United Therapeutics Corporation (NASDAQ:UTHR) Q4 2020 Earnings Conference Call February 24, 2021 9:00 AM ET Company Participants Dewey Steadman - Head, IR Martine Rothblatt - Chairman and CEO Michael Benkowitz - President and COO Leigh Peterson - VP, Product Development James Edgemond - CFO and Treasurer Conference Call Participants Joseph Thome - Cowen and Company Liana Moussatos - Wedbush Eun Yang - Jefferies Jessica Fye - JPMorgan Martin Auster - Credit Suisse Hartaj Singh - Oppenheimer Terence Flynn - G ...

Table of Contents 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, 2020 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 United Therapeutics Corporation (Exact Name of Registrant as Specified in Its Charter) Delaware 52-1984749 (S ...

United Therapeutics Corporation (NASDAQ:UTHR) Q3 2020 Earnings Conference Call October 28, 2020 9:00 AM ET Corporate Participants Dewey Steadman - Head, Investor Relations Martine Rothblatt - Chairman & Chief Executive Officer Michael Benkowitz - President & Chief Operating Officer Leigh Peterson - Vice President, Product Development James Edgemond - Chief Financial Officer & Treasurer Conference Call Participants Hartaj Singh - Oppenheimer Eun Yang - Jefferies Martin Auster - Credit Suisse Joseph Thome - C ...

Part I. FINANCIAL INFORMATION [Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents the unaudited consolidated financial statements for the periods ended September 30, 2020, providing a comprehensive overview of the company's financial position, performance, and cash flows [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheets present the company's financial position as of September 30, 2020, highlighting changes in assets, liabilities, and equity compared to December 31, 2019 Consolidated Balance Sheet Highlights (in millions) | Metric | Sep 30, 2020 (Unaudited) | Dec 31, 2019 | | :--- | :--- | :--- | | **Total Current Assets** | $1,868.2 | $1,864.5 | | **Total Assets** | $4,411.2 | $3,913.4 | | **Total Current Liabilities** | $258.9 | $463.0 | | **Total Liabilities** | $1,128.1 | $1,133.0 | | **Total Stockholders' Equity** | $3,283.1 | $2,780.4 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The Consolidated Statements of Operations detail revenues, expenses, and profitability, showing a significant turnaround in net income for the nine months ended September 30, 2020 Statement of Operations Summary (in millions, except per share data) | Metric | Q3 2020 | Q3 2019 | Nine Months 2020 | Nine Months 2019 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $380.1 | $401.5 | $1,098.4 | $1,137.7 | | **Operating Income (Loss)** | $221.1 | $183.4 | $528.3 | $(251.1) | | **Net Income (Loss)** | $171.2 | $132.4 | $416.0 | $(157.1) | | **Diluted EPS** | $3.84 | $3.01 | $9.37 | $(3.59) | [Consolidated Statements of Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) This statement reports changes in equity from non-owner sources, indicating a substantial improvement in comprehensive income for the nine-month period ended September 30, 2020 Comprehensive Income (Loss) (in millions) | Period | 2020 | 2019 | | :--- | :--- | :--- | | **Three Months Ended Sep 30** | $168.8 | $133.3 | | **Nine Months Ended Sep 30** | $425.7 | $(153.3) | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%20Equity) These statements detail changes in the company's equity accounts, primarily driven by net income and share-based compensation for the nine months ended September 30, 2020 - Total stockholders' equity increased by **$502.7 million** during the first nine months of 2020, from **$2,780.4 million** to **$3,283.1 million**[15](index=15&type=chunk) - The increase was primarily driven by a net income of **$416.0 million** for the nine-month period[15](index=15&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This statement shows the sources and uses of cash, with net cash provided by operating activities significantly improving due to the absence of a large prior-year payment Cash Flow Summary (Nine Months Ended Sep 30, in millions) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | **Net Cash from Operating Activities** | $629.5 | $(309.1) | | **Net Cash used in Investing Activities** | $(674.7) | $(401.6) | | **Net Cash (used in) from Financing Activities** | $(23.0) | $761.2 | | **Net (Decrease) Increase in Cash** | $(68.2) | $50.5 | | **Cash and Cash Equivalents, End of Period** | $670.2 | $719.7 | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of