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(1) Net product sales include both the drug product and the respective inhalation device.
(2) Net product sales include sales of infusion devices including the Remunity Pump.
Gross-to-Net Deductions
We recognize revenues net of: (1) rebates and chargebacks; (2) prompt pay discounts; (3) allowance for sales returns; and (4) distributor fees. These are referred to as gross-to-net deductions and are primarily based on estimates reflecting historical experiences as well as contractual and statutory requirements. We currently estimate our allowance for sales returns using reports from our distributors. The tables below include a reconciliation of the liability accounts associated with these deductions (in millions):
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| | Year Ended December 31, 2023 |
| | Rebates & Chargebacks | | Prompt Pay Discounts | | Allowance for Sales Returns | | Distributor Fees | | Total |
| Balance, January 1, 2023 | | $ | 81.3 | | | $ | 4.4 | | | $ | 3.3 | | | $ | 10.9 | | | $ | 99.9 | |
| Provisions attributed to sales in: | | | | | | | | | | |
| Current period | | 278.0 | | | 52.5 | | | 1.3 | | | 40.7 | | | 372.5 | |
| Prior periods | | (2.5) | | | (0.1) | | | (1.9) | | | (0.9) | | | (5.4) | |
| Payments or credits attributed to sales in: | | | | | | | | | | |
| Current period | | (169.8) | | | (47.3) | | | — | | | (30.3) | | | (247.4) | |
| Prior periods | | (78.6) | | | (4.2) | | | (0.8) | | | (10.0) | | | (93.6) | |
| Balance, December 31, 2023 | | $ | 108.4 | | | $ | 5.3 | | | $ | 1.9 | | | $ | 10.4 | | | $ | 126.0 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Year Ended December 31, 2022 |
| | Rebates & Chargebacks | | Prompt Pay Discounts | | Allowance for Sales Returns | | Distributor Fees | | Total |
| Balance, January 1, 2022 | | $ | 67.8 | | | $ | 3.8 | | | $ | 6.3 | | | $ | 7.9 | | | $ | 85.8 | |
| Provisions attributed to sales in: | | | | | | | | | | |
| Current period | | 202.8 | | | 43.2 | | | 2.3 | | | 34.5 | | | 282.8 | |
| Prior periods | | (4.3) | | | (0.5) | | | (3.1) | | | 0.5 | | | (7.4) | |
| Payments or credits attributed to sales in: | | | | | | | | | | |
| Current period | | (121.1) | | | (38.9) | | | (0.7) | | | (23.6) | | | (184.3) | |
| Prior periods | | (63.9) | | | (3.2) | | | (1.5) | | | (8.4) | | | (77.0) | |
| Balance, December 31, 2022 | | $ | 81.3 | | | $ | 4.4 | | | $ | 3.3 | | | $ | 10.9 | | | $ | 99.9 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Year Ended December 31, 2021 |
| | Rebates & Chargebacks | | Prompt Pay Discounts | | Allowance for Sales Returns | | Distributor Fees | | Total |
| Balance, January 1, 2021 | | $ | 65.3 | | | $ | 3.0 | | | $ | 12.5 | | | $ | 3.7 | | | $ | 84.5 | |
| Provisions attributed to sales in: | | | | | | | | | | |
| Current period | | 217.0 | | | 38.5 | | | — | | | 31.3 | | | 286.8 | |
| Prior periods | | 1.6 | | | — | | | (3.9) | | | 0.2 | | | (2.1) | |
| Payments or credits attributed to sales in: | | | | | | | | | | |
| Current period | | (151.8) | | | (34.7) | | | — | | | (22.4) | | | (208.9) | |
| Prior periods | | (64.3) | | | (3.0) | | | (2.3) | | | (4.9) | | | (74.5) | |
| Balance, December 31, 2021 | | $ | 67.8 | | | $ | 3.8 | | | $ | 6.3 | | | $ | 7.9 | | | $ | 85.8 | |
Cost of Sales
The table below summarizes cost of sales by major category (dollars in millions):
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| Year Ended December 31, | | Dollar Change | | Percentage Change |
| 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Category: | | | | | | | | | | | | | |
| Cost of sales | $ | 255.1 | | | $ | 146.7 | | | $ | 116.7 | | | $ | 108.4 | | | $ | 30.0 | | | 74 | % | | 26 | % |
Share-based compensation expense(1) | 2.4 | | | 4.9 | | | 5.8 | | | (2.5) | | | (0.9) | | | (51) | % | | (16) | % |
| Total cost of sales | $ | 257.5 | | | $ | 151.6 | | | $ | 122.5 | | | $ | 105.9 | | | $ | 29.1 | | | 70 | % | | 24 | % |
(1)See Share-Based Compensation section below for discussion.
Cost of sales, excluding share-based compensation. The increase in cost of sales for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to an increase in Tyvaso DPI royalty expense and product costs, following its commercial launch in June 2022, and an increase in Remunity product sales.
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58 | United Therapeutics, a public benefit corporation |
Research and Development
The table below summarizes the nature of research and development expense by major expense category (dollars in millions):
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| Year Ended December 31, | | Dollar Change | | Percentage Change |
| | 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Category: | | | | | | | | | | | | | |
External research and development(1) | $ | 192.0 | | | $ | 168.8 | | | $ | 156.7 | | | $ | 23.2 | | | $ | 12.1 | | | 14 | % | | 8 | % |
Internal research and development(2) | 146.6 | | | 131.4 | | | 117.2 | | | 15.2 | | | 14.2 | | | 12 | % | | 12 | % |
Share-based compensation expense(3) | 15.6 | | | 23.8 | | | 24.4 | | | (8.2) | | | (0.6) | | | (34) | % | | (2) | % |
Impairments(4) | — | | | — | | | 130.0 | | | — | | | (130.0) | | | — | % | | (100) | % |
Other(5) | 53.8 | | | (1.1) | | | 111.8 | | | 54.9 | | | (112.9) | | | NM(6) | | (101) | % |
| Total research and development expense | $ | 408.0 | | | $ | 322.9 | | | $ | 540.1 | | | $ | 85.1 | | | $ | (217.2) | | | 26 | % | | (40) | % |
(1)External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product.
(2)Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities.
(3)See Share-Based Compensation section below for discussion.
(4)Impairments primarily includes impairment charges to write down the carrying value of in-process research and development (IPR&D) and of certain property, plant, and equipment as a result of research and development activities. During the years ended December 31, 2023, 2022, and 2021, we recorded impairment charges of zero, zero, and $130.0 million, respectively.
