If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider United Therapeutics (UTHR) . This company, which is in the Zacks Medical - Drugs industry, shows potential for another earnings beat.When looking at the last two reports, this drugmaker has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 14.42%, on average, in the last two quarter ...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Dr. Martine Rothblatt, Chairperson and Chief Executive Officer, will provide an overview and update on the company’s business during a presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will take place on Monday, January 8, 2024, from 11:15 a.m. to 11:55 a.m., Pacific Standard Time, and can be ...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Dr. Martine Rothblatt, Chairperson and Chief Executive Officer, will provide an overview and update on the company’s business during a presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.The presentation will take place on Monday, January 8, 2024, from 11:15 a.m. to 11:55 a.m., Pacific Standard Time, and can be a ...

Financial Performance - United Therapeutics reported total revenue of $609 million, an 18% increase year-over-year[19, 53] - Tyvaso (DPI and Nebulized) revenue reached $326 million, a 26% increase year-over-year[19, 53] - Remodulin revenue increased by 15% year-over-year to $131 million[19, 53] - Orenitram revenue increased by 5% year-over-year to $92 million, marking the second-highest revenue quarter for the product[19, 53, 57] - Unituxin revenue increased by 11% year-over-year to $51 million[19, 53] - The company's TTM (trailing twelve months) operating cash flow was $956 million[19] - United Therapeutics holds $4.9 billion in cash, cash equivalents, and marketable investments[19] Clinical Development & Pipeline - Enrollment is progressing in the TETON 1 and 2 studies for Tyvaso in Idiopathic Pulmonary Fibrosis (IPF), with approximately 60% and 50% enrollment, respectively, as of October 9, 2023[25] - The TETON PPF study for Tyvaso in Progressive Pulmonary Fibrosis (PPF) has enrolled its first patient in October 2023[27, 31] - The ADVANCE OUTCOMES study for Ralinepag in Pulmonary Arterial Hypertension (PAH) has enrolled over 510 patients as of October 1, 2023[37] Organ Manufacturing - United Therapeutics completed the acquisition of IVIVA Medical for $50 million, with a 2% royalty on any commercial sales[42] - The company anticipates the last xenokidney transplant in early 2024 and expects animal introduction in the first half of 2024 at the Designated Pathogen Free Facility (DPF)[45] - United Therapeutics has invested approximately $75 million in its Christiansburg, VA facility for xenotransplantation efforts, with construction completed in Q4/23[47]

[Part I. Financial Information (Unaudited)](index=3&type=section&id=Part%20I.%20Financial%20Information%20(Unaudited)) This section presents the unaudited consolidated financial statements and related disclosures for the specified interim periods [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents the unaudited consolidated financial statements, including the balance sheets, statements of operations, comprehensive income, stockholders' equity, and cash flows, along with detailed notes providing context on the company's financial position, performance, and accounting policies for the periods ended September 30, 2023, and December 31, 2022 [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheets provide a snapshot of the company's financial position as of September 30, 2023, and December 31, 2022, detailing assets, liabilities, and stockholders' equity. Key changes include an increase in total assets, driven by marketable investments and property, plant, and equipment, and a significant rise in total current liabilities, primarily due to a new current portion of the line of credit | Metric | Sep 30, 2023 (Millions) | Dec 31, 2022 (Millions) | Change (Millions) | % Change | | :-------------------------------- | :---------------------- | :---------------------- | :---------------- | :------- | | Total Assets | $7,023.6 | $6,044.5 | $979.1 | 16.2% | | Cash and cash equivalents | $1,107.7 | $961.2 | $146.5 | 15.2% | | Marketable investments (non-current) | $2,060.8 | $1,316.2 | $744.6 | 56.6% | | Property, plant, and equipment, net | $992.2 | $861.5 | $130.7 | 15.2% | | Total Current Liabilities | $744.1 | $343.2 | $400.9 | 116.8% | | Total Stockholders' Equity | $5,712.1 | $4,796.7 | $915.4 | 19.1% | - Total current liabilities increased significantly, primarily due to the reclassification of **$300.0 million** of the line of credit as a current liability, reflecting the intent to repay this amount within one year[5](index=5&type=chunk)[37](index=37&type=chunk) [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The Consolidated Statements of Operations show strong revenue growth and improved profitability for both the three and nine months ended September 30, 2023, compared to the prior year. Total revenues increased significantly, driven by product sales, while operating expenses also rose, primarily due to cost of sales and R&D. Net income and EPS saw substantial increases Three Months Ended September 30, 2023 vs 2022 | Metric | 2023 (Millions) | 2022 (Millions) | Change (Millions) | % Change | | :----------------------- | :-------------- | :-------------- | :---------------- | :------- | | Total revenues | $609.4 | $516.0 | $93.4 | 18.1% | | Total operating expenses | $282.4 | $201.7 | $80.7 | 40.0% | | Operating income | $327.0 | $314.3 | $12.7 | 4.0% | | Net income | $267.6 | $239.3 | $28.3 | 11.8% | | Diluted EPS | $5.38 | $4.91 | $0.47 | 9.6% | Nine Months Ended September 30, 2023 vs 2022 | Metric | 2023 (Millions) | 2022 (Millions) | Change (Millions) | % Change | | :----------------------- | :-------------- | :-------------- | :---------------- | :------- | | Total revenues | $1,712.8 | $1,444.8 | $268.0 | 18.5% | | Total operating expenses | $788.0 | $640.7 | $147.3 | 23.0% | | Operating income | $924.8 | $804.1 | $120.7 | 15.0% | | Net income | $767.7 | $595.2 | $172.5 | 29.0% | | Diluted EPS | $15.48 | $12.35 | $3.13 | 25.3% | - For the nine months ended September 30, 2023, cost of sales increased by **101% to $186.5 million**, research and development increased by **12% to $256.6 million**, and selling, general, and administrative increased by **8% to $344.9 million**[6](index=6&type=chunk) [Consolidated Statements of Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) The Consolidated Statements of Comprehensive Income show an increase in comprehensive income for both the three and nine months ended September 30, 2023, primarily driven by higher net income and a positive shift in unrealized gains on available-for-sale securities compared to losses in the prior year Comprehensive Income (Three Months Ended September 30) | Metric | 2023 (Millions) | 2022 (Millions) | Change (Millions) | | :-------------------------------------- | :-------------- | :-------------- | :---------------- | | Net