the company's accounting policies and specific financial statement items, covering business operations, investments, debt, and legal proceedings - The company's main commercial products are Remodulin, Tyvaso, Orenitram, Unituxin, and Adcirca[22](index=22&type=chunk) - As of September 30, 2020, the company had an outstanding principal balance of **$800.0 million** under its unsecured revolving credit facility, all classified as non-current[47](index=47&type=chunk) - The company is involved in significant litigation, including an antitrust lawsuit with Sandoz regarding Remodulin and patent infringement litigation with Liquidia Technologies over its NDA for LIQ861, a potential competitor to Tyvaso[76](index=76&type=chunk)[80](index=80&type=chunk)[83](index=83&type=chunk) - In the first quarter of 2019, the company expensed an **$800.0 million** upfront payment to Arena Pharmaceuticals for an exclusive license to ralinepag[88](index=88&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, covering the impact of COVID-19, product performance, R&D pipeline, and liquidity [Impact of COVID-19 and Competition](index=25&type=section&id=Impact%20of%20COVID-19%20and%20Competition) Management discusses the ongoing business impact of the COVID-19 pandemic and significant competitive pressures from generic products, including those affecting Adcirca and Remodulin - The company is closely monitoring the impact of the COVID-19 pandemic, which creates considerable uncertainty for near-term revenue and product development[94](index=94&type=chunk) - Generic competition for Adcirca has had a material adverse impact on its net product sales, and the company expects increased returns of expired product beginning in 2021[101](index=101&type=chunk) - Generic versions of Remodulin have been launched in the U.S. and Europe, with European revenues coming under increasing pressure[98](index=98&type=chunk)[99](index=99&type=chunk) - The company is in patent litigation with Liquidia over its LIQ861 product, which has triggered a 30-month stay on FDA approval for LIQ861[101](index=101&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) The R&D section details a robust pipeline with near-term and medium-term programs, alongside a long-term focus on organ manufacturing technologies - The Phase 3 INCREASE study of Tyvaso for PH-ILD met its primary endpoint, and an sNDA was submitted to the FDA in June 2020, with a potential decision in April 2021[126](index=126&type=chunk)[127](index=127&type=chunk) - The launch of the Remunity Pump has been delayed due to COVID-19 related supply chain issues impacting partner DEKA[119](index=119&type=chunk) - The FDA issued a Complete Response Letter (CRL) for the Trevyent NDA in April 2020; the company plans to resubmit the NDA in 2021[124](index=124&type=chunk) - Long-term R&D is focused on organ manufacturing, with a goal to commence human clinical trials of xenotransplanted kidneys in the near term[139](index=139&type=chunk) [Results of Operations Analysis](index=36&type=section&id=Results%20of%20Operations%20Analysis) This sub-section provides a detailed analysis of financial performance, highlighting revenue declines due to generic competition and significant impacts on operating expenses from share-based compensation and a one-time R&D expense Revenues by Product (in millions) | Product | Q3 2020 | Q3 2019 | % Change | | :--- | :--- | :--- | :--- | | Remodulin | $124.5 | $168.3 | (26)% | | Tyvaso | $129.5 | $110.8 | 17% | | Orenitram | $74.7 | $62.0 | 20% | | Unituxin | $37.6 | $30.1 | 25% | | Adcirca | $13.8 | $30.3 | (54)% | | **Total Revenues** | **$380.1** | **$401.5** | **(5)%** | - The decrease in nine-month R&D expense from **$1,069.0 million** in 2019 to **$231.6 million** in 2020 was primarily due to a one-time **$800.0 million** upfront payment to Arena in 2019[153](index=153&type=chunk)[155](index=155&type=chunk) - Share-based compensation (benefit) expense showed significant volatility, recording a **$(12.5) million** benefit in Q3 2020 versus a **$23.9 million** expense in Q3 2019, mainly due to stock price changes affecting the STAP liability[158](index=158&type=chunk)[160](index=160&type=chunk) [Financial Condition, Liquidity, and Capital Resources](index=41&type=section&id=Financial%20Condition%2C%20Liquidity%2C%20and%20Capital%20Resources) The company believes its liquidity, supported by substantial cash and marketable investments, is sufficient to fund operations and