(5)Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, costs to acquire certain IPR&D assets, and a one-time expense associated with the redemption of a pediatric disease priority review voucher in 2021. During the year ended December 31, 2023, we recorded $46.0 million in IPR&D expense in connection with the acquisition of IVIVA Medical, Inc. (IVIVA).
(6)Calculation is not meaningful.
Research and development, excluding share-based compensation. The increase in research and development expense for the year ended December 31, 2023, as compared to the same period in 2022, was due to: (1) an increase in IPR&D expense in connection with the acquisition of IVIVA; (2) increased expenditures related to the TETON 1 and TETON 2 clinical studies of nebulized Tyvaso in patients with IPF; and (3) increased expenditures related to organ manufacturing projects.
Selling, General, and Administrative
The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
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| Year Ended December 31, | | Dollar Change | | Percentage Change |
| | 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Category: | | | | | | | | | | | | | |
| General and administrative | $ | 374.2 | | | $ | 333.2 | | | $ | 294.3 | | | $ | 41.0 | | | $ | 38.9 | | | 12 | % | | 13 | % |
| Sales and marketing | 81.8 | | | 70.8 | | | 64.4 | | | 11.0 | | | 6.4 | | | 16 | % | | 10 | % |
Share-based compensation expense(1) | 21.1 | | | 78.1 | | | 108.3 | | | (57.0) | | | (30.2) | | | (73) | % | | (28) | % |
| Total selling, general, and administrative expense | $ | 477.1 | | | $ | 482.1 | | | $ | 467.0 | | | $ | (5.0) | | | $ | 15.1 | | | (1) | % | | 3 | % |
(1)See Share-Based Compensation section below for discussion.
General and administrative, excluding share-based compensation. The increase in general and administrative expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to increases in: (1) office expenses; (2) personnel expense due to growth in headcount; and (3) sponsorships and grants.
Sales and marketing, excluding share-based compensation. The increase in sales and marketing expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) consulting expenses.
Share-Based Compensation
The table below summarizes share-based compensation expense by major category (dollars in millions):
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| Year Ended December 31, | | Dollar Change | | Percentage Change |
| | 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Category: | | | | | | | | | | | | | |
| Stock options | $ | 15.4 | | | $ | 22.6 | | | $ | 25.4 | | | $ | (7.2) | | | $ | (2.8) | | | (32) | % | | (11) | % |
| Restricted stock units | 52.4 | | | 35.7 | | | 24.7 | | | 16.7 | | | 11.0 | | 47 | % | | 45 | % |
| STAP awards | (30.7) | | | 46.7 | | | 86.6 | | | (77.4) | | | (39.9) | | | (166) | % | | (46) | % |
| Employee stock purchase plan | 2.0 | | | 1.8 | | | 1.8 | | | 0.2 | | | — | | | 11 | % | | — | % |
| Total share-based compensation expense | $ | 39.1 | | | $ | 106.8 | | | $ | 138.5 | | | $ | (67.7) | | | $ | (31.7) | | | (63) | % | | (23) | % |
The table below summarizes share-based compensation expense by line item in our consolidated statements of operations (dollars in millions):
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| | Year Ended December 31, | | Dollar Change | | Percentage Change |
| | 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Cost of sales | $ | 2.4 | | | $ | 4.9 | | | $ | 5.8 | | | $ | (2.5) | | | $ | (0.9) | | | (51) | % | | (16) | % |
| Research and development | 15.6 | | | 23.8 | | | 24.4 | | | (8.2) | | | (0.6) | | | (34) | % | | (2) | % |
| Selling, general, and administrative | 21.1 | | | 78.1 | | | 108.3 | | | (57.0) | | | (30.2) | | | (73) | % | | (28) | % |
| Total share-based compensation expense | $ | 39.1 | | | $ | 106.8 | | | $ | 138.5 | | | $ | (67.7) | | | $ | (31.7) | | | (63) | % | | (23) | % |
The decrease in share-based compensation expense for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to: (1) an increase in STAP benefit driven by a 21 percent decrease in our stock price during 2023, as compared to a 29 percent increase in our stock price during 2022; and (2) a decrease in stock option expense due to fewer awards remaining outstanding in 2023, as compared to the same period in 2022, partially offset by an increase in restricted stock unit expense. See Note 8—Share-Based Compensation, to our consolidated financial statements for more information.
Other (Expense) Income, Net
The change in other (expense) income, net for the year ended December 31, 2023, as compared to the same period in 2022, was primarily due to net unrealized and realized gains and losses on equity securities. See Note 4—Investments and Note 5—Fair Value Measurements, to our consolidated financial statements for more information.
Income Tax Expense
Income tax expense was $289.5 million for the year ended December 31, 2023, compared to $223.3 million for the same period in 2022. Our effective income tax rate was approximately 23 percent for the years ended December 31, 2023 and 2022. For additional details, see Note 10—Income Taxes to our consolidated financial statements.
Financial Condition, Liquidity, and Capital Resources
We have funded our operations principally through sales of our commercial products and, from time-to-time, third-party financing arrangements. We believe that our current sources of liquidity are sufficient to fund ongoing operations and future business plans as we expect aggregate growth in revenues from our commercial products. Furthermore, our customer base remains stable and we believe that it presents minimal credit risk. However, any projections of future cash flows are inherently subject to uncertainty and we may seek other forms of financing. In March 2022, we entered into a credit agreement (the 2022 Credit Agreement), which provides for unsecured revolving credit facilities of up to $2.0 billion in the aggregate. Our aggregate outstanding balance under the 2022 Credit Agreement was $700.0 million and $800.0 million as of December 31, 2023 and 2022, respectively. Although our credit facility matures in 2028, we reclassified $400.0 million of the outstanding balance as a current liability on our consolidated balance sheet as of December 31, 2023 as we intend to repay this amount within one year. See Unsecured Revolving Credit Facilities below for further details.
For information regarding the fluctuation explanations between 2022 and 2021, see our 2022 Annual Report.
