completed the DelIVery trial of its implantable pump system for Remodulin, and a Japan marketing application for Remodulin was filed in the third quarter of 2013. Key risks include Sandoz's Paragraph IV ANDA filings against Remodulin, which the company is contesting in litigation in the U.S. District Court for the District of New Jersey, and a December 2013 subpoena from the HHS Office of Inspector General reflecting a civil investigation by the Department of Justice into marketing practices for Remodulin, Tyvaso and Adcirca. The 2016 Convertible Notes became convertible at holders' election and were reclassified to current liabilities, and the Remodulin patent expiring in October 2014 is set to lapse, which the filing expects to increase gross margins on those products.
Feb 25, 2014
2012
United Therapeutics Annual Report, Year Ended Dec 31, 2012
United Therapeutics Corporation's 2012 Form 10-K reports total revenues of $916.1 million for 2012, up from $743.2 million in 2011, with net income of $304.4 million ($5.71 diluted EPS) compared with $217.9 million in 2011. Remodulin contributed $458.0 million (50% of net revenues), Tyvaso $325.6 million (36%) and Adcirca $122.5 million (13%). Revenue growth was driven by continued growth in the number of patients prescribed the company's PAH products, with Tyvaso and Adcirca growing fastest. The filing highlights a significant regulatory setback: the FDA issued a complete response letter in October 2012 declining to approve the NDA for oral treprostinil. The company resubmitted in January 2013, with a targeted FDA response date of March 31, 2013, and the company now aims for FDA approval before the end of 2016. Additionally, Sandoz Inc. filed an ANDA seeking to market generic versions of Remodulin, and United Therapeutics has sued Sandoz in the U.S. District Court for the District of New Jersey. The company's Remodulin patent covering PAH treatment expires in October 2014, and other key patents run to 2017 and 2029. The balance sheet remained solid, with cash and marketable investments of $784.9 million, a $188.0 million share repurchase program completed during 2012, and a new $420.0 million repurchase authorization announced in February 2013. Debt totaled $276.3 million, including $250.0 million of 1.0% convertible senior notes due 2016.
Feb 26, 2013
2011
United Therapeutics Annual Report, Year Ended Dec 31, 2011
United Therapeutics Corporation's annual report for fiscal 2011 shows revenues rising to $743.2 million in 2011 from $592.9 million in 2010, a 25.3% increase, with operating income of $317.8 million versus $171.3 million and net income of $217.9 million versus $105.9 million. Growth was driven by Remodulin ($430.1 million, up 6.6%), Tyvaso ($240.4 million, up 58.4%) and Adcirca ($70.6 million, up 94.4%). Net income also benefited from lower share-based compensation expense tied to the decline in the share price under the Share Tracking Award Plans, which reduced operating expenses substantially compared with 2010. The company's pipeline and regulatory position carry significant uncertainty. The NDA for oral treprostinil was submitted in December 2011 and accepted for a standard 10-month review, but the FREEDOM-C and FREEDOM-C2 trials did not reach statistical significance, which the company acknowledges may limit commercial potential. On February 3, 2012, Sandoz filed a Paragraph IV ANDA challenge to the 10 mg/mL strength of Remodulin, and the company said it intends to vigorously enforce three listed patents. Beraprost-MR failed a phase II trial in November 2011, and the company recorded a $46.3 million charge tied to a royalty buy-down with Toray. Balance sheet activity included repayment of $250.0 million in 2011 convertible notes, issuance of $250.0 million of 1.0% convertible notes due 2016, and an accelerated share repurchase of $212.0 million under a $300.0 million program. Cash and marketable investments were $747.4 million at year end, and the company reported $266.8 million of total debt.
