United Therapeutics(UTHR)
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United Therapeutics(UTHR) - 2022 Q2 - Quarterly Report
2022-08-02 16:00
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2022 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (301) 608-9292 (Registrant's Telephone Number, Including Area Code) (Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of exchange ...
United Therapeutics(UTHR) - 2022 Q1 - Earnings Call Transcript
2022-05-04 16:06
United Therapeutics Corporation (NASDAQ:UTHR) Q1 2022 Results Conference Call May 4, 2022 9:00 AM ET Company Participants Dewey Steadman - Head, IR Martine Rothblatt - Chairperson, CEO Michael Benkowitz - President, COO Leigh Peterson - SVP, Product Development Patrick Poisson - EVP, Technical Operations Conference Call Participants Andreas Argyrides - Wedbush Securities Eun Yang – Jefferies Jessica Fye – JPMorgan Joseph Thome - Cowen & Company Operator Good morning, and welcome to the United Therapeutics C ...
United Therapeutics(UTHR) - 2022 Q1 - Quarterly Report
2022-05-03 16:00
Product Sales and Revenue Growth - The company reported net product sales from five commercial products, with price increases typically in the single-digit percentages per year, except for Adcirca, which is priced solely by Eli Lilly[105]. - The company anticipates growth in the number of Tyvaso patients due to the expanded label, contributing to future revenue growth[102]. - Total revenues for the three months ended March 31, 2022, were $461.9 million, an increase of 22% compared to $379.1 million for the same period in 2021[143]. - Net product sales of Tyvaso increased by 40% to $172.0 million for the three months ended March 31, 2022, up from $123.0 million in the same period in 2021[143]. - Orenitram net product sales increased by 14% to $82.8 million for the three months ended March 31, 2022, compared to $72.4 million in the same period in 2021[143]. Product Development and Approvals - Tyvaso, an inhaled formulation, was approved by the FDA for pulmonary hypertension associated with interstitial lung disease (PH-ILD), expanding its patient base[106]. - The Tyvaso DPI, a dry powder formulation of inhaled treprostinil, is under review by the FDA, with a decision anticipated in May 2022[123]. - The company is conducting multiple phase 3 studies for its product Tyvaso, targeting conditions such as PH-COPD and IPF, with an estimated 100,000 patients affected by PH-COPD in the U.S.[128]. - Ralinepag, an oral prostacyclin receptor agonist, is undergoing two phase 3 studies to evaluate its efficacy in PAH patients[134]. - The Aurora-GT gene therapy study is being conducted in Canada, with plans to seek FDA approval if successful[135]. Litigation and Market Competition - The company has settled litigation allowing generic versions of Tyvaso and Orenitram to enter the market in January 2026 and June 2027, respectively, which may impact future sales[109]. - The company is engaged in patent litigation with Liquidia concerning Tyvaso, which could affect market competition if Liquidia's product is approved[110]. - Remodulin sales have seen minimal erosion from generic competition in the U.S. as of March 31, 2022, despite ongoing litigation with Sandoz and RareGen[107]. - The company intends to vigorously enforce its intellectual property rights, although challenges from generic competitors may arise[115]. Research and Development - The company has incurred significant research and development expenses, focusing on expanding its pipeline programs, which are expected to continue driving costs[118]. - The company is developing a new prodrug, RemoPro, intended to minimize site pain associated with subcutaneous delivery of treprostinil[126]. - The Remunity Pump, launched in February 2021, is designed for subcutaneous delivery of treprostinil, aiming to reduce patient manipulation during use[124]. - The company is engaged in research to address the shortage of transplantable organs through technologies like 3-D organ bioprinting and xenotransplantation[136]. - The company is focused on organ manufacturing as a complementary solution for diseases that are currently incurable through traditional therapies[138]. Financial Performance and Expenses - Research and development expenses decreased by 77% to $69.0 million for the three months ended March 31, 2022, compared to $303.7 million for the same period in 2021[151]. - General and administrative expenses increased to $81.3 million in Q1 2022, up 14% from $71.6 million in Q1 2021[153]. - Total selling, general, and administrative expenses decreased to $79.0 million in Q1 2022, down 33% from $117.2 million in Q1 2021[153]. - Share-based compensation expense showed a significant decrease, resulting in a benefit of $21.1 million in Q1 2022 compared to an expense of $40.1 million in Q1 2021, a change of 153%[156]. - Net cash provided by operating activities increased to $288.7 million in Q1 2022, a 221% increase from $89.8 million in Q1 2021[161]. Cash and Investments - Cash and cash equivalents decreased by 9% to $813.3 million as of March 31, 2022, from $894.8 million at the end of 2021[160]. - Marketable investments increased by 40% to $1,454.4 million in Q1 2022, compared to $1,035.9 million in Q4 2021[160]. - The company entered into a credit agreement in March 2022, providing unsecured revolving credit facilities of up to $2.0 billion, with an outstanding balance of $800.0 million as of March 31, 2022[166]. - Net cash used in investing activities increased significantly to $359.2 million in Q1 2022, compared to $6.3 million in Q1 2021[161]. - The company reported a $105.0 million purchase of a pediatric disease priority review voucher in Q1 2021, impacting cash flows[163]. Impact of COVID-19 - The company is closely monitoring the impact of COVID-19 on its operations, with no material changes reported since the 2021 Annual Report[103]. - The company expects to maintain adequate inventories of its commercial products through in-house and third-party manufacturing capabilities[102].