income | $267.6 | $239.3 | $28.3 | | Unrealized gain (loss) on AFS securities, net of tax | $7.8 | $(18.8) | $26.6 | | Comprehensive income | $274.5 | $220.7 | $53.8 | Comprehensive Income (Nine Months Ended September 30) | Metric | 2023 (Millions) | 2022 (Millions) | Change (Millions) | | :-------------------------------------- | :-------------- | :-------------- | :---------------- | | Net income | $767.7 | $595.2 | $172.5 | | Unrealized gain (loss) on AFS securities, net of tax | $16.7 | $(61.8) | $78.5 | | Comprehensive income | $779.5 | $534.1 | $245.4 | - Unrealized gains on available-for-sale securities significantly improved, moving from a loss of **$(18.8) million in Q3 2022** to a gain of **$7.8 million in Q3 2023**, and from a loss of **$(61.8) million in 9M 2022** to a gain of **$16.7 million in 9M 2023**[8](index=8&type=chunk) [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) The Consolidated Statements of Stockholders' Equity show an increase in total stockholders' equity, primarily driven by net income and additional paid-in capital from stock option exercises and share-based compensation, partially offset by changes in accumulated other comprehensive loss - Total Stockholders' Equity increased from **$4,796.7 million** as of January 1, 2023, to **$5,712.1 million** as of September 30, 2023[10](index=10&type=chunk) - Key drivers of the equity increase for the nine months ended September 30, 2023, include net income of **$767.7 million**, unrealized gains on available-for-sale securities of **$16.7 million**, proceeds from the exercise of stock options of **$90.7 million**, and share-based compensation of **$52.3 million**[10](index=10&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The Consolidated Statements of Cash Flows indicate a significant increase in net cash provided by operating activities and financing activities for the nine months ended September 30, 2023, compared to the prior year, while cash used in investing activities also increased. This resulted in a substantial net increase in cash and cash equivalents Cash Flows (Nine Months Ended September 30) | Metric | 2023 (Millions) | 2022 (Millions) | Change (Millions) | % Change | | :-------------------------------- | :-------------- | :-------------- | :---------------- | :------- | | Net cash provided by operating activities | $827.3 | $674.3 | $153.0 | 22.7% | | Net cash used in investing activities | $(761.7) | $(622.2) | $(139.5) | (22.4)% | | Net cash provided by financing activities | $80.9 | $19.9 | $61.0 | 306.5% | | Net increase in cash and cash equivalents | $146.5 | $72.0 | $74.5 | 103.5% | - The increase in net cash used in investing activities was primarily due to a **$74.3 million** increase in cash used for marketable investments, a **$52.4 million** increase in purchases of property, plant, and equipment, and **$14.3 million** in deposits[13](index=13&type=chunk)[173](index=173&type=chunk) - The increase in net cash provided by financing activities was primarily driven by a **$57.8 million** increase in proceeds from the exercise of stock options and a **$4.8 million** decrease in debt issuance costs[13](index=13&type=chunk)[174](index=174&type=chunk) [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The Notes to Consolidated Financial Statements provide detailed disclosures on the company's accounting policies, financial instruments, debt, share-based compensation, income taxes, segment information, and significant legal proceedings. They also highlight recent acquisitions and merger agreements, offering crucial context to the financial statements [1. Organization and Business Description](index=9&type=section&id=1.%20Organization%20and%20Business%20Description) United Therapeutics Corporation is a biotechnology company focused on developing and commercializing products for chronic and life-threatening conditions. In 2021, it converted to a Delaware public benefit corporation (PBC) with a dual purpose: developing novel pharmaceutical therapies and expanding the availability of transplantable organs. The company markets several FDA-approved therapies, including Tyvaso DPI, nebulized Tyvaso, Remodulin, Orenitram, Unituxin, and Adcirca, with international sales for some products - United Therapeutics Corporation is a biotechnology company focused on developing and commercializing innovative products for chronic and life-threatening conditions[15](index=15&type=chunk) - In 2021, the company converted to a Delaware public benefit corporation (PBC) with the purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs[15](index=15&type=chunk) - The company markets FDA-approved therapies including Tyvaso DPI, nebulized Tyvaso, Remodulin, Orenitram, Unituxin, and Adcirca, with international revenues from nebulized Tyvaso, Remodulin, and Unituxin[16](index=16&type=chunk) [2. Basis of Presentation](index=9&type=section&id=2.%20Basis%20of%20Presentation) The unaudited consolidated financial statements are prepared in accordance with SEC rules for interim financial information, not full GAAP. They include all necessary adjustments for fair presentation as of September 30, 2023, and December 31, 2022, and for the three and nine-month periods ended September 30, 2023 and 2022. Interim results are not indicative of full-year performance, and no new accounting standards were adopted or are pending adoption during the period - The unaudited consolidated financial statements are prepared in accordance with SEC rules for interim financial information and do not include all information required by U.S. GAAP for complete financial statements[17](index=17&type=chunk) - Management believes the statements contain all necessary adjustments for fair presentation, but interim results are not necessarily indicative of full-year results[18](index=18&type=chunk) - No new accounting standards were adopted or are yet to be adopted during the period[19](index=19&type=chunk) [3. Investments](index=10&type=section&id=3.%20Investments) The company's investment portfolio includes available-for-sale debt securities and equity securities. Available-for-sale debt securities, primarily U.S. government and corporate debt, are recorded at fair value with unrealized losses attributed to interest rate changes, not credit risk. Equity investments in publicly-traded and privately-held companies are also held, with fair value changes for publicly-traded equities recorded in operations Available-for-Sale Debt Securities (Fair Value, Sep 30, 2023) | Category | Amortized Cost (Millions) | Gross Unrealized Gains (Millions) | Gross Unrealized Losses (Millions) | Fair Value (Millions) | | :------------------------------ | :------------------------ | :------------------------ | :------------------------- | :-------------------- | | U.S. government and agency securities | $3,167.6 | $— | $(41.3) | $3,126.3 | | Corporate debt securities | $716.1 | $— | $(11.6) | $704.5 | | **Total** | **$3,883.7** | **$—** | **$(52.9)** | **$3,830.8** | - Unrealized losses on available-for-sale debt securities are believed to be a direct result of the current interest rate environment and do not represent an indication of credit loss. The company does not intend to sell these investments prior to maturity[23](index=23&type=chunk) - Investments in equity securities with readily determinable fair values totaled **$16.9 million** as of September 30, 2023, with net unrealized losses of **$13.8 million** recognized for the nine months ended September 30, 2023, in other expense, net[26](index=26&type=chunk)[30](index=30&type=chunk) - Non-controlling equity investments in privately-held companies aggregated **$28.5 million** as of September 30, 2023, measured at cost less impairment and adjusted for observable price changes[27](index=27&type=chunk) [4. Fair Value Measurements](index=11&type=section&id=4.