Feb 28, 2012
2010
United Therapeutics Annual Report, Year Ended Dec 31, 2010
United Therapeutics Corporation is a biotechnology company focused on developing and commercializing products for chronic and life-threatening conditions. Its lead product, Remodulin (treprostinil), generated $403.6 million, or 67% of 2010 net revenues. Tyvaso, approved by the FDA in July 2009 and launched in September 2009, contributed $151.8 million (25% of revenues), and Adcirca contributed $36.3 million (6%). Total revenues for 2010 were $603.8 million, up from $369.8 million in 2009, and the company reported 2010 net income of $105.9 million, or $1.78 per diluted share, compared with a 2009 net income of $19.5 million. Cash, cash equivalents and marketable investments reached $759.9 million at December 31, 2010, versus $378.1 million a year earlier. The company also obtained a $70.0 million mortgage loan in December 2010 and has $250.0 million of Convertible Senior Notes maturing in October 2011, which it states it has the liquidity to repay. Key pipeline items include the FREEDOM-M and FREEDOM-C2 Phase III trials of oral treprostinil, with preliminary FREEDOM-M results expected in June 2011 and no NDA anticipated before 2012. The company also agreed on February 7, 2011 to sell its telemedicine subsidiary Medicomp for $14.9 million in aggregate consideration, with closing expected in March or April 2011. Investors should note the filing's stated dependence on Remodulin and Tyvaso, reliance on third-party manufacturers and distributors, a single distributor accounting for 64% of 2010 consolidated revenues, the pending Lilly sale of approximately 3.1 million shares, and exposure to pricing and reimbursement pressures under the Patient Protection and Affordable Care Act.
Feb 24, 2011
2009
United Therapeutics Annual Report, Year Ended Dec 31, 2009
United Therapeutics Corporation's 2009 Form 10-K reports total revenues of $369.8 million for 2009, up from $281.5 million in 2008, with net income of $19.5 million ($0.35 diluted EPS) compared with a net loss of $49.3 million in 2008. The 2008 loss reflected a $150.0 million one-time upfront fee paid to Eli Lilly and Company for commercial rights to Adcirca, which was expensed as research and development. Remodulin remained the core product, generating $331.6 million, or 90% of 2009 net revenues. Tyvaso, approved by the FDA in July 2009 and launched in September 2009, contributed $20.3 million, and Adcirca, approved in May 2009, contributed $5.8 million. The company highlighted several regulatory and pipeline developments. The European Medicines Agency application for Tyvaso was withdrawn in February 2010 after findings of non-compliance with good clinical practice at two clinical sites. The oral treprostinil program was set back when the FREEDOM-C Phase III trial missed statistical significance in November 2008; the company added a lower-strength tablet to FREEDOM-M and started FREEDOM-C2, and does not anticipate filing an NDA before 2012. The company also announced a 9.6% Remodulin list price increase effective March 25, 2010. Balance sheet items require attention. The $250.0 million 0.50% Convertible Senior Notes due October 2011 became convertible at holders' election at year-end 2009 and were reclassified to current liabilities, which turned working capital negative at $5.7 million. Management expects most holders to keep the notes until maturity and cites approximately $214.6 million of working capital available for operating needs. Cash, cash equivalents and marketable investments totaled $378.1 million, and about $36.2 million par value of auction-rate securities remain illiquid, partly protected by a put option exercisable between June 30, 2010 and July 2, 2012.