United Therapeutics(UTHR) - 2021 Q4 - Earnings Call Transcript
2022-02-27 15:14
United Therapeutics Corporation (NASDAQ:UTHR) Q4 2021 Earnings Conference Call February 24, 2022 9:00 AM ET Company Participants Dewey Steadman - Head of IR Martine Rothblatt - Founder, Chairman and CEO Michael Benkowitz - President and COO Conference Call Participants Joseph Thome - Cowen and Company Eun Yang - Jefferies LLC Jessica Fye - JPMorgan Andreas Argyrides - Wedbush Securities Inc. Operator Good morning, and welcome to the United Therapeutics Corporation Fourth Quarter and Full Year 2021 Earnings ...
United Therapeutics(UTHR) - 2021 Q4 - Annual Report
2022-02-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission file number 0-26301 Registrant's Telephone Number, Including Area Code Securities registered pursuant to Section 12(b) of the Act: Title of each cl ...
United Therapeutics(UTHR) - 2021 Q3 - Earnings Call Transcript
2021-11-03 18:49
United Therapeutics Corporation (NASDAQ:UTHR) Q3 2021 Earnings Conference Call November 3, 2021 9:00 AM ET Company Participants Dewey Steadman - Head, IR Martine Rothblatt - Chairperson and CEO Michael Benkowitz - President and COO Leigh Peterson - SVP, Product Development James Edgemond - CFO and Treasurer Conference Call Participants Joseph Thome - Cowen and Company Jessica Fye - JPMorgan Hartaj Singh - Oppenheimer Eun Yang - Jefferies Operator Good morning and welcome to the United Therapeutics Corporati ...
United Therapeutics(UTHR) - 2021 Q3 - Quarterly Report
2021-11-02 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission file number 0-26301 United Therapeutics Corporation (Exact Name of Registrant as Specified in Its Charter) Delaware 52-1984749 (State or Other Jurisdiction of (I.R.S. Employ ...
United Therapeutics(UTHR) - 2021 Q2 - Earnings Call Transcript
2021-08-04 17:12
United Therapeutics Corporation (NASDAQ:UTHR) Q2 2021 Earnings Conference Call August 4, 2021 9:00 AM ET Company Participants Dewey Steadman - Head, Investor Relations Martine Rothblatt - Chairperson and Chief Executive Officer Michael Benkowitz - President and Chief Operating Officer James Edgemond - Chief Financial Officer and Treasurer Leigh Peterson - Senior Vice President, Product Development Conference Call Participants Jessica Fye - JPMorgan Hartaj Singh - Oppenheimer & Company Joseph Thome - Cowen & ...
United Therapeutics(UTHR) - 2021 Q2 - Quarterly Report
2021-08-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q For the transition period from to Commission file number 0-26301 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. Title of each class Trading Symbol(s) Name of exchange on which registered Common Stock, par value $0.01 ...
United Therapeutics(UTHR) - 2021 Q1 - Earnings Call Transcript
2021-05-05 17:55
Financial Data and Key Metrics Changes - The company aims to increase the number of patients treated from over 8,000 to over 25,000 by 2025, a goal referred to as "25/25" [8][25] - The company expects to achieve approximately half of the required growth from WHO Group 1 pulmonary arterial hypertension and the other half from WHO Group 3 pulmonary hypertension [10][15] Business Line Data and Key Metrics Changes - The company anticipates gaining about 3,000 new patients each from Remodulin, Tyvaso, and Orenitram in the WHO Group 1 category [11][12][13] - The company is the only drug approved for the IPF market segment of patients with pulmonary hypertension, targeting to capture at least 9,000 patients from this group by 2025 [17] Market Data and Key Metrics Changes - There are approximately 50,000 patients being treated for pulmonary hypertension in the U.S., with about 45,000 treated with non-United Therapeutics drugs, indicating a significant market opportunity [14] - The company is focusing on educating new treaters and engaging patients to increase treatment uptake for Tyvaso in the ILD-PH segment [36] Company Strategy and Development Direction - The company is focused on expanding its patient base significantly by leveraging new product approvals and enhancing treatment options [25] - The company has several late-phase clinical trials underway, including studies for Tyvaso in COPD-associated pulmonary hypertension and ralinepag in Group 1 pulmonary hypertension [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the pulmonary hypertension market, citing a meaningful unmet need and the company's capabilities to address it [25][62] - The management believes that the goal of treating 25,000 patients by 2025 is realistic given the annual progression rates of existing patients [62] Other Important Information - The company is developing a once-daily formulation of Orenitram and less painful forms of Remodulin, expected to launch by 2025 [24] - The company is actively building relationships with new treaters and educating them about the benefits of Tyvaso [35] Q&A Session Summary Question: Strategy for Group 3 PH-ILD and patient targeting - Management indicated that they are building relationships with ILD treaters and have ongoing patient engagement efforts to educate patients about Tyvaso [30][36] Question: Commercialization plans for Tyvaso solution vs. Tyvaso DPI - Management stated that they expect a significant number of patients to transition to the dry powder inhaler, estimating a 70-30 split between dry powder and nebulizer usage [41] Question: Growth trajectory of Orenitram post-FREEDOM-EV study - Management noted that they are seeing an uptick in referrals and starts for Orenitram, with ongoing efforts to educate physicians on its value proposition [46][50] Question: TETON program and potential for DPI studies - Management confirmed that once approvals are received for Tyvaso, additional indications for DPI will follow, and they are studying patient preferences for delivery methods [57]