%20Fair%20Value%20Measurements) The company classifies assets and liabilities subject to fair value measurements into a three-level hierarchy. As of September 30, 2023, total assets measured at fair value were $4,366.7 million, predominantly in Level 1 (money market funds, time deposits, equity securities) and Level 2 (U.S. government and agency securities, corporate debt securities). Contingent consideration liabilities, measured using Level 3 inputs, decreased by $1.6 million during the period Assets and Liabilities Subject to Fair Value Measurements (Sep 30, 2023) | Category | Level 1 (Millions) | Level 2 (Millions) | Level 3 (Millions) | Balance (Millions) | | :------------------------------ | :----------------- | :----------------- | :----------------- | :----------------- | | **Assets:** | | | | | | Money market funds | $210.3 | $— | $— | $210.3 | | Time deposits | $308.7 | $— | $— | $308.7 | | U.S. government and agency securities | $— | $3,126.3 | $— | $3,126.3 | | Corporate debt securities | $— | $704.5 | $— | $704.5 | | Equity securities | $16.9 | $— | $— | $16.9 | | Contingent consideration | $— | $— | $— | $— | | **Total assets** | **$535.9** | **$3,830.8** | **$—** | **$4,366.7** | | **Liabilities:** | | | | | | Contingent consideration | $— | $— | $18.1 | $18.1 | | **Total liabilities** | **$—** | **$—** | **$18.1** | **$18.1** | - The fair value of contingent consideration liabilities decreased by **$1.6 million** from December 31, 2022, to September 30, 2023, with the gain recorded within research and development in the consolidated statements of operations[30](index=30&type=chunk) [5. Inventories](index=14&type=section&id=5.%20Inventories) Inventories are valued at the lower of cost (FIFO method) or net realizable value. As of September 30, 2023, total inventories were $104.3 million, a slight increase from $102.0 million at December 31, 2022, with increases in raw materials and work-in-progress, and a decrease in finished goods Inventories, Net (Millions) | Category | Sep 30, 2023 | Dec 31, 2022 | | :--------------- | :----------- | :----------- | | Raw materials | $21.5 | $18.0 | | Work-in-progress | $34.9 | $33.3 | | Finished goods | $47.9 | $50.7 | | **Total inventories** | **$104.3** | **$102.0** | - Total inventories increased by **$2.3 million** from December 31, 2022, to September 30, 2023[32](index=32&type=chunk) [6. Property, Plant, and Equipment](index=14&type=section&id=6.%20Property,%20Plant,%20and%20Equipment) Net property, plant, and equipment increased to $992.2 million as of September 30, 2023, from $861.5 million at December 31, 2022. This growth was primarily driven by significant investments in buildings under construction, reflecting ongoing capital expenditure for facilities Property, Plant, and Equipment, Net (Millions) | Category | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------------ | :----------- | :----------- | | Land and land improvements | $146.7 | $142.7 | | Buildings, building improvements, and leasehold improvements | $671.5 | $636.7 | | Buildings under construction | $221.7 | $110.9 | | Furniture, equipment, and vehicles | $372.8 | $353.9 | | Less—accumulated depreciation | $(420.5) | $(382.7) | | **Property, plant, and equipment, net** | **$992.2** | **$861.5** | - Net property, plant, and equipment increased by **$130.7 million (15.2%)** from December 31, 2022, to September 30, 2023, with buildings under construction nearly doubling[33](index=33&type=chunk) [7. Debt](index=14&type=section&id=7.%20Debt) The company maintains an unsecured revolving credit facility of up to $2.0 billion, with an outstanding balance of $800.0 million as of September 30, 2023. $300.0 million of this balance was reclassified as a current liability, reflecting the intent to repay it within one year. The credit agreement's maturity was extended to March 2028, and the company remains in compliance with all covenants - The company has an unsecured revolving credit facility of up to **$2.0 billion**, with the maturity date extended to March 2028[34](index=34&type=chunk) - The outstanding aggregate principal balance under the Credit Agreement was **$800.0 million** as of September 30, 2023[37](index=37&type=chunk) - **$300.0 million** of the outstanding balance was reclassified as a current liability as of September 30, 2023, due to the intent to repay this amount within one year. The company was in compliance with all covenants[37](index=37&type=chunk)[38](index=38&type=chunk) [8. Share-Based Compensation](index=15&type=section&id=8.%20Share-Based%20Compensation) Share-based compensation expense for the nine months ended September 30, 2023, decreased by 46% to $22.5 million, primarily due to a significant benefit from STAP awards. However, RSU expense increased by 62%, reflecting new performance-based grants. The company uses stock options, RSUs, and an ESPP, with STAP awards being cash-settled liabilities re-measured each period Share-Based Compensation Expense (Benefit) (Millions) | Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Stock options | $6.0 | $5.7 | $12.5 | $16.8 | | RSUs | $12.5 | $9.9 | $38.3 | $23.6 | | STAP awards | $2.1 | $(18.5) | $(29.8) | $0.2 | | ESPP | $0.5 | $0.5 | $1.5 | $1.4 | | **Total before tax** | **$21.1** | **$(2.4)** | **$22.5** | **$42.0** | - The decrease in total share-based compensation expense for the nine months ended September 30, 2023, was primarily due to a **$30.0 million STAP benefit**, driven by a **19% decrease** in the company's stock price during the period[166](index=166&type=chunk) - Unrecognized compensation cost related to stock options was **$31.8 million** (weighted average remaining vesting period of **2.3 years**) and for RSUs was **$141.4 million** (weighted average remaining vesting period of **3.2 years**) as of September 30, 2023[48](index=48&type=chunk)[53](index=53&type=chunk) - The aggregate liability for cash-settled STAP awards was **$40.6 million** as of September 30, 2023, down from **$80.8 million** at December 31, 2022, and is classified as a current liability[55](index=55&type=chunk) [9. Earnings Per Common Share](index=19&type=section&id=9.