Feb 26, 2010
2008
United Therapeutics Annual Report, Year Ended Dec 31, 2008
United Therapeutics Corporation's 2008 Form 10-K reports a biotechnology company focused on cardiovascular, infectious disease and cancer products, with Remodulin (treprostinil sodium) as its lead product and substantially all revenue. Revenues rose to $281.5 million in 2008 from $210.9 million in 2007, and Remodulin accounted for $269.7 million, or 96% of net revenues. The company reported a net loss of $42.8 million, or $1.87 per share, compared with net income of $19.9 million in 2007. The loss was driven primarily by a $150.0 million one-time upfront payment to Eli Lilly for rights to tadalafil for pulmonary hypertension, which was expensed as research and development. The pipeline includes an inhaled treprostinil NDA under FDA review and an MAA under EMEA review, with the company expecting to begin selling inhaled treprostinil in 2009 if approval is obtained. The oral treprostinil FREEDOM-C Phase III trial did not meet statistical significance on its primary endpoint, and the company is redesigning the FREEDOM-M trial and planning FREEDOM-C2. Management does not anticipate filing an NDA for oral treprostinil before 2012. The OvaRex ovarian cancer program failed its pivotal trials and was terminated. Balance sheet items include cash, cash equivalents and marketable investments of $336.3 million, $250.0 million of 0.50% Convertible Senior Notes due October 2011 (classified as non-current at year-end), and stockholders' equity of $507.7 million. Operating cash flow was negative $49.2 million, and the company had $36.8 million (par value) of illiquid auction-rate securities, subject to a Rights Offer put option exercisable from June 30, 2010.
Feb 26, 2009
2007
United Therapeutics Annual Report, Year Ended Dec 31, 2007
United Therapeutics Corporation's annual report for fiscal 2007 shows revenue of $210.9 million, up from $159.6 million in 2006, driven mainly by growth in Remodulin sales to distributors as more patients were treated with the drug. Remodulin accounted for 95% of total 2007 revenues, and net income fell to $19.9 million from $73.97 million in 2006, with diluted EPS of $0.88 versus $3.06. Operating income dropped to $6.3 million from $29.0 million as selling, general and administrative expenses rose to $99.0 million, including $36.4 million of stock option expense, and R&D rose to $83.4 million. The pipeline had mixed results. The TRIUMPH-1 Phase III trial of inhaled treprostinil showed a median six-minute walk improvement of approximately 20 meters versus placebo, and the company plans to file a New Drug Application by mid-2008. The IMPACT I and II Phase III trials of OvaRex failed to reach statistical significance, and the company is ceasing development of that antibody platform. The two Phase III FREEDOM trials of oral treprostinil are ongoing, with the FREEDOM-C interim data expected to be unblinded in late 2008. Balance sheet items warrant attention. The $250.0 million 0.50% Convertible Senior Notes due 2011 are now classified as current liabilities because holders can convert them, which reduced working capital to $79.7 million from $258.1 million. The company also reported $299.3 million in cash, cash equivalents and marketable investments, plus $44.2 million of restricted amounts. Its Silver Spring laboratory is financed through an off-balance-sheet synthetic lease, and new construction projects in North Carolina and Maryland are expected to cost approximately $107.1 million and $106.1 million, respectively.
Feb 29, 2008
2006
United Therapeutics Annual Report, Year Ended Dec 31, 2006
United Therapeutics Corporation (UTHR) reported that its lead product, Remodulin (treprostinil), drove 2006 results. Total revenues were $159.6 million in 2006, up from $115.9 million in 2005, with Remodulin sales of $152.5 million, or about 96% of total revenues. Net income was $73.97 million, or $3.06 per diluted share, which includes a $34.1 million income tax benefit from a roughly $45.7 million reduction in the deferred tax asset valuation allowance. The company reported an accumulated deficit of approximately $41.4 million at December 31, 2006, and said it had been profitable in every quarter since March 31, 2004. The company issued $250.0 million of 0.50% Convertible Senior Notes due 2011 in October 2006, with net proceeds of about $242.0 million. It used about $112.4 million of those proceeds to repurchase about 1.8 million shares, paid about $35.4 million for convertible note hedge and warrant transactions, and began a broader repurchase program of up to 4.0 million shares. Cash, cash equivalents and marketable investments were $303.2 million at year-end 2006, and stockholders' equity fell to $204.6 million because of share repurchases. Key pipeline and risk items include the TRIUMPH-1 inhaled treprostinil (Viveta) Phase III trial, the FREEDOM-C and FREEDOM-M oral treprostinil trials, two Phase III OvaRex ovarian cancer trials with 367 patients enrolled, and the UT-231B hepatitis C program, which did not demonstrate efficacy. The filing also flags a February 2007 CDC inquiry into bloodstream infections among patients on intravenous Remodulin and the Pulmonary Hypertension Association's guidance in response, along with pending distributor consolidation in the United States and the expected generic availability of Flolan from May 2007.