future plans, with strong net cash from operations Liquidity Position (in millions) | Metric | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $670.2 | $738.4 | | Marketable investments | $2,137.8 | $1,515.0 | | **Total** | **$2,808.0** | **$2,253.4** | - Net cash provided by operating activities for the nine months ended Sep 30, 2020, was **$629.5 million**, compared to net cash used of **$(309.1) million** in the same period of 2019[168](index=168&type=chunk)[170](index=170&type=chunk) - The company has an outstanding balance of **$800.0 million** under its credit facility, which matures in 2024[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company's exposure to market risk, including investment portfolio and interest rate fluctuations, has not materially changed since December 31, 2019 - The company's exposure to market risk has not materially changed since December 31, 2019[175](index=175&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were effective as of September 30, 2020[176](index=176&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter[176](index=176&type=chunk) Part II. OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 12 for information on significant legal proceedings, including antitrust litigation and patent infringement lawsuits related to key products - The company is engaged in antitrust litigation with Sandoz Inc. regarding alleged anticompetitive conduct related to the launch of a generic version of Remodulin[76](index=76&type=chunk)[77](index=77&type=chunk) - The company has filed a lawsuit against Liquidia Technologies for infringement of three patents related to Tyvaso, following Liquidia's submission of an NDA for its dry powder treprostinil product, LIQ861[83](index=83&type=chunk)[84](index=84&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of significant risks that could adversely affect the company's business, categorized by product, legal compliance, intellectual property, and financial capacity [Risks Related to Our Products](index=44&type=section&id=Risks%20Related%20to%20Our%20Products) This subsection details risks inherent to the company's product portfolio, including reliance on key products, intense competition, clinical trial failures, manufacturing complexities, and COVID-19 disruptions - The company relies heavily on sales of Remodulin, Tyvaso, and Orenitram, and any substantial decrease in sales could materially impact operations[179](index=179&type=chunk) - The COVID-19 pandemic poses significant risks, including potential disruption of operations, delays in the development pipeline, and a decrease in revenues from existing products[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk) - The company's manufacturing strategy, which involves both in-house production and reliance on third-party sole manufacturers, exposes it to significant risks of supply interruption[186](index=186&type=chunk) [Risks Related to Legal Compliance](index=51&type=section&id=Risks%20Related%20to%20Legal%20Compliance) This subsection outlines risks associated with the complex legal and regulatory landscape, including compliance with drug approval and marketing laws, anti-kickback statutes, and healthcare reform pricing pressures - The business is subject to extensive laws and regulations in the U.S. and other countries, and failure to comply could prevent or delay product commercialization[209](index=209&type=chunk) - Marketing practices are restricted by laws such as the Federal Anti-Kickback Statute and the Federal False Claims Act, with violations carrying severe penalties[211](index=211&type=chunk)[212](index=212&type=chunk) - Government healthcare reform, particularly efforts to control drug pricing, could adversely affect revenue and results of operations[215](index=215&type=chunk)[217](index=217&type=chunk) [Risks Related to Our Intellectual Property and Data Privacy](index=53&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20and%20Data%20Privacy) This subsection discusses intellectual property and data security risks, including potential loss of license rights, patent challenges, infringement risks, and information technology breaches - The company's patents may not effectively deter competitors, and upon expiration, could lead to generic competition and revenue loss. Patents are currently being challenged by third parties like Liquidia[230](index=230&type=chunk)[232](index=232&type=chunk) - The company is dependent on information technology systems