%20Earnings%20Per%20Common%20Share) Basic and diluted earnings per common share increased significantly for both the three and nine months ended September 30, 2023, reflecting higher net income. Dilutive securities, including stock options, RSUs, and ESPP shares, contributed to the difference between basic and diluted EPS Net Income Per Common Share | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Basic EPS | $5.71 | $5.26 | $16.44 | $13.14 | | Diluted EPS | $5.38 | $4.91 | $15.48 | $12.35 | | Weighted average outstanding shares — basic | 46.9 | 45.5 | 46.7 | 45.3 | | Effect of dilutive securities | 2.8 | 3.2 | 2.9 | 2.9 | | Weighted average shares — diluted | 49.7 | 48.7 | 49.6 | 48.2 | [10. Income Taxes](index=20&type=section&id=10.%20Income%20Taxes) The effective income tax rate (ETR) for the nine months ended September 30, 2023, decreased to 22% from 23% in the prior year, primarily due to increased excess tax benefits from share-based compensation, partially offset by a rise in the reserve for uncertain tax positions. Unrecognized tax benefits, including interest, increased to $24.8 million - Income tax expense for the nine months ended September 30, 2023, was **$211.2 million**, with an effective income tax rate (ETR) of **22%**, down from **23%** in the prior year[65](index=65&type=chunk) - The decrease in ETR was primarily due to increased excess tax benefits from share-based compensation, partially offset by an increase in the reserve for uncertain tax positions[65](index=65&type=chunk) - Unrecognized tax benefits, including related interest, were approximately **$24.8 million** as of September 30, 2023, an increase from **$15.9 million** at December 31, 2022[66](index=66&type=chunk) [11. Segment Information](index=20&type=section&id=11.%20Segment%20Information) The company operates as a single operating segment, with the CEO managing resources on a consolidated basis. Total revenues for the nine months ended September 30, 2023, were $1,712.8 million, with the United States accounting for the vast majority ($1,616.3 million). Tyvaso DPI showed significant revenue growth, while nebulized Tyvaso sales decreased following the launch of Tyvaso DPI - The company operates as one operating segment, with the CEO managing and allocating resources on a consolidated basis[67](index=67&type=chunk) Total Revenues by Product (Nine Months Ended September 30, Millions) | Product | 2023 | 2022 | Change | | :---------------- | :----- | :----- | :----- | | Tyvaso DPI | $517.4 | $66.1 | +$451.3 | | Nebulized Tyvaso | $365.7 | $564.6 | -$198.9 | | Remodulin | $379.7 | $377.7 | +$2.0 | | Orenitram | $275.3 | $249.3 | +$26.0 | | Unituxin | $144.7 | $146.2 | -$1.5 | | Adcirca | $22.1 | $30.9 | -$8.8 | | Other | $7.9 | $10.0 | -$2.1 | | **Total Revenues** | **$1,712.8** | **$1,444.8** | **+$268.0** | Geographic Revenues (Nine Months Ended September 30, Millions) | Region | 2023 | 2022 | | :------------- | :----- | :----- | | United States | $1,616.3 | $1,350.4 | | Rest of World | $96.5 | $94.4 | | **Total** | **$1,712.8** | **$1,444.8** | - Two U.S. distributors accounted for **51%** and **34%** of total revenues for the nine months ended September 30, 2023[70](index=70&type=chunk) [12. Litigation](index=21&type=section&id=12.%20Litigation) The company is involved in several significant litigations, including a breach of contract claim with Sandoz regarding Remodulin, patent and trade secret disputes with Liquidia concerning Tyvaso DPI and nebulized Tyvaso, and multiple lawsuits from MSP Recovery, Humana, and United Healthcare related to charitable contributions to patient assistance programs. Additionally, the company is litigating against HRSA and HHS regarding its 340B program contract pharmacy policies - Sandoz Litigation: The court granted summary judgment in the company's favor on antitrust claims, but a breach of contract claim regarding Remodulin infusion devices will proceed to trial for damages[74](index=74&type=chunk)[75](index=75&type=chunk) - Liquidia Litigation: A federal court barred FDA approval of Liquidia's Yutrepia until May 2027 due to infringement of the '793 patent, a decision affirmed by the appellate court. Separately, the PTAB found '793 patent claims unpatentable, which the company is appealing[83](index=83&type=chunk)[84](index=84&type=chunk) - MSP Recovery, Humana, and United Healthcare Litigations: Multiple lawsuits allege RICO and state law violations concerning charitable contributions to patient assistance programs (CVC); motions to dismiss are pending[88](index=88&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) - 340B Program Litigation: The company is challenging HRSA's interpretation of 340B contract pharmacy policies; a district court granted summary judgment in the company's favor, but HRSA has appealed[97](index=97&type=chunk) [13. Subsequent Events](index=25&type=section&id=13.%20Subsequent%20Events) Post-period, the company completed the acquisition of IVIVA Medical, Inc. for approximately $50.0 million upfront, focused on manufactured kidney products, and entered into a merger agreement to acquire Miromatrix Medical, Inc. for an aggregate of approximately $91.0 million upfront, with potential earnouts, to further its organ manufacturing initiatives - In October 2023, the company acquired IVIVA Medical, Inc., an early-stage company developing manufactured kidney products, for an upfront cash payment of approximately **$50.0 million**, plus potential earnout consideration[99](index=99&type=chunk) - On October 29, 2023, the company entered into an agreement to acquire Miromatrix Medical, Inc. for **$3.25 per share** in cash (approximately **$91.0 million** aggregate), with an additional **$1.75 per share** (approximately **$54.0 million** aggregate) contingent on the first human implantation of mirokidney™ by the end of 2025[100](index=100&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's Discussion and Analysis provides an overview of the company's financial performance, market dynamics, and strategic initiatives. It highlights strong revenue growth driven by Tyvaso DPI, ongoing R&D investments in organ manufacturing and new indications, and the impact of generic competition and regulatory challenges. The section also details liquidity, capital resources, and critical accounting policies [Overview of Marketed Products](index=28&type=section&id=Overview%20of%20Marketed%20Products) The company markets several key commercial products, primarily treprostinil-based therapies like Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram, along with Unituxin and Adcirca. Revenues are generated through non-exclusive and exclusive distribution agreements in the U.S. and internationally. Sales can fluctuate based on distributor ordering patterns, which may not always align with immediate patient demand - Key commercial products include Tyvaso DPI, nebulized Tyvaso, Remodulin, Orenitram (all treprostinil-based), Unituxin, and