Feb 28, 2007
2005
United Therapeutics Annual Report, Year Ended Dec 31, 2005
United Therapeutics Corporation (filed under this name; NASDAQ: UTHR) is a biotechnology company focused on cardiovascular, cancer and infectious disease products. Its lead product, Remodulin (treprostinil), is approved by the FDA for pulmonary arterial hypertension, and it accounted for 94 percent of total revenues in 2005. Revenues rose to $115.9 million in 2005 from $73.6 million in 2004, and the company reported net income of $65.0 million, or $2.58 per diluted share, which included a $17.5 million income tax benefit from a $19.7 million reduction in its deferred tax valuation allowance. Income from operations was $42.9 million, compared with $13.2 million in 2004. The company had an accumulated deficit of $115.3 million at December 31, 2005, and cash, cash equivalents and marketable investments of $191.0 million. The most significant risk for investors is Remodulin's FDA approval status. Approval is conditioned on completing a post-marketing Phase IV study, which did not meet its enrollment deadlines. The company submitted interim results from 21 patients, which it reports as positive (p=0.0006), and enrollment is suspended pending FDA review. The FDA could extend the trial or institute a public hearing to withdraw approval. Other pipeline programs are earlier stage: the OvaRex ovarian cancer Phase III trials are ongoing, the lead glycobiology antiviral UT-231B did not show efficacy against hepatitis C, and the inhaled TRIUMPH trial is about one-half enrolled. The company also discontinued its HeartBar product line in January 2006 and expects a roughly $2.0 million non-cash impairment charge in the first quarter of 2006.
Feb 27, 2006
2004
United Therapeutics Annual Report, Year Ended Dec 31, 2004
United Therapeutics Corporation (UTHR), a Silver Spring, Maryland biotechnology company, filed its 10-K for fiscal 2004 on February 25, 2005. The company reported 2004 revenues of $73.6 million, up from $53.3 million in 2003, and net income of $15.4 million, compared with a net loss of $10.0 million in 2003. Growth was driven primarily by Remodulin, which generated $66.1 million in 2004 revenue and accounted for approximately 90% of total revenues. Net income was $15.4 million, but the company still reported an accumulated deficit of $180.3 million at December 31, 2004. The filing's central risk is the FDA-required Phase IV post-marketing study for Remodulin. Only 15 of the 39 required patients had been enrolled, and the company stated it was not enrolling within the FDA's timeframe, leaving it at risk of a public hearing to withdraw marketing approval. The company has proposed that the FDA evaluate results based on enrollment through September 15, 2005, and the FDA was reviewing that proposal. Intravenous Remodulin was approved in November 2004, subject to the same Phase IV condition. The pipeline showed setbacks: UT-231B did not demonstrate efficacy against hepatitis C in patients who previously failed conventional treatment, and critical limb ischemia development was ended after difficulty recruiting patients. Balance sheet strength improved modestly. Cash, cash equivalents and marketable investments totaled $139.1 million at December 31, 2004, up from $117.3 million, and stockholders' equity rose to $191.6 million. The company said its resources would be adequate to fund operations through 2007. It also entered a synthetic operating lease with Wachovia to fund a laboratory facility of up to $32.0 million, with a guaranteed minimum residual value of approximately $27.5 million, and filed a shelf registration for up to five million shares of common stock.