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60 | United Therapeutics, a public benefit corporation |
Cash and Cash Equivalents and Marketable Investments
Cash and cash equivalents and marketable investments comprise the following (dollars in millions):
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, | | Dollar Change | | Percentage Change |
| 2023 | | 2022 | | 2023 v. 2022 | | 2023 v. 2022 |
| Cash and cash equivalents | $ | 1,207.7 | | | $ | 961.2 | | | $ | 246.5 | | | 26 | % |
| Marketable investments—current | 1,786.4 | | | 1,877.5 | | | (91.1) | | | (5) | % |
| Marketable investments—non-current | 1,909.8 | | | 1,316.2 | | | 593.6 | | | 45 | % |
| Total cash and cash equivalents and marketable investments | $ | 4,903.9 | | | $ | 4,154.9 | | | $ | 749.0 | | | 18 | % |
Cash Flows
Cash flows comprise the following (dollars in millions):
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| Year Ended December 31, | | Dollar Change | | Percentage Change |
| | 2023 | | 2022 | | 2021 | | 2023 v. 2022 | | 2022 v. 2021 | | 2023 v. 2022 | | 2022 v. 2021 |
| Net cash provided by operating activities | $ | 978.0 | | | $ | 802.5 | | | $ | 598.2 | | | $ | 175.5 | | | $ | 204.3 | | | 22 | % | | 34 | % |
| Net cash used in investing activities | $ | (719.6) | | | $ | (811.5) | | | $ | (486.9) | | | $ | 91.9 | | | $ | (324.6) | | | 11 | % | | (67) | % |
Net cash (used in) provided by financing activities | $ | (11.9) | | | $ | 75.4 | | | $ | 44.8 | | | $ | (87.3) | | | $ | 30.6 | | | (116) | % | | 68 | % |
Operating Activities
Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable, accrued expenses, liabilities for our STAP awards, and tax-related payables and receivables.
The increase of $175.5 million in net cash provided by operating activities for the year ended December 31, 2023, as compared to the year ended December 31, 2022, was primarily due to: (1) a $53.5 million decrease in cash paid to settle STAP awards; and (2) changes in other assets and liabilities.
Investing Activities
The decrease of $91.9 million in net cash used in investing activities for the year ended December 31, 2023, as compared to the year ended December 31, 2022, was primarily due to a $306.3 million decrease in cash used for total purchases, sales, and maturities of marketable investments; partially offset by: (1) a $91.6 million increase in cash paid to purchase property, plant, and equipment; (2) $89.2 million in net cash paid related to the acquisitions of IVIVA and Miromatrix; and (3) $23.0 million in deposits.
Financing Activities
The increase of $87.3 million in net cash used in financing activities for the year ended December 31, 2023, as compared to the year ended December 31, 2022, was primarily due to a $100.0 million repayment on our line of credit; partially offset by: (1) a $9.6 million increase in proceeds from the exercise of stock options; and (2) a $4.8 million decrease in payments of debt issuance costs related to the 2022 Credit Agreement.
Unsecured Revolving Credit Facilities
In March 2022, we entered into the 2022 Credit Agreement, which provides for unsecured revolving credit facilities of up to $2.0 billion in the aggregate. On March 31, 2022, we borrowed $800.0 million under the facilities and used the funds to repay outstanding indebtedness under our then-existing credit agreement (the 2018 Credit Agreement). We paid down $100.0 million of our balance under the 2022 Credit Agreement during the year ended December 31, 2023. The aggregate balance of $700.0 million under our 2022 Credit Agreement remained outstanding as of both December 31, 2023 and February 21, 2024. See Note 7—Debt, to our consolidated financial statements.
Contractual Obligations
As of December 31, 2023, we had the following contractual obligations (in millions):
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| | | Payments Due by Period |
| | | Total | | Less than 1 year | | 2-3 Years | | 4-5 Years | | More than 5 Years |
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| Operating lease obligations | | $ | 32.8 | | | $ | 4.7 | | | $ | 8.5 | | | $ | 8.1 | | | $ | 11.5 | |
Long-term debt obligations(1) | | 822.3 | | | 441.5 | | | 49.7 | | | 331.1 | | | — | |
Obligations under the STAP(2) | | 31.3 | | | 31.3 | | | — | | | — | | | — | |
Obligations under the SERP(3) | | 61.0 | | | 30.5 | | | — | | | 11.2 | | | 19.3 | |
Purchase obligations(4) | | 772.2 | | | 586.6 | | | 150.8 | | | 26.1 | | | 8.7 | |
Total(5) (6) | | $ | 1,719.6 | | | $ | 1,094.6 | | | $ | 209.0 | | | $ | 376.5 | | | $ | 39.5 | |
(1)Long-term debt obligations include future principal and interest payments on our adjusted variable rate obligations under the 2022 Credit Agreement. The 2022 Credit Agreement will mature in March 2028. As of December 31, 2023, we have classified $300.0 million of the outstanding balance as a non-current liability and $400.0 million as a current liability on our consolidated balance sheet, as we intend to repay this amount within one year. See Note 7—Debt to our consolidated financial statements for further details.
(2)Estimated based on the intrinsic value of exercisable outstanding STAP awards as of December 31, 2023. See Note 8—Share-Based Compensation—STAP Awards to our consolidated financial statements for further details.
(3)Consists of actuarially derived, undiscounted, estimated future payouts of benefits. See Note 11—Employee Benefit Plans—Supplemental Executive Retirement Plan to our consolidated financial statements for further details.
(4)Purchase obligations primarily include: (1) commitments related to research and development (including clinical trials) for new and existing products; (2) open purchase orders for capital expenditures primarily related to our continued investment in construction of additional facilities to support the development and commercialization of our products and technologies; and (3) open purchase orders for the acquisition of goods and services in the ordinary course of business. The timing and amount of our obligations may differ based on certain future events.
(5)In addition to amounts in the table above, we are contractually obligated to make payments upon the achievement of various development, regulatory, and commercial milestones for agreements we have entered into with third parties. These payments are contingent upon the occurrence of various future events, some of which have a high degree of uncertainty of occurring. These contingent payments have not been included in the table above, and, except with respect to the fair value of the contingent consideration obligations, are not recorded in our consolidated balance sheets. See Note 12—Commitments and Contingencies to our consolidated financial statements for further details.
(6)As of December 31, 2023, our other non-current liabilities in our consolidated balance sheets includes a liability of $7.0 million for unrecognized tax benefits, including related interest and penalties. Due to the high degree of uncertainty on the timing of future events that could extinguish these unrecognized tax benefits, we are unable to estimate the period of settlement and therefore we have excluded these unrecognized tax benefits from the table above. See Note 10—Income Taxes to our consolidated financial statements for further details.
Obligations Under License Agreements and Acquisition Agreements
We pay a ten percent royalty on our net sales of Tyvaso DPI under our license agreement with MannKind. Under our agreement with Arena, we will owe a low double-digit, tiered royalty on net product sales of ralinepag (any route of administration), plus certain milestone payments upon defined regulatory events. We pay Lilly a royalty equal to ten percent of our net product sales of Adcirca, as well as milestone payments of $325,000 for each $1,000,000 in Adcirca net product sales. We pay a single-digit percentage royalty based on net product sales of Orenitram under our license agreement with Supernus. We also pay The Scripps Research Institute a one percent royalty on sales of Unituxin. We have entered into other license agreements under which we are required to make milestone payments upon the achievement of certain developmental and commercialization objectives and royalty payments upon the commercialization of products covered by the license agreements. See Note 12—Commitments and Contingencies to our consolidated financial statements for further details. In addition, we may owe additional earn-out consideration to the former securityholders of IVIVA and Miromatrix, as described in Note 16—Acquisitions to our consolidated financial statements.