and is vulnerable to security breaches that could compromise confidential information and lead to legal liability[237](index=237&type=chunk) - The business depends on intellectual property licensed from third parties, and termination of these agreements could result in the loss of rights to key products[227](index=227&type=chunk) [Risks Related to Our Financing Capacity, Indebtedness, and Investments](index=57&type=section&id=Risks%20Related%20to%20Our%20Financing%20Capacity%2C%20Indebtedness%2C%20and%20Investments) This subsection covers financial risks, including the potential need for additional financing, ability to service debt, and market risks associated with its investment portfolio - The company may not be able to generate sufficient cash to service or repay its **$800.0 million** in debt, which could adversely affect its financial position[240](index=240&type=chunk) - The company's investment portfolio of corporate debt and equity securities is subject to market, interest, and credit risks that may reduce its value and impact earnings[243](index=243&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no sales of unregistered equity securities or repurchases of outstanding equity securities during the nine months ended September 30, 2020 - During the nine months ended September 30, 2020, the company did not repurchase any of its equity securities or sell any unregistered equity securities[251](index=251&type=chunk) [Exhibits](index=61&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, officer certifications, and financial statements in iXBRL format - The exhibits filed with the report include CEO and CFO certifications pursuant to Sarbanes-Oxley Act rules[253](index=253&type=chunk) - Financial statements and notes are provided in iXBRL format as part of the exhibits[253](index=253&type=chunk)

Business Overview - United Therapeutics focuses on developing novel, life-extending technologies for patients in oncology, lung disease, and organ manufacturing[8] - The company has multiple approved therapies and over 20 years of experience addressing unmet medical needs in pulmonary arterial hypertension (PAH) and neuroblastoma (NB)[9] - United Therapeutics aims to find a cure through balance and value creation[11] Financial Performance & Product Strategy - Treprostinil revenue remains stable despite generic competition[13] - United Therapeutics believes Remodulin revenues will continue to grow due to safety, supply chain reliability, patient support, a highly differentiated product platform, and limited switching in the PAH space[17, 18, 19] - The company aims to expand its reach to 25,000 patients on PH therapies, a 3x increase from the current 7,500 patients[31, 32] Pipeline Development - Key benefits of expanded Orenitram label include a 61% reduction in risk of disease progression, improvement in key prognostic measures, a 37% reduction in risk of death, and reduced PAH-associated healthcare costs relative to selexipag[36] - Tyvaso increased the six-minute-walk-distance (6MWD) by 21 meters versus placebo (p=00043) after 16 weeks of treatment in PH WHO Group 3 patients[43] - The company is developing a pump for every PAH patient, including an implantable system for Remodulin (ISR) and Remunity[48, 49] Organ Manufacturing - United Therapeutics aims to transform the marketplace to make more organs available for transplant through EVLP, XENO, Lung Lobes, and 3DAP technologies[61] - In organ manufacturing, 152 EVLP patients' lives have been saved, Xeno kidneys have supported life for >6 months in preclinical models, Lung Lobes have achieved 70% recellularization and 15% lung function, and 60% of lungs have been 3DAP printed[64]

United Therapeutics Corporation (NASDAQ:UTHR) Q2 2020 Earnings Conference Call July 29, 2020 9:00 AM ET Corporate Participants Dewey Steadman - Head, Investor Relations Martine Rothblatt - Chairman and Chief Operating Officer Mike Benkowitz - President and Chief Operating Officer Leigh Peterson - Vice President, Product Development Conference Call participants Hartaj Singh - Oppenheimer Eun Yang - Jefferies Martin Auster - Credit Suisse Liana Moussatos - Wedbush Securities Christopher Zopf - Cowen and Compa ...

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. For the quarterly period ended June 30, 2020 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 United Therapeutics Corporation (Exact Name of Registrant as Specified in Its Charter) | Delaware | | --- ...