Feb 25, 2005
2003
United Therapeutics Annual Report, Year Ended Dec 31, 2003
United Therapeutics Corporation, a Delaware biotechnology company based in Silver Spring, Maryland, filed its 10-K for fiscal 2003 focused on developing therapeutics in cardiovascular medicine, infectious disease and oncology. Its lead product, Remodulin, was approved by the FDA on May 21, 2002 for pulmonary arterial hypertension, and Remodulin sales accounted for approximately 85% of 2003 revenues. Total revenues rose to $53.3 million in 2003 from $30.1 million in 2002, while the net loss narrowed to $10.0 million from $23.7 million. The company reported an accumulated deficit of $195.8 million at December 31, 2003, and management expects to keep incurring losses and cannot assure future profitability. The company's liquidity remained substantial but declined, with cash, cash equivalents and marketable investments of $117.3 million at year-end 2003, down from $132.7 million. Management believes total revenues and existing capital resources will fund operations through 2006. Key open items include the Phase IV post-marketing study of Remodulin, which must be completed by December 2005 and on which continued FDA approval is conditioned, and a pending supplemental NDA for intravenous Remodulin filed in January 2004. Phase III trials of OvaRex for ovarian cancer are ongoing. Investors should weigh the concentration of revenue in a single product, dependence on third-party distributors and suppliers, and the risks inherent in clinical and regulatory outcomes. The filing also discloses that the company's directors and named executive officers beneficially own approximately 13% of outstanding common stock.
Mar 12, 2004
2002
United Therapeutics Annual Report, Year Ended Dec 31, 2002
United Therapeutics Corporation (Nasdaq: UTHR), a biotechnology company focused on cardiovascular, infectious and oncological diseases, reported its 10-K for the fiscal year ended December 31, 2002. The most important development was FDA approval of Remodulin (treprostinil sodium) Injection on May 21, 2002, for pulmonary arterial hypertension in NYHA class II-IV patients. Revenues rose to $30.1 million in 2002 from $5.7 million in 2001, driven primarily by approximately $21.2 million of Remodulin sales, while the net loss narrowed to $23.7 million from $37.3 million. Continued FDA approval is conditioned on completion and outcome of a 100-patient Phase IV study, of which four patients had been enrolled as of March 2003. The balance sheet shows cash, cash equivalents and marketable investments of $132.7 million at December 31, 2002, down from $172.3 million, with an accumulated deficit of $185.8 million. Management states that net cash from Remodulin sales together with existing capital resources is expected to be adequate to fund operations through 2006, based on estimated average annual revenue of approximately $36 million from about 410 reimbursable patients. The company also disclosed that it began two Phase III trials of OvaRex in ovarian cancer in January 2003, and that the FTC is reviewing advertising claims for the HeartBar product line. The filing carries substantial risk factors, including dependence on continued Remodulin approval, reliance on third-party manufacturers and distributors, patent expirations (the Remodulin method patent expires in 2009), and the company's history of losses. Management expects to continue incurring net losses.
Mar 19, 2003
2001-A
United Therapeutics Annual Report (Amendment), Year Ended Dec 31, 2001
This Amendment No. 1 to United Therapeutics Corporation's Form 10-K for fiscal year 2001 was filed to supplement Items 7, 8 and 14 in response to SEC review of a Form S-3 registration statement. The amendment adds disclosures on R&D project status, product and service sales and their costs, the Synergy license amendments and write-down, purchase price allocations for Unither Pharma, Medicomp and Telemedical Procedures, accounting for Northern Therapeutics, and segment information. The company reported 2001 total revenues of $5.73 million, against a net loss of $37.29 million ($1.84 per share), compared with a net loss of $75.61 million in 2000. Remodulin was deemed approvable by the FDA in February 2002 and was approved in May 2002 for pulmonary arterial hypertension in NYHA Class II-IV patients, subject to a required Phase IV study. The balance sheet at December 31, 2001 showed cash, cash equivalents and marketable investments of $172.3 million, down from $215.4 million a year earlier, and total stockholders' equity of $196.4 million. The company stated that existing capital resources are expected to be adequate to fund operations through 2004. Its accumulated deficit reached $162.2 million, and it expects to keep incurring net losses. Net cash used in operating activities was $38.9 million in 2001. The filing also flags uncertainty around the timing of Remodulin revenue, noting that prior revenue projections will be adversely affected by the delay in commercial launch. It also states that the cost of completing the major R&D projects is not estimable, and that the research programs in Remodulin for critical limb ischemia and glycobiology antivirals depend on clinical and regulatory outcomes that remain uncertain.