Off-Balance Sheet Arrangements
We hold an interest in an unconsolidated variable interest entity (VIE). We determined that we are not the primary beneficiary of this entity. As a result, we do not consolidate this VIE. See Note 4—Investments—Variable Interest Entities. We do not have any other off-balance sheet arrangements within the meaning of Item 303(a)(4) of Regulation S-K.
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62 | United Therapeutics, a public benefit corporation |
Summary of Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in conformity with generally accepted accounting principles in the United States (GAAP). GAAP requires that we make estimates and assumptions that affect the amounts and timing reported in our consolidated financial statements. As we become aware of updated information or new developments, these estimates and assumptions may change and materially impact reported amounts. We consider the following accounting policies to be critical to our consolidated financial statements because they require the use of our judgment and estimates (including those that are forward-looking) in their application.
Revenue Recognition
We generate revenues from the sale of our commercial products: Tyvaso DPI, nebulized Tyvaso, Remodulin, Orenitram, Unituxin, and Adcirca. Revenue is recognized when we transfer control of our products to our distributors, as our contracts have a single performance obligation (delivery of our product). These revenues are subject to various product sales allowances, referred to as gross-to-net deductions, which are deducted from revenues to determine net product sales. For a description of our related accounting policies, see Note 2—Summary of Significant Accounting Policies—Revenue Recognition to our consolidated financial statements.
The following category of gross-to-net deductions involves the use of significant estimates and judgments and information obtained from external sources.
Rebates and Chargebacks
Our most significant rebates relate to our participation in state Medicaid programs, contractual rebates to certain of our domestic distributors, and contractual rebates offered to managed care organizations covering Medicare Part D and commercial plans. Chargebacks relate to our participation in programs with the U.S. Department of Veterans Affairs and 340B covered entities. Although we accrue for our allowance for rebates and chargebacks in the same period that we recognize revenue, the actual rebate or chargeback on the sale of our product to a distributor is not invoiced to us until a future period, generally within six months from the date of sale. Due to this time lag, we must estimate the amount of rebates and chargebacks to accrue. As of December 31, 2023 and 2022, we had a liability of $108.4 million and $81.3 million, respectively, related to rebates and chargebacks.
Estimates associated with our participation in state Medicaid programs are particularly susceptible to adjustment given the extensive time lag that may occur between our recording of an accrual and its ultimate invoicing by individual state Medicaid programs, which can occur up to several years after the sale of our product. Because of the time lag for Medicaid and other rebates, in any particular quarter, our adjustments may incorporate revisions of accruals for prior quarters. Historically, adjustments to our estimates to reflect actual results or updated expectations have not been material to our overall financial results. Provisions attributed to sales in prior periods have been less than one percent of our total revenues for each of the years ended December 31, 2023, 2022, and 2021.
For a roll-forward of the liability accounts associated with our gross-to-net deductions, see the section above entitled Results of Operations—Gross-to-Net Deductions.
Share-Based Compensation
Our share-based awards are classified as either liabilities (STAP awards) or as equity (stock options, restricted stock units, and rights to purchase stock under our employee stock purchase plan). We recognize related share-based compensation expense based on (1) the fair value of outstanding STAP awards on the grant date and at the end of each reporting period; (2) the grant date fair value of stock options and restricted stock units; and (3) the purchase date fair value of stock under our employee stock purchase plan. With the exception of restricted stock units, we estimate the fair value of all share-based awards using the Black-Scholes-Merton valuation model. We measure the fair value of restricted stock units using the stock price on the grant date. Valuation models, like the Black-Scholes-Merton model, require the use of subjective assumptions that could materially impact the estimation of fair value and related compensation expense to be recognized. These assumptions include the expected volatility of our stock price and the expected term of awards. Developing these assumptions requires the use of judgment. For additional information on the assumptions used in the Black-Scholes-Merton valuation model, see Note 8—Share-Based Compensation, to our consolidated financial statements.
Recently Issued Accounting Standards
See Note 3—Recently Issued Accounting Standards, to our consolidated financial statements for information on our anticipated adoption of recently issued accounting standards.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Investment Risk
As of December 31, 2023, we have invested $3.8 billion in corporate debt securities and U.S. government and agency securities. The market value of these investments varies inversely with changes in prevailing market interest rates. In general, as interest rates increase, the market value of a debt investment would be expected to decrease. Conversely, as interest rates decrease, the market value of a debt investment would be expected to increase. During 2023, we experienced significant volatility in the value of these investments as a direct result of the current interest rate environment. To address market risk, we invest in debt securities with terms no longer than three years and typically hold these investments to maturity so that they can be redeemed at their stated or face value. Many of our investments may be called by their respective issuers prior to maturity. The following table summarizes the expected maturities and weighted average interest rates as of December 31, 2023 (dollars in millions):
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| Expected Maturity |
| 2024 | | 2025 | | 2026 |
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Common stock, par value $, shares authorized, and shares issued, and and shares outstanding as of December 31, 2023 and 2022, respectively | | | | | |
| Additional paid-in capital | | | | | |
| Accumulated other comprehensive loss | () | | | () | |
Treasury stock, shares as of December 31, 2023 and 2022 | () | | | () | |
| Retained earnings | | | | | |
| Total stockholders’ equity | | | | | |
| Total liabilities and stockholders’ equity | $ | | | | $ | | |
See accompanying notes to consolidated financial statements.
Consolidated Statements of Operations
(In millions, except per share data)
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| Year Ended December 31, |
| 2023 | | 2022 | | 2021 |
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| Total revenues | $ | | | | $ | | | | $ | | |
| Operating expenses: | | | | | |
| Cost of sales | | | | | | | | |
| Research and development | | | | | | | | |
| Selling, general, and administrative | | | | | | | | |
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| Total operating expenses | | | | | | | | |
| Operating income | | | | | | | | |
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| Interest income | | | | | | | | |
| Interest expense | () | | | () | | | () | |
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| Other (expense) income, net | () | | | () | | | | |
| Impairments of investments in privately-held companies | | | | () | | | () | |
Total other income (expense), net | | | | () | | | | |
| Income before income taxes | | | | | | | | |
| Income tax expense | () | | | () | | | () | |
| Net income | $ | | | | $ | | | | $ | | |
| Net income per common share: | | | | | |
| Basic | $ | | | | $ | | | | $ | | |
| Diluted | $ | | | | $ | | | | $ | | |
| Weighted average number of common shares outstanding: | | | | | |
| Basic | | | | | | | | |
| Diluted | | | | | | | | |
See accompanying notes to consolidated financial statements.