Financial Performance & Strategy - United Therapeutics' treprostinil revenue remains stable despite generic competition[22] - The company believes Remodulin revenues will continue to grow due to safety, supply chain reliability, patient support, and a highly differentiated product platform[27, 28] Pulmonary Hypertension (PH) Market & Opportunities - United Therapeutics is targeting expansion in the PH market, including PH associated with Interstitial Lung Disease (ILD) and Chronic Obstructive Pulmonary Disease (COPD)[32] - The company estimates over 130,000 patients in the U S have PH ILD and ~100,000 have PH COPD[36] - United Therapeutics aims to reach 25,000 patients on PH therapies, a 3x increase from the current 7,500 patients[40, 41] Orenitram® Label Expansion Benefits - Expanded Orenitram® label shows a 61% reduction in the risk of disease progression[45] - Orenitram® is associated with a 37% reduction in the risk of death versus placebo at study closure[45] - PAH-related healthcare costs were 67% higher for selexipag patients than for Orenitram patients[45] Pipeline Development & Milestones - Tyvaso® INCREASE Phase III clinical trial in PH WHO Group 3 hit primary and all secondary endpoints, with sNDA planned mid-2020[49, 51] - Tyvaso increased six-minute-walk-distance (6MWD) by 21 meters versus placebo after 16 weeks of treatment (p=0 0043)[53] - Implantable System for Remodulin® is FDA cleared with U S launch targeted for July 2020[59, 87] Organ Manufacturing - United Therapeutics is developing organ manufacturing technologies, including EVLP, XENO kidneys, lung lobes, and 3DAP lungs[73] - EVLP has saved the lives of 137 patients[75] - 60% of lung 3DAP has been printed[75]

United Therapeutics Corporation (NASDAQ:UTHR) Q1 2020 Earnings Conference Call April 29, 2020 9:00 AM ET Company Participants Dewey Steadman - Head, IR Martine Rothblatt - Chairman & CEO Michael Benkowitz - President & COO Leigh Peterson - VP, Product Development James Edgemond - CFO & Treasurer Conference Call Participants Chris Shibutani - Cowen Eun Yang - Jefferies Hartaj Singh - Oppenheimer Jessica Fye - JPMorgan Liana Moussatos - Wedbush Securities Martin Auster - Credit Suisse Operator Good morning, a ...

Part I. Financial Information (Unaudited) [Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position and operations, reporting a significant turnaround to net income in Q1 2020 [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet reflects increased total assets and cash, alongside decreased liabilities primarily due to credit reclassification Consolidated Balance Sheet Highlights (in millions) | Account | March 31, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $875.2 | $738.4 | | Total current assets | $1,846.3 | $1,864.5 | | Total assets | $4,025.9 | $3,913.4 | | **Liabilities & Equity** | | | | Total current liabilities | $207.3 | $463.0 | | Line of credit (non-current) | $800.0 | $600.0 | | Total liabilities | $1,077.4 | $1,133.0 | | Total stockholders' equity | $2,948.5 | $2,780.4 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The statements of operations show a significant shift to net income in Q1 2020, primarily driven by a substantial decrease in R&D expenses compared to the prior year Consolidated Statements of Operations (in millions, except per share data) | Metric | Q1 2020 | Q1 2019 | | :--- | :--- | :--- | | Total revenues | $356.3 | $362.6 | | Research and development | $73.2 | $897.4 | | Total operating expenses | $189.6 | $1,018.5 | | Operating income (loss) | $166.7 | ($655.9) | | Net income (loss) | $137.7 | ($494.6) | | Diluted net income (loss) per share | $3.12 | ($11.32) | - The dramatic swing from a significant operating loss in Q1 2019 to operating income in Q1 2020 was driven by the **$800.0 million** upfront payment under the license agreement with Arena Pharmaceuticals, which was recorded as R&D expense in Q1 2019[68](index=68&type=chunk)[82](index=82&type=chunk)[166](index=166&type=chunk) [Consolidated Statements of Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) Comprehensive income for Q1 2020 significantly improved to **$148.4 million**, primarily due to the shift from net loss to net income and unrealized gains Consolidated Statements of Comprehensive Income (in millions) | Metric | Q1 2020 | Q1 2019 | | :--- | :--- | :--- | | Net income (loss) | $137.7 | ($494.6) | | Other comprehensive