Oct 17, 2002
2000
United Therapeutics Annual Report, Year Ended Dec 31, 2000
United Therapeutics Corporation's Form 10-K for the fiscal year ended December 31, 2000 reports a biotechnology company focused on cardiovascular, inflammatory and infectious diseases, with no pharmaceutical product revenues to date. Total revenues were $2.05 million in 2000, while net loss was $75.6 million ($3.93 per share), up from $33.5 million in 1999. Research and development expenses rose to $70.2 million, including $19.8 million in beraprost licensing fees and $16.9 million of acquired in-process R&D tied to the Cooke Pharma and Medicomp acquisitions. The accumulated deficit reached $124.9 million at year-end. The company's lead product, Remodulin, for pulmonary hypertension has an NDA filed October 16, 2000, with a six-month Priority Review granted by the FDA. The filing also notes a Marketing Authorization Application submitted in France on February 2, 2001, and a Phase III pivotal study completed in March 2000 involving 470 patients. Beraprost is in Phase III programs for early-stage peripheral vascular disease and pulmonary hypertension. The company also expanded into arginine-based medical food (HeartBar) and telemedicine (Medicomp) in December 2000. At December 31, 2000, cash, cash equivalents and short-term investments totaled $215.4 million, against total stockholders' equity of $234.7 million. Two private placements in 2000 raised net proceeds of approximately $74.8 million and $134.3 million. Management expects existing capital resources to fund operations through 2004, and expects approximately $14.0 million in cash to be used in 2001 under clinical and research contracts.
Mar 30, 2001
1999
United Therapeutics Annual Report, Year Ended Dec 31, 1999
United Therapeutics Corporation (filed as United Therapeutics Corporation, Nasdaq: UTHR) reported in its Form 10-K for the fiscal year ended December 31, 1999 that it develops pharmaceuticals to treat vascular diseases, including pulmonary hypertension and peripheral vascular disease, and has not yet generated product revenues. Its lead product, Uniprost, is in two pivotal Phase III trials for advanced pulmonary hypertension, with enrollment of 224 and 235 patients completed. The company reported a net loss of $33.5 million for 1999 (or $2.51 per share) on total revenues of $436,495, and an accumulated deficit of $49.3 million at year-end. The filing states that all of the company's products remain in clinical trials. The balance sheet strengthened during the year. Cash, cash equivalents and short-term investments totaled $51.6 million at December 31, 1999, and total assets were $59.9 million. Stockholders' equity was $53.6 million. The company completed its initial public offering in June 1999 at $12.00 per share, with net proceeds of approximately $48.9 million, and sold over-allotment shares for about $7.5 million. In January 2000, it closed a private placement of 2.5 million shares at $32 per share, with net proceeds of about $75.0 million. The filing states that existing capital resources are expected to fund operations through 2002. The company's pipeline also includes beraprost (Phase III for early-stage peripheral vascular disease and early-stage pulmonary hypertension), UT-77 (Phase II for chronic obstructive pulmonary disease), and Ketotop (preparing Phase III for osteoarthritis). The company acquired SynQuest, Inc., its Uniprost manufacturer, in October 1999. Subsequent events in March 2000 include an agreement with Synergy Pharmaceuticals for anti-viral patent rights, with milestone payments of up to $22.2 million per approved product. The filing also notes 63 employees as of March 15, 2000 and that the company is not a party to any legal proceedings.
Mar 22, 2000