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F-6 | United Therapeutics, a public benefit corporation |
Consolidated Statements of Comprehensive Income
(In millions)
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| | Year Ended December 31, |
| | 2023 | | 2022 | | 2021 |
| Net income | $ | | | | $ | | | | $ | | |
| Other comprehensive income (loss): | | | | | |
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| Defined benefit pension plan: | | | | | |
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| Actuarial gain arising during period, net of tax | | | | | | | | |
Actuarial gain and prior service cost included in net periodic pension cost and settlement, net of tax | () | | | | | | | |
| Total defined benefit pension plan, net of tax | () | | | | | | | |
| Unrealized gain (loss) on available-for-sale securities, net of tax | | | | () | | | () | |
| Other comprehensive income (loss), net of tax | | | | () | | | () | |
| Comprehensive income | $ | | | | $ | | | | $ | | |
During the years ended December 31, 2023, 2022, and 2021, the tax (benefit) expense in other comprehensive income was $() million, $ million, and $ million, respectively, for the defined benefit pension plan and $ million, $() million, and $() million, respectively, for the available-for-sale securities.
See accompanying notes to consolidated financial statements.
Consolidated Statements of Stockholders’ Equity
(In millions)
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| | Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Loss | | Treasury Stock | | Retained Earnings | | Stockholders’ Equity |
| | Shares | | Amount | |
| Balance, December 31, 2020 | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | | | | $ | | |
| Net income | — | | | — | | | — | | | — | | | — | | | | | | | |
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| Unrealized losses on available-for-sale securities | — | | | — | | | — | | | () | | | — | | | — | | | () | |
| Defined benefit pension plan | — | | | — | | | — | | | | | | — | | | — | | | | |
Shares issued under employee stock purchase plan (ESPP) | | | | — | | | | | | — | | | — | | | — | | | | |
Common stock issued for restricted stock units (RSUs) vested | | | | — | | | — | | | — | | | — | | | — | | | — | |
| RSUs withheld for taxes | — | | | — | | | () | | | — | | | — | | | — | | | () | |
| Exercise of stock options | | | | — | | | | | | — | | | — | | | — | | | | |
| Share-based compensation | — | | | — | | | | | | — | | | — | | | — | | | | |
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| Balance, December 31, 2021 | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | | | | $ | | |
| Net income | — | | | — | | | — | | | — | | | — | | | | | | | |
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| Unrealized losses on available-for-sale securities | — | | | — | | | — | | | () | | | — | | | — | | | () | |
| Defined benefit pension plan | — | | | — | | | — | | | | | | — | | | — | | | | |
| Shares issued under ESPP | | | | — | | | | | | — | | | — | | | — | | | | |
Common stock issued for RSUs vested | | | | — | | | — | | | — | | | — | | | — | | | — | |
| RSUs withheld for taxes | — | | | — | | | () | | | — | | | — | | | — | | | () | |
| Exercise of stock options | | | | — | | | | | | — | | | — | | | — | | | | |
| Share-based compensation | — | | | — | | | | | | — | | | — | | | — | | | | |
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| Balance, December 31, 2022 | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | | | | $ | | |
| Net income | — | | | — | | | — | | | — | | | — | | | | | | | |
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Unrealized gains on available-for-sale securities | — | | | — | | | — | | | | | | — | | | — | | | | |
| Defined benefit pension plan | — | | | — | | | — | | | () | | | — | | | — | | | () | |
| Shares issued under ESPP | — | | | — | | | | | | — | | | — | | | — | | | | |
Common stock issued for RSUs vested | | | | — | | | — | | | — | | | — | | | — | | | — | |
| RSUs withheld for taxes | — | | | — | | | () | | | — | | | — | | | — | | | () | |
| Exercise of stock options | | | | — | | | | | | — | | | — | | | — | | | | |
| Share-based compensation | — | | | — | | | | | | — | | | — | | | — | | | | |
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| Balance, December 31, 2023 | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | | | | $ | | |
See accompanying notes to consolidated financial statements.
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F-8 | United Therapeutics, a public benefit corporation |
Consolidated Statements of Cash Flows
(In millions)
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| | Year Ended December 31, |
| | 2023 | | 2022 | | 2021 |
| Cash flows from operating activities: | | | | | |
| Net income | $ | | | | $ | | | | $ | | |
| Adjustments to reconcile net income to net cash provided by operating activities: | | | | | |
| Depreciation and amortization | | | | | | | | |
| Share-based compensation expense | | | | | | | | |
| Impairments of investments in privately-held companies | | | | | | | | |
| Impairments of property, plant, and equipment | | | | | | | | |
| Intangible asset impairment charges | | | | | | | | |
| Realized gain on sale of investment in privately-held company | | | | () | | | | |
| Realized gain on sale of equity securities | | | | () | | | () | |
| Other | () | | | | | | | |
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| Changes in operating assets and liabilities: | | | | | |
| Accounts receivable | () | | | () | | | () | |
| Inventories | () | | | () | | | () | |
| Accounts payable and accrued expenses | | | | | | | () | |
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| Other assets and liabilities | () | | | () | | | () | |
| Net cash provided by operating activities | | | | | | | | |
| Cash flows from investing activities: | | | | | |
| Purchases of property, plant, and equipment | () | | | () | | | () | |
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| Deposits | () | | | | | | | |
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| Purchases of available-for-sale debt securities | () | | | () | | | () | |
| Maturities of available-for-sale debt securities | | | | | | | | |
| Sales of available-for-sale debt securities | | | | | | | | |
| Sales of investments in equity securities | | | | | | | | |
| Sale of investment in privately-held company | | | | | | | | |
| Proceeds from note receivable | | | | | | | | |
| Purchase of investment in privately-held company | | | | () | | | | |
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Acquisitions, net of cash acquired | () | | | | | | | |
| Net cash used in investing activities | () | | | () | | | () | |
| Cash flows from financing activities: | | | | | |
| Proceeds from line of credit | | | | | | | | |
| Repayment of line of credit | () | | | () | | | | |
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| Payments of debt issuance costs | () | | | () | | | | |
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| Proceeds from the exercise of stock options | | | | | | | | |
| Proceeds from the issuance of stock under ESPP | | | | | | | | |
| RSUs withheld for taxes | () | | | () | | | () | |
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Net cash (used in) provided by financing activities | () | | | | | | | |
| Net increase in cash and cash equivalents | $ | | | | $ | | | | $ | | |
| Cash and cash equivalents, beginning of year | | | | | | | | |
| Cash and cash equivalents, end of year | $ | | | | $ | | | | $ | | |
| Supplemental cash flow information: | | | | | |
| Cash paid for interest | $ | | | | $ | | | | $ | | |
| Cash paid for income taxes | $ | | | | $ | | | | $ | | |
| Non-cash investing and financing activities: | | | | | |
| Non-cash additions to property, plant, and equipment | $ | | | | $ | | | | $ | | |
| Receivable from maturity of available-for-sale debt securities | $ | | | | $ | | | | $ | | |
|
See accompanying notes to consolidated financial statements.