income, net of tax | $10.7 | $2.7 | | **Comprehensive income (loss)** | **$148.4** | **($491.9)** | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to **$2.95 billion** as of March 31, 2020, driven by net income and share-based compensation [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities was **$214.6 million** for Q1 2020, a significant improvement from the prior year's cash usage, primarily due to reduced R&D payments Consolidated Statements of Cash Flows Highlights (in millions) | Activity | Q1 2020 | Q1 2019 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $214.6 | ($627.4) | | Net cash used in investing activities | ($27.6) | ($60.3) | | Net cash (used in) provided by financing activities | ($50.2) | $809.1 | | **Net increase in cash and cash equivalents** | **$136.8** | **$121.4** | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, debt facilities, and ongoing litigation, including an antitrust suit from Sandoz and patent challenges from Liquidia Technologies - The company adopted new accounting standards for credit losses (ASU 2016-13) and goodwill impairment testing (ASU 2017-04) on January 1, 2020, with no material impact on the financial statements, apart from a minor adjustment to retained earnings[23](index=23&type=chunk)[24](index=24&type=chunk) - As of March 31, 2020, the company had an **$800.0 million** outstanding balance on its unsecured revolving credit facility, which was reclassified entirely to a non-current liability due to uncertainty surrounding the COVID-19 pandemic[46](index=46&type=chunk) - The company is involved in litigation with Sandoz over alleged anticompetitive conduct related to Remodulin cartridges and is facing patent challenges from Liquidia Technologies regarding its Tyvaso patents[75](index=75&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the impact of COVID-19 on operations and clinical trials, a **2%** revenue decline in Q1 2020, and the company's strong liquidity and R&D pipeline [Impact of COVID-19 on our Business](index=28&type=section&id=Impact%20of%20COVID-19%20on%20our%20Business) The company is closely monitoring the COVID-19 pandemic, which introduces significant uncertainty regarding near-term revenue and clinical trial timelines, leading to withdrawal of the 2020 revenue forecast - Due to the rapidly evolving situation and lack of visibility from the COVID-19 pandemic, the company is no longer able to predict whether its full-year 2020 net revenues will grow compared to 2019[84](index=84&type=chunk) - Most ongoing clinical studies have paused new patient enrollment, including trials for Tyvaso (PERFECT), ralinepag (ADVANCE), and Treprostinil Technosphere (BREEZE), which is expected to delay completion and data readouts[95](index=95&type=chunk) - In April 2020, the company observed a reduction in new patient prescriptions across all treprostinil-based products, believed to be due to patients' inability to visit physician offices[92](index=92&type=chunk)[96](index=96&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Total revenues for Q1 2020 decreased by **2%** to **$356.3 million**, primarily due to generic competition, while operating expenses significantly decreased, leading to improved operating and net income Net Product Sales by Product (in millions) | Product | Q1 2020 | Q1 2019 | % Change | | :--- | :--- | :--- | :--- | | Remodulin | $145.3 | $155.5 | (7)% | | Tyvaso | $102.9 | $103.8 | (1)% | | Orenitram | $69.0 | $58.4 | 18% | | Unituxin | $26.6 | $24.9 | 7% | | Adcirca | $12.5 | $20.0 | (38)% | | **Total revenues** | **$356.3** | **$362.6** | **(2)%** | - R&D expenses decreased by **$825.2 million** compared to Q1 2019, primarily because the prior-year period included an **$800.0 million** upfront payment for the ralinepag license and a **$12.5 million** payment for the MannKind collaboration[166](index=166&type=chunk) - Cost of product sales decreased by **$5.8 million**, mainly due to a **$3.3 million** decrease in royalty expense for Adcirca as sales declined from generic competition[164](index=164&type=chunk) [Research and Development](index=37&type=section&id=Research%20and%20Development) The company's R&D efforts focus on near-term and medium-term pipeline programs, including the Remunity pump launch, Tyvaso sNDA submission, and advancing the Implantable System for Remodulin, despite a setback with the Trevyent NDA - The Phase III INCREASE