Adcirca[106](index=106&type=chunk)[109](index=109&type=chunk) - Distribution in the U.S. is primarily through Accredo and CVS Specialty for treprostinil-based therapies, ASD Specialty Healthcare for Unituxin, and Eli Lilly for Adcirca[106](index=106&type=chunk) - Sales of treprostinil-based therapies can vary based on the timing and magnitude of distributor orders, not always precisely reflecting changes in patient demand[107](index=107&type=chunk) [Generic Competition and Challenges to our Intellectual Property Rights](index=28&type=section&id=Generic%20Competition%20and%20Challenges%20to%20our%20Intellectual%20Property%20Rights) The company faces ongoing generic competition for Remodulin, which has impacted international revenues, and potential future generic competition for nebulized Tyvaso and Orenitram starting in 2026 and 2027, respectively. Significant patent litigation with Liquidia regarding Yutrepia, a competing dry powder treprostinil, is ongoing, with a federal court barring FDA approval until May 2027, though PTAB challenges continue. Adcirca already faces material adverse impact from generic competition - Generic competition for Remodulin has led to decreased international revenues, though U.S. sales erosion has been limited to date[108](index=108&type=chunk)[110](index=110&type=chunk) - Settlement agreements allow generic versions of nebulized Tyvaso and Orenitram to enter the U.S. market starting in **January 2026** and **June/December 2027**, respectively[111](index=111&type=chunk) - Ongoing patent litigation with Liquidia regarding its Yutrepia product has resulted in a federal court judgment barring FDA approval until **May 2027** due to infringement of the '793 patent, a decision affirmed on appeal. However, Liquidia continues to challenge patents through IPR proceedings[114](index=114&type=chunk)[116](index=116&type=chunk) - FDA granted nebulized Tyvaso three-year clinical trial exclusivity for PH-ILD, expiring **March 2024**, which also covers Tyvaso DPI and precludes Yutrepia PH-ILD approval before then[118](index=118&type=chunk) - Generic competition for Adcirca, launched in August 2018, has had a material adverse impact on its net product sales[120](index=120&type=chunk) [Operating Expenses](index=30&type=section&id=Operating%20Expenses) Operating expenses include cost of sales, research and development, and selling, general, and administrative expenses. Cost of sales covers manufacturing, royalties, and distribution. R&D focuses on product development, clinical trials, and third-party arrangements. SG&A includes commercialization costs and corporate support. Share-based compensation, particularly cash-settled STAP awards, can introduce significant volatility to operating expenses due to re-measurement at each reporting period - Cost of sales primarily includes manufacturing costs, royalty and sales-based milestone payments, direct and indirect distribution costs, and inventory reserves[123](index=123&type=chunk) - Research and development expenses cover product development, preclinical and clinical studies, clinical manufacturing, regulatory costs, and payments to third-party contract manufacturers and licensors[124](index=124&type=chunk) - Selling, general, and administrative expenses include commercialization costs, product marketing, sales operations, and corporate support functions[126](index=126&type=chunk) - Share-based compensation, especially for cash-settled STAP awards, can create substantial volatility in operating expenses due to re-measurement of fair value at each financial reporting period, influenced by stock price changes[128](index=128&type=chunk) [Research and Development](index=31&type=section&id=Research%20and%20Development) The company's R&D efforts are focused on expanding indications for nebulized Tyvaso (TETON studies for IPF and PPF), developing Ralinepag for PAH, and advancing organ manufacturing technologies. Significant progress has been made in xenotransplantation and ex vivo lung perfusion, with recent acquisitions of IVIVA Medical and Miromatrix Medical to bolster organ manufacturing capabilities. The RemoPro program was terminated - Ongoing Phase 3 TETON 1 and TETON 2 studies are evaluating nebulized Tyvaso for Idiopathic Pulmonary Fibrosis (IPF), with a routine safety review in September 2023 recommending continuation without modification[131](index=131&type=chunk)[136](index=136&type=chunk) - A Phase 3 TETON PPF study for Progressive Pulmonary Fibrosis (PPF) enrolled its first patient in October 2023, targeting **698 patients**[134](index=134&type=chunk) - The Phase 3 ADVANCE OUTCOMES study for Ralinepag in PAH patients is ongoing, with a data monitoring committee recommending continuation in October 2023; the ADVANCE CAPACITY study was discontinued[137](index=137&type=chunk) - Organ manufacturing programs include xenotransplantation (UKidneys™, UThymoKidneys™, UHearts™), regenerative medicine, 3-D organ bioprinting, and ex vivo lung perfusion, with a clinical-scale xenograft facility expected operational in **H1 2024**[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk) - Recent achievements in organ manufacturing include successful UHeart tests in brain-dead organ donors, over **300 lung transplants** using ex vivo lung perfusion, and the acquisitions of IVIVA Medical and Miromatrix Medical to enhance manufactured kidney products[143](index=143&type=chunk)[145](index=145&type=chunk) - The RemoPro program, focused on developing a prodrug form of Remodulin, was terminated during the second quarter of 2023[145](index=145&type=chunk) [Future Prospects](index=34&type=section&id=Future%20Prospects) Near-term revenue growth is anticipated from Tyvaso DPI sales, nebulized Tyvaso's PH-ILD label expansion, and Orenitram's continued patient growth, along with modest price increases. Medium- and longer-term growth will be driven by pipeline products and new indications, particularly in organ manufacturing. The company plans $650 million in capital expenditures for 2023-2025, mainly for a new Tyvaso DPI manufacturing facility, and faces intense competition from established pharmaceutical companies and new therapies - Overall revenue growth is anticipated to be driven primarily by sales of Tyvaso DPI, expansion of nebulized Tyvaso's label to include PH-ILD, continued growth in Orenitram patients, and modest price increases[146](index=146&type=chunk) - Medium- and longer-term revenue growth is expected from new products and indications in the pipeline, including organ manufacturing and transplantation technologies[146](index=146&type=chunk) - The company has budgeted approximately **$650 million** for capital expenditures during **2023-2025**, with the majority dedicated to constructing a new Tyvaso DPI manufacturing facility, funded by cash on hand[148](index=148&type=chunk) - The company operates in a highly competitive market with large pharmaceutical companies and numerous investigational products in late-stage development that could erode market