Notes to Consolidated Financial Statements
1.
2.
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F-10 | United Therapeutics, a public benefit corporation |
| | $ | | |
| Work-in-progress | | | | | |
| Finished goods | | | | | |
| Total inventories | $ | | | | $ | | |
t result in any impairment losses. Indefinite-lived intangible assets are not amortized but are evaluated annually or more frequently for impairment if impairment indicators exist. Our indefinite-lived intangible assets include purchased in-process research and development (IPR&D) assets, which were measured at their estimated fair values as of their acquisition dates. There were impairment losses related to indefinite-lived intangible assets during the years ended December 31, 2023 and December 31, 2022. During the year ended December 31, 2021, we recognized IPR&D impairment charges of $ million related to our decision to discontinue the U.S. development of Trevyent® and our decision to discontinue our research and development efforts related to biomechanical lungs.
We recorded impairment losses during the years ended December 31, 2023, 2022, and 2021 related to intangible assets subject to amortization.
| | $ | — | | | $ | | | | $ | | | | $ | — | | | $ | | | | Other intangible assets: | | | | | | | | | | | |
| In-process research and development | | | | — | | | | | | | | | — | | | | |
Other | | | | () | | | | | | | | | () | | | | |
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| Total accounts payable and accrued expenses | $ | | | | $ | | |
7.
billion; and (2) a second unsecured revolving credit facility of up to $ million (which facilities may, at our request, be increased by up to $ million in the aggregate subject to obtaining commitments from existing or new lenders for such increase and other conditions). In accordance with the terms of the 2022 Credit Agreement, in March 2023, we extended the maturity date of the 2022 Credit Agreement by , to March 2028. The lenders may extend the maturity date by one additional year to March 2029 if we request such an extension.At our option, amounts borrowed under the 2022 Credit Agreement bear interest at either an adjusted Term Secured Overnight Finance Rate (Term SOFR) or a fluctuating base rate, in each case, plus an applicable margin determined on a quarterly basis based on our consolidated ratio of total indebtedness to EBITDA (as calculated in accordance with the 2022 Credit Agreement). To date, we have elected to calculate interest on the outstanding balance at an adjusted Term SOFR plus an applicable margin.
On March 31, 2022, we borrowed $ million under the 2022 Credit Agreement, and used the funds to repay outstanding indebtedness under the 2018 Credit Agreement as discussed below under 2018 Credit Agreement.
As of December 31, 2022, our outstanding aggregate principal balance under the 2022 Credit Agreement was $ million. During the year ended December 31, 2023, we paid down $ million of our balance under the 2022 Credit Agreement, which brought our aggregate outstanding balance down to $ million as of December 31, 2023. Although our credit facility matures in 2028, we reclassified $ million of the outstanding balance as a current liability on our consolidated balance sheet as of December 31, 2023, as we intend to repay this amount within one year.
The 2022 Credit Agreement contains customary events of default and customary affirmative and negative covenants. As of December 31, 2023, we were in compliance with these covenants.
The interest expense reported in our consolidated statements of operations for each of the years ended December 31, 2023, 2022, and 2021, related to our borrowings under the 2022 Credit Agreement and 2018 Credit Agreement.
2018 Credit Agreement
In June 2018, we entered into a credit agreement (the 2018 Credit Agreement) with Wells Fargo, as administrative agent and a swingline lender, and various other lender parties, providing for: (1) an unsecured revolving credit facility of up to $ billion; and (2) a second unsecured revolving credit facility of up to $ million.
8.
shareholder-approved equity incentive plans: the United Therapeutics Corporation Amended and Restated Equity Incentive Plan (the 1999 Plan) and the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (as amended to date, the 2015 Plan). The 2015 Plan provides for the issuance of up to shares of our common stock pursuant to awards granted under the 2015 Plan, which includes shares added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2023. further awards will be granted under the 1999 Plan. We also have equity incentive plan, the United Therapeutics Corporation 2019 Inducement Stock Incentive Plan (the 2019 Inducement Plan), that has not been approved by our shareholders, as permitted by the Nasdaq Stock Market rules. The 2019 Inducement Plan was approved by our Board of Directors in February 2019 and provides for the issuance of up to shares of our common stock under awards granted to newly-hired employees. Currently, we grant equity-based awards to employees and members of our Board of Directors in the form of stock options and restricted stock units (RSUs) under the 2015 Plan, and we may grant RSUs to newly-hired employees under the 2019 Inducement Plan. See the sections entitled Stock Options and RSUs below for additional information regarding these equity-based awards.In March 2023, we issued stock options and RSUs to certain executives with vesting conditions tied to the achievement of specified performance criteria through the end of 2025. Throughout the performance period, we reassess the estimated performance and update the number of performance-based awards that we believe will ultimately vest. Estimating future performance requires the use of judgment. Upon the conclusion of the performance period, the performance level achieved and the ultimate number of options or shares, as applicable, that vest are determined. Share-based compensation expense for these awards is recorded ratably over their vesting period, depending on the specific terms of the award and anticipated achievement of the specified performance criteria.
We previously issued awards under the United Therapeutics Corporation 2011 Share Tracking Awards Plan (the STAP). We refer to awards outstanding under the STAP as STAP awards. See the section entitled STAP Awards below for additional information regarding STAP awards. We discontinued the issuance of STAP awards in June 2015.
In 2012, our shareholders approved the United Therapeutics Corporation Employee Stock Purchase Plan (ESPP), which is structured to comply with Section 423 of the Internal Revenue Code. See the section entitled ESPP below for additional information regarding the ESPP.
| | $ | | | | $ | | | | RSUs | | | | | | | | |
| STAP awards | () | | | | | | | |
| ESPP | | | | | | | | |
| Total share-based compensation expense before tax | $ | | | | $ | | | | $ | | |
| Share-based compensation capitalized as part of inventory | $ | | | | $ | | | | $ | | |
Stock Options
We estimate the fair value of stock options using the Black-Scholes-Merton valuation model, which requires us to make certain assumptions that can materially impact the estimation of fair value and related compensation expense. The assumptions used to estimate fair value include the price of our common stock, the expected volatility of our common stock, the risk-free interest rate, the expected term of stock option awards, and the expected dividend yield.