study of Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, with a supplemental NDA submission planned by mid-2020[138](index=138&type=chunk)[139](index=139&type=chunk) - In April 2020, the FDA issued a complete response letter (CRL) for the Trevyent new drug application, indicating that previously raised deficiencies have not been resolved[132](index=132&type=chunk) Key Near-Term Pipeline Programs (2020-2022) | Product | Indication | Status | | :--- | :--- | :--- | | Remunity (treprostinil) | PAH | Pharmacy-fill 510(k) cleared; Launch expected by July 2020 | | Tyvaso (treprostinil) | PH associated with IPF (WHO Group 3) | Phase III INCREASE study successful; sNDA submission planned mid-2020 | | Trevyent (treprostinil) | PAH | Evaluating FDA complete response letter to NDA | | Implantable System for Remodulin | PAH | U.S. launch pending satisfaction of regulatory requirements by Medtronic | [Financial Condition, Liquidity, and Capital Resources](index=51&type=section&id=Financial%20Condition%2C%20Liquidity%2C%20and%20Capital%20Resources) The company maintains strong liquidity with **$2.41 billion** in cash and investments, and believes it can fund operations, despite reclassifying its **$800.0 million** credit facility to non-current due to COVID-19 uncertainty Liquidity Summary (in millions) | Account | March 31, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $875.2 | $738.4 | | Total cash, cash equivalents and marketable investments | $2,412.5 | $2,253.4 | - The company decided not to repay a portion of its credit facility within one year out of an abundance of caution given the uncertainty surrounding the COVID-19 pandemic, reclassifying the entire **$800.0 million** balance as a non-current liability[172](index=172&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to market risk has not materially changed since December 31, 2019 - There have been no material changes in the company's market risk exposure since the end of the previous fiscal year[181](index=181&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of March 31, 2020, with no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures are effective as of the end of the period[182](index=182&type=chunk) Part II. Other Information [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 12 of the financial statements, detailing ongoing litigation, including an antitrust lawsuit from Sandoz and patent challenges from Liquidia Technologies - The company is engaged in an antitrust lawsuit with Sandoz Inc. and its partner, RareGen, LLC, concerning efforts to launch a generic version of Remodulin, with the court denying the plaintiffs' motion for a preliminary injunction[75](index=75&type=chunk) - Liquidia Technologies, Inc. has filed petitions to invalidate two of the company's patents related to treprostinil and has submitted an NDA for LIQ861, a potential competitor to Tyvaso[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks, including the significant new risk factor related to the COVID-19 pandemic, reliance on treprostinil-based products, increasing competition, and supply chain vulnerabilities - A new, significant risk factor details the potential adverse impacts of the COVID-19 pandemic on business operations, clinical trial timelines, and revenues due to social distancing, healthcare system strain, and economic downturn[212](index=212&type=chunk)[213](index=213&type=chunk) - The company relies heavily on sales of Remodulin, Tyvaso, and Orenitram, which face increasing competition from generics (Remodulin, Adcirca) and new therapies like Liquidia's LIQ861, potentially impacting revenues[190](index=190&type=chunk)[196](index=196&type=chunk) - The company is exposed to significant manufacturing and supply chain risks, including reliance on sole-source third parties for critical products and components, such as Medtronic for the Implantable System for Remodulin and MannKind for Treprostinil Technosphere[207](index=207&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=85&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2020, the company did not repurchase any outstanding equity securities or sell any unregistered equity securities - No unregistered sales of equity securities or share repurchases occurred during the first quarter of 2020[278](index=278&type=chunk) [Exhibits](index=86&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and certifications