share[149](index=149&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) The company reported strong revenue growth for the three and nine months ended September 30, 2023, primarily driven by a 225% increase in Tyvaso DPI sales for the quarter and 683% for the nine-month period. Nebulized Tyvaso sales decreased due to the shift to DPI. Cost of sales increased significantly due to Tyvaso DPI royalties and product costs. Share-based compensation expense showed volatility, with a large increase in Q3 due to STAP awards but an overall decrease for the nine-month period Total Revenues (Millions) | Period | 2023 | 2022 | Dollar Change | Percentage Change | | :------------------------------ | :----- | :----- | :------------ | :---------------- | | Three Months Ended Sep 30 | $609.4 | $516.0 | $93.4 | 18% | | Nine Months Ended Sep 30 | $1,712.8 | $1,444.8 | $268.0 | 19% | - Tyvaso DPI net product sales increased by **225%** for the three months and **683%** for the nine months ended September 30, 2023, primarily due to increased quantities sold following its commercial launch in June 2022 and continued PH-ILD patient utilization[151](index=151&type=chunk)[153](index=153&type=chunk) - Nebulized Tyvaso net product sales decreased by **38%** for the three months and **35%** for the nine months ended September 30, 2023, primarily due to a decrease in quantities sold following the commercial launch of Tyvaso DPI[151](index=151&type=chunk)[153](index=153&type=chunk) - Cost of sales increased by **88%** for the three months and **101%** for the nine months ended September 30, 2023, primarily due to increased Tyvaso DPI royalty expense and product costs[158](index=158&type=chunk)[159](index=159&type=chunk) - Research and development expense increased by **28%** for the three months and **12%** for the nine months ended September 30, 2023, primarily due to increased expenditures related to the TETON 1 and TETON 2 clinical studies and organ manufacturing projects[160](index=160&type=chunk)[162](index=162&type=chunk) - Share-based compensation expense increased by **979%** for the three months ended September 30, 2023, primarily due to an increase in STAP expense driven by a **2% increase** in stock price. For the nine months, it decreased by **46%** due to a STAP benefit from a **19% decrease** in stock price[165](index=165&type=chunk)[166](index=166&type=chunk) [Financial Condition, Liquidity, and Capital Resources](index=39&type=section&id=Financial%20Condition,%20Liquidity,%20and%20Capital%20Resources) The company's liquidity is strong, with cash and cash equivalents and marketable investments totaling $4,936.3 million as of September 30, 2023, an increase of 19% from December 31, 2022. Operating activities provided $827.3 million in cash for the nine months, while investing activities used $761.7 million, largely for marketable investments and property, plant, and equipment. Financing activities provided $80.9 million, primarily from stock option exercises Cash and Cash Equivalents and Marketable Investments (Millions) | Category | Sep 30, 2023 | Dec 31, 2022 | Dollar Change | Percentage Change | | :------------------------------------------ | :----------- | :----------- | :------------ | :---------------- | | Cash and cash equivalents | $1,107.7 | $961.2 | $146.5 | 15% | | Marketable investments—current | $1,767.8 | $1,877.5 | $(109.7) | (6)% | | Marketable investments—non-current | $2,060.8 | $1,316.2 | $744.6 | 57% | | **Total** | **$4,936.3** | **$4,154.9** | **$781.4** | **19%** | Cash Flows (Nine Months Ended September 30, Millions) | Activity | 2023 | 2022 | Dollar Change | Percentage Change | | :-------------------------------- | :----- | :----- | :------------ | :---------------- | | Net cash provided by operating activities | $827.3 | $674.3 | $153.0 | 23% | | Net cash used in investing activities | $(761.7) | $(622.2) | $(139.5) | (22)% | | Net cash provided by financing activities | $80.9 | $19.9 | $61.0 | 307% | - The increase in net cash used in investing activities was primarily due to a **$74.3 million** increase in cash used for marketable investments and a **$52.4 million** increase in purchases of property, plant, and equipment[173](index=173&type=chunk) - The increase in net cash provided by financing activities was primarily due to a **$57.8 million** increase in proceeds from the exercise of stock options[174](index=174&type=chunk) [Summary of Critical Accounting Policies and Estimates](index=40&type=section&id=Summary%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies and estimates, which involve significant management judgment and assumptions, remain unchanged from those disclosed in the 2022 Annual Report on Form 10-K. These estimates are inherently uncertain, and actual results may differ - There have been no material changes to the company's critical accounting policies and estimates as disclosed in its 2022 Annual Report on Form 10-K[175](index=175&type=chunk) [Recently Issued Accounting Standards](index=40&type=section&id=Recently%20Issued%20Accounting%20Standards) There were no new accounting standards adopted during the current period, nor are there any new standards not yet adopted that are expected to have a material impact on the financial statements - No new accounting standards were adopted during the period, and none are yet adopted that are expected to have a material impact[176](index=176&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to market risk, including interest rate risk, foreign currency risk, and equity price risk, has not materially changed since December 31, 2022 - The company's exposure to market risk has not materially changed since December 31, 2022[177](index=177&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) As of September 30, 2023, the Chairperson and CEO and CFO and Treasurer concluded that the company's disclosure controls and procedures are effective, providing reasonable assurance for timely and accurate financial reporting. No material changes in internal control over financial reporting occurred during the period - As of September 30, 2023, the Chairperson and CEO and CFO and Treasurer concluded that disclosure controls and procedures are effective[178](index=178&type=chunk) - There have been no material changes in internal control over financial reporting during the period covered by this report[178](index=178&type=chunk) [Part II. Other Information](index=41&type=section&id=Part%20II.