During the year ended December 31, 2023, in addition to time-based stock options, we granted million performance-based stock options with a total grant date fair value of $ million, calculated based on the assumed achievement of maximum performance of the relevant financial performance condition. During the year ended December 31, 2023, we recorded $ million of share-based compensation expense related to performance-based stock options, calculated based on the assumed level of performance achievement.
A description of the key inputs, requiring estimates, used in determining the fair value of stock options are provided below:
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F-22 | United Therapeutics, a public benefit corporation |
. We believe that the volatility in the price of our common stock over the preceding generally provides a reliable projection of future long-term volatility.Risk-free interest rate—The risk-free interest rate is the average interest rate consistent with the yield available on a U.S. Treasury note with a term equal to the expected term of an award.
Expected dividend yield—We do not pay cash dividends on our common stock and do not expect to do so in the future. Therefore, the dividend yield is .
| | | | | Expected volatility | | % | | | % | | | % |
| Risk-free interest rate | | % | | | % | | | % |
| Expected dividend yield | | % | | | % | | | % |
| | $ | | | | | | | | Granted | | | | | | | | | |
| Exercised | () | | | | | | | | |
| Forfeited | | | | | | | | | |
| Outstanding as of December 31, 2023 | | | | $ | | | | | | $ | | |
| Exercisable as of December 31, 2023 | | | | $ | | | | | | $ | | |
| Unvested as of December 31, 2023 | | | | $ | | | | | | $ | | |
The weighted average fair value of a stock option granted during each of the years in the three-year period ended December 31, 2023, was $, $, and $, respectively. The total fair value of stock options that vested for each of the years in the three-year period ended December 31, 2023, was $ million, $ million, and $ million, respectively.
| | $ | | | | $ | | | | Research and development | | | | | | | | |
| Selling, general, and administrative | | | | | | | | |
| Share-based compensation expense before taxes | | | | | | | | |
| Related income tax benefit | () | | | () | | | () | |
| Share-based compensation expense, net of taxes | $ | | | | $ | | | | $ | | |
| As of December 31, 2023, unrecognized compensation cost relating to stock options was $ million. Unvested outstanding stock options as of December 31, 2023 had a weighted average remaining vesting period of years.
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| Cash received from options exercised | $ | | | | $ | | | | $ | | |
| Total intrinsic value of options exercised | $ | | | | $ | | | | $ | | |
Tax benefits realized from options exercised(1) | $ | | | | $ | | | | $ | | |
(1)We recognize these tax benefits in our consolidated statements of operations within income tax expense.
RSUs
We issue RSUs to employees and non-employee directors. Each RSU entitles the recipient to share of our common stock upon vesting. We measure the fair value of RSUs using the stock price on the date of grant. Share-based compensation expense for RSUs is recorded ratably over their vesting period.
During the year ended December 31, 2023, in addition to time-based RSUs, we granted million performance-based RSUs with a total grant date fair value of $ million, calculated based on the assumed achievement of maximum performance of the relevant financial and non-financial performance conditions. During the year ended December 31, 2023, we recorded $ million of share-based compensation expense related to performance-based RSUs, calculated based on the assumed levels of performance achievement.
| | $ | | | | Granted | | | | | |
| Vested | () | | | | |
| Forfeited | () | | | | |
| Unvested as of December 31, 2023 | | | | $ | | |
| | $ | | | | $ | | | | Research and development | | | | | | | | |
| Selling, general, and administrative | | | | | | | | |
| Share-based compensation expense before taxes | | | | | | | | |
| Related income tax benefit | () | | | () | | | () | |
| Share-based compensation expense, net of taxes | $ | | | | $ | | | | $ | | |
| As of December 31, 2023, unrecognized compensation cost related to the grant of RSUs was $ million. Unvested outstanding RSUs as of December 31, 2023 had a weighted average remaining vesting period of years.
STAP Awards
STAP awards convey the right to receive in cash an amount equal to the appreciation of our common stock, which is measured as the increase in the closing price of our common stock between the dates of grant and exercise. STAP awards expire on the tenth anniversary of the grant date, and in most cases, they vest in equal increments on each anniversary of the grant date over a period. We discontinued the issuance of STAP awards in June 2015.
The aggregate liability balance associated with outstanding STAP awards was $ million and $ million as of December 31, 2023 and 2022, respectively, all of which was classified as a current liability in our consolidated balance sheets.
Estimating the fair value of STAP awards requires the use of certain inputs that can materially impact the determination of fair value and the amount of compensation expense (benefit) we recognize. Inputs used in estimating fair value include the price
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F-24 | United Therapeutics, a public benefit corporation |
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| Expected volatility | | % | | | % | | | % |
| Risk-free interest rate | | % | | | % | | | % |
| Expected dividend yield | | % | | | % | | | % |
The closing price of our common stock was $, $, and $ on December 31, 2023, 2022, and 2021, respectively.
| | $ | | | | | | | | Granted | | | | | | | | | |
| Exercised | () | | | | | | | | |
| Forfeited | () | | | | | | | | |
| Outstanding as of December 31, 2023 | | | | $ | | | | | | $ | | |
| Exercisable as of December 31, 2023 | | | | $ | | | | | | $ | | |
| Unvested as of December 31, 2023 | — | | | $ | — | | | — | | | $ | — | |
) | | $ | | | | $ | | | | Research and development | () | | | | | | | |
| Selling, general, and administrative | () | | | | | | | |
| Share-based compensation (benefit) expense before taxes | () | | | | | | | |
| Related income tax expense (benefit) | | | | () | | | () | |
| Share-based compensation (benefit) expense, net of taxes | $ | () | | | $ | | | | $ | | |
Cash paid to settle STAP awards exercised during the years ended December 31, 2023, 2022, and 2021 was $ million, $ million, and $ million, respectively.
ESPP
In June 2012, our shareholders approved the ESPP, which is structured to comply with Section 423 of the Internal Revenue Code. The ESPP provides eligible employees with the right to purchase shares of our common stock at a discount through elective accumulated payroll deductions at the end of each offering period. Offering periods, which began in 2012, occur in consecutive periods commencing on September 5th and March 5th of each year. Eligible employees may contribute up to percent of their base salary, subject to certain annual limitations as defined in the ESPP. The purchase price of the shares is equal to the lower of percent of the closing price of our common stock on either the first or last trading day of a given offering period. In addition, the ESPP provides that no eligible employee may purchase more than
shares during any offering period. The ESPP has a term and limits the aggregate number of shares that can be issued under the ESPP to million.9.
| | $ | | | | $ | | | | Denominator: | | | | | |
| Weighted average outstanding shares — basic | | | | | | | | |
Effect of dilutive securities(1): | | | | | |
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(1) Net product sales include both the drug product and the respective inhalation device.