%20Other%20Information) This section provides additional information not covered in Part I, including legal proceedings, risk factors, equity security sales, and other disclosures [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed litigation disclosures from Note 12 to the consolidated financial statements, covering ongoing legal disputes such as the Sandoz litigation, Liquidia patent and trade secret disputes, MSP Recovery and related lawsuits concerning patient assistance programs, and the 340B program litigation with HRSA and HHS - Refers to Note 12—Litigation in the consolidated financial statements for detailed information on legal proceedings[180](index=180&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including heavy reliance on treprostinil-based therapies, potential clinical trial failures, intense competition from established and new drugs, and pricing pressures from third-party payers and government reforms like the IRA. Manufacturing strategy exposes risks related to capacity and third-party reliance. Legal and regulatory compliance, intellectual property challenges, and data security breaches also pose substantial threats. Financial risks include the need for additional financing and market volatility affecting investments. Acquisitions also carry inherent integration risks [Risks Related to Our Products and Our Operations](index=41&type=section&id=Risks%20Related%20to%20Our%20Products%20and%20Our%20Operations) Operational risks include heavy reliance on treprostinil-based therapies, potential for clinical trial failures, and intense competition from existing and new drugs (e.g., Liquidia's Yutrepia, Merck's sotatercept). Commercial success depends on adequate reimbursement from third-party payers, which is under increasing pressure from government reforms like the IRA. Manufacturing strategy faces significant risks from capacity limitations, reliance on third parties, and supply chain disruptions. Product liability claims, negative attention from special interest groups, and the ability to attract and retain key personnel are also critical concerns - The company relies heavily on sales of its treprostinil-based therapies (Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram), and decreased sales could materially impact operations[181](index=181&type=chunk) - Clinical trials for new products or expanded indications may be discontinued, delayed, or unsuccessful, preventing market approval[182](index=182&type=chunk)[183](index=183&type=chunk) - The company faces intense competition from numerous established and newly developed drugs, including generic versions of Adcirca and Remodulin, and new therapies like Liquidia's Yutrepia and Merck's sotatercept[185](index=185&type=chunk) - Commercial success depends on adequate coverage and reimbursement from third-party payers, which is subject to increasing pricing and reimbursement pressures, including potential impacts from the Inflation Reduction Act of 2022 (IRA)[187](index=187&type=chunk) - Manufacturing strategy exposes significant risks, including the need to increase Tyvaso DPI manufacturing capacity, reliance on third-party manufacturers (e.g., MannKind for Tyvaso DPI, DEKA for Remunity Pump), and potential supply chain disruptions[189](index=189&type=chunk)[192](index=192&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) [Risks Related to Legal Compliance](index=45&type=section&id=Risks%20Related%20to%20Legal%20Compliance) The company must comply with extensive and evolving laws and regulations globally, including those from the FDA and international counterparts, which govern product approval, manufacturing, marketing, and sales. Failure to comply can lead to delays, enforcement actions, and significant penalties. Marketing practices are subject to anti-kickback and false claims statutes. Government healthcare reforms, particularly the IRA, are expected to increase rebate liabilities and pricing pressures. The 340B program contract pharmacy policy also exposes the company to potential enforcement actions and adverse publicity. Patient assistance programs are under scrutiny, and improper handling of hazardous materials or misuse of social media platforms present additional compliance risks - Failure to comply with extensive domestic and international laws and regulations governing product development, manufacturing, marketing, and sales could delay or prevent commercialization and lead to adverse regulatory actions[207](index=207&type=chunk) - Business activities are subject to anti-kickback and false claims statutes, the Foreign Corrupt Practices Act, and the United Kingdom Bribery Act, with potential for substantial penalties for non-compliance[210](index=210&type=chunk) - The Inflation Reduction Act of 2022 (IRA) will significantly impact the pharmaceutical industry by requiring price negotiations with Medicare, imposing inflation-based rebates, and replacing the Medicare Part D coverage gap discount program, likely increasing rebate liabilities for products like Tyvaso DPI and Orenitram[215](index=215&type=chunk)[216](index=216&type=chunk) - The company may face enforcement action or penalties in connection with its 340B program contract pharmacy policy, which is currently under appeal after a district court ruling in the company's favor[231](index=231&type=chunk)[232](index=232&type=chunk) - Patient assistance programs are under increasing scrutiny, and actions by government agencies or the implementation of co-pay accumulator programs could reduce demand for products[233](index=233&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) [Risks Related to Our Intellectual Property and Data Privacy](index=49&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20and%20Data%20Privacy) The company's business relies heavily on licensed intellectual property, and termination or breach of these agreements could lead to loss of product rights. Patent protection for treprostinil-based therapies is limited, with some patents expiring and others facing challenges from generic competitors. Patent litigation is costly and uncertain, and trade secrets may not be adequately protected. Third-party infringement claims could result in significant costs or loss of sales. Information technology security breaches pose risks to sensitive data, potentially leading to legal liabilities and reputational damage - The company's business depends on licensed intellectual property rights, and termination or breach of these agreements could result in the loss of rights to develop, manufacture, and sell related products[240](index=240&type=chunk) - Patent protection for treprostinil-based therapies is limited, with some U.S. patents having expired or set to expire, and ongoing challenges from competitors (e.g., Liquidia) could invalidate patents or lead to generic competition[241](index=241&type=chunk)[243](index=243&type=chunk) - Reliance on trade secrets to protect proprietary know-how carries the risk that confidentiality agreements may not prevent unauthorized use or disclosure, or that competitors could lawfully obtain or independently develop such information[245](index=245&type=chunk) - Allegations of patent infringement by third parties could lead to costly litigation, royalty payments that erode profits, or the loss of ability to sell related products[246](index=246&type=chunk)[247](index=247&type=chunk) - Information technology security breaches or other disruptions could compromise sensitive data, including intellectual property and personally identifiable information, leading to legal claims, operational disruption, and reputational damage[248](index=248&type=chunk) [Risks Related to Our Financing Capacity, Indebtedness, and Investments](index=51&type=section&id=Risks%20Related%20to%20Our%20Financing%20Capacity,%20Indebtedness,%20and%20Investments) The company may need additional financing for unplanned or planned expenditures, and its ability to obtain it on favorable terms is not guaranteed, potentially limiting product development. Inability to service or repay its $800.0 million outstanding debt could materially affect its financial position. The investment portfolio is subject to market, interest, operational, and credit risks, which could reduce its value. Acquisitions, such as IVIVA and Miromatrix, carry inherent risks related to integration, increased costs, and potential dilution - The company may need additional financing for unplanned or planned expenditures, and an inability to obtain it on favorable terms could delay clinical studies or curtail operations[250](index=250&type=chunk) - The inability to generate sufficient cash to service or repay its **$800.0 million** outstanding indebtedness could materially and adversely affect the company's financial position and results of operations[251](index=251&type=chunk) - The company's investment portfolio, including corporate debt and strategic equity investments, is subject to market, interest, operational, and credit risks that may reduce its value or liquidity[252](index=252&type=chunk) - Acquisitions, such as IVIVA Medical and Miromatrix Medical, involve numerous risks, including integration challenges, potential increases in operating costs, diversion of management's attention, and potential dilution or incurrence of debt[253](index=253&type=chunk) [Risks Related to Our Common Stock](index=52&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The price of the company's common stock is highly volatile, influenced by financial results, clinical trial outcomes, competition, litigation, regulatory approvals, and market sentiment. Provisions in Delaware law, the company's charter, and agreements could prevent or delay a change of control. As a Public Benefit Corporation (PBC), directors must balance shareholder interests with public benefit, potentially affecting takeover decisions and increasing litigation risk. Shareholders rely solely on stock appreciation for returns, as the company does not intend to pay cash dividends - The price of the company's common stock can be highly volatile due to various factors, including financial results, clinical trial outcomes, competition, litigation, regulatory announcements, and market sentiment[254](index=254&type=chunk)[258](index=258&type=chunk) - Provisions of Delaware law, the company's charter, bylaws, and certain employment and license agreements could prevent or delay a change of control or change in management[255](index=255&type=chunk)[257](index=257&type=chunk) - As a Delaware Public Benefit Corporation (PBC), directors are obligated to balance the financial interests of shareholders with the interests of stakeholders and the pursuit of the public benefit purpose, which may affect decisions regarding takeover offers and could increase litigation risk[262](index=262&type=chunk)[264](index=264&type=chunk) - The company has never paid and does not intend to pay cash dividends, meaning shareholders must rely on stock appreciation for any return on their investment[259](index=259&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the nine months ended September 30, 2023, the company did not repurchase any outstanding equity securities nor sell any equity securities in unregistered transactions - During the nine months ended September 30, 2023, the company did not repurchase any of its outstanding equity securities[265](index=265&type=chunk) - During the nine months ended September 30, 2023, the company did not sell any equity securities in transactions that were not registered under the Securities Act of 1933, as amended[265](index=265&type=chunk) [Item 5. Other Information](index=52&type=section&id=Item%205.%20Other%20Information) This section discloses that Dr. Martine Rothblatt, Chairperson and CEO, adopted a Rule 10b5-1(c) trading plan on August 4, 2023, to exercise and sell up to 723,869 stock options between November 2023 and August 2024. She also beneficially owns 644,479 shares of common stock and vested options for 2,527,340 shares - Dr. Martine Rothblatt, Chairperson and Chief Executive Officer, adopted a Rule 10b5-1(c) trading plan on August 4, 2023, to exercise up to **723,869 stock options** and sell the shares between November 6, 2023, and August 31, 2024[266](index=266&type=chunk) - As of October 25, 2023, Dr. Rothblatt beneficially owns **644,479 shares** of common stock and vested options to purchase **2,527,340 shares** of common stock[267](index=267&type=chunk) [Item 6. Exhibits](index=53&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, a specialty pharmacy network agreement, certifications from executive officers, and financial information formatted in iXBRL - Key exhibits include the Restated Certificate of Incorporation, Tenth Amended and Restated Bylaws, Fifth Amendment to Specialty Pharmacy Network Agreement, Certifications of Principal Executive and Financial Officers (pursuant to Rule 13a-14(a) and Section 906), and financial information formatted in Inline Extensible Business Reporting Language (iXBRL)[269](index=269&type=chunk) [Signatures](index=54&type=section&id=SIGNATURES) This section contains the required signatures for the Quarterly Report on Form 10-Q

United Therapeutics Corporation (NASDAQ:UTHR) Q2 2023 Earnings Conference Call August 2, 2023 9:00 AM ET Company Participants Dewey Steadman - Head-Investor Relations Martine Rothblatt - Chairperson & Chief Executive Officer Michael Benkowitz - President & Chief Operating Officer James Edgemond - Chief Financial Officer & Treasurer Leigh Peterson - Senior Vice President of Product Development Conference Call Participants Ash Verma - UBS Eun Yang - Jefferies Hartaj Singh - Oppenheimer Terence Flynn - Morgan ...

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, 2023 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 52-198474 ...

United Therapeutics Corporation (NASDAQ:UTHR) Q1 2023 Earnings Conference Call May 3, 2023 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 Pat Poisson - Executive Vice President of Technical Operations Leigh Peterson - Senior Vice President of Product Development Conference Call Participants Joseph Thome - TD Cow ...

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 March 31, 2023 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 52-19847 ...

United Therapeutics Corporation (NASDAQ:UTHR) Q4 2022 Earnings Conference Call February 22, 2023 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 of Product Development Pat Poisson - Executive Vice President of Technical Operations Conference Call Participants Jessica Fye - J ...