(2) Net product sales include sales of infusion devices including the Remunity Pump.
% | | | % | | | % |
| Distributor 2 | | % | | | % | | | % |
| Distributor 3 | | % | | | % | | | % |
| | $ | | | | $ | | | | Rest-of-World | | | | | | | | |
| Total | $ | | | | $ | | | | $ | | |
14.
million, disclosed and made available to the plaintiffs certain specifications and other information related to the MS-3 cartridges, and granted to the plaintiffs a non-exclusive, royalty-free license in the United States to Smiths Medical’s patents and copyrights associated with the MS-3 cartridges and certain other information related to the MS-3 pumps and cartridges.In March 2022, the court granted our motion for summary judgment with respect to all claims brought by the plaintiffs except the breach of contract claim. As a result, all antitrust claims, all claims under state competition laws, and the common law
petitions for inter partes review (IPR) with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). In its petitions, Liquidia sought to invalidate U.S. Patent Nos. 9,604,901 (the ’901 patent) and 9,593,066 (the ’066 patent), both of which relate to a method of making treprostinil, the active pharmaceutical ingredient in Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram. These patents were issued in March 2017 and are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book, for Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram. In October 2020, the PTAB declined to institute IPR proceedings on the ’066 patent because Liquidia failed to establish a reasonable likelihood of prevailing on any claim relating to the ’066 patent. The PTAB instituted IPR proceedings on the ’901 patent in October 2020 and issued a final written decision in October 2021. The final written decision found that Liquidia had proven the invalidity of of the claims of the ‘901 patent but failed to prove the invalidity of other claims. The parties have each appealed portions of the final written decision adverse to them, and those appeals are pending. No cancellation of claims takes effect until resolution of any appeals.In January 2020, Liquidia submitted an NDA to the FDA for approval of Yutrepia™, a dry powder inhalation formulation of treprostinil, to treat PAH. This NDA was submitted under the 505(b)(2) regulatory pathway with nebulized Tyvaso as the reference listed drug. In November 2021, the FDA granted tentative approval of Liquidia’s NDA.
In April 2020, we received a Paragraph IV Certification Notice Letter (Notice Letter) from Liquidia, stating that it intends to market Yutrepia before the expiration of all patents listed in the Orange Book for nebulized Tyvaso. The Notice Letter stated that Liquidia’s NDA for Yutrepia contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Yutrepia.
In June 2020, we filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia for infringement of the ’901 patent and the ’066 patent, both of which expire in December 2028. We filed our lawsuit within days of receipt of notice from Liquidia of its NDA filing. As a result, under the Hatch-Waxman Act, the FDA was precluded by regulation from approving Liquidia’s NDA for up to months or until the resolution of the litigation, whichever occurs first. In July 2020, Liquidia filed an answer to our complaint that included counterclaims alleging, among other things, that the patents at issue in the litigation are not valid and will not be infringed by the commercial manufacture, use, or sale of Yutrepia.
In July 2020, the USPTO issued a new patent to us related to Tyvaso. The new patent, U.S. Patent No. 10,716,793 (the ’793 patent), expires in May 2027, and is listed in the Orange Book for Tyvaso DPI and nebulized Tyvaso. In July 2020, we filed an amended complaint against Liquidia to include a claim for infringement of the ’793 patent. The ’793 patent relates to a method of administering treprostinil via inhalation and includes claims covering the dosing regimen used to administer Tyvaso DPI and nebulized Tyvaso. In December 2021, we filed a stipulation that the ’901 patent would not be infringed by Liquidia based on the court’s claim construction ruling.
Trial took place during March 2022, and the court issued its decision in August 2022. The court found that Liquidia’s product would infringe the ’793 patent and that Liquidia had not proved that any claim of that patent is invalid. The court also determined that Liquidia had proved certain claims of the ’066 patent were invalid and that we had not proved Liquidia’s infringement of another ’066 patent claim. Accordingly, the court issued a final judgment that bars the FDA from approving Yutrepia until expiration of the ’793 patent in May 2027. The parties appealed portions of the decision adverse to each of them, and on July 24, 2023, the appellate court issued its decision affirming the district court decision in its entirety. The court subsequently denied the parties’ requests for rehearing, so the appellate court decision is now final. On January 23, 2024, Liquidia filed a petition for writ of certiorari seeking review by the U.S. Supreme Court, and that petition was denied on
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F-34 | United Therapeutics, a public benefit corporation |
motions to dismiss are pending with the court.We intend to vigorously defend ourselves against the claims made in this lawsuit.
Litigation with Humana and United Healthcare
Humana Inc. and United Healthcare Services, Inc. filed separate lawsuits against us in the U.S. District Court for the District of Maryland in December 2022 and November 2022, respectively. Each of these lawsuits includes allegations similar to those in the MSP Recovery matter discussed above concerning our charitable contributions to CVC. In particular, these lawsuits allege that our donations to CVC violated RICO and various state laws. We filed motions to dismiss both of these lawsuits in March 2023. Our motions are fully briefed and are pending with the court.
We intend to vigorously defend ourselves against the claims made in these lawsuits.
340B Program Litigation
We participate in the Public Health Service’s 340B drug pricing program (the 340B program), through which we have agreed to sell our products to covered entities at no more than a statutory ceiling price, including through pharmacies that have contracts with such covered entities (340B contract pharmacies). Increasing use of 340B contract pharmacies, coupled with a lack of oversight and transparency, has resulted in increased risks of 340B statutory violations related to the diversion of 340B-purchased drugs to individuals who are not patients of the 340B covered entity, and to prohibited “duplicate discounts” when a Medicaid rebate is triggered on 340B-purchased drugs. In November 2020, we notified the U.S. Health Resources and Services Administration (HRSA) that we would begin implementing narrowly-tailored 340B contract pharmacy policies with the goal of stemming abuses of the 340B program without upsetting the status quo or creating hardship for covered entities or their patients. At around the same time, a number of other manufacturers also announced their own contract pharmacy policies.
In December 2020, the U.S. Department of Health and Human Services (HHS) General Counsel issued a non-binding Advisory Opinion (the Advisory Opinion) concluding that, among other things, pharmaceutical manufacturers are obligated to sell their drugs at the 340B discounted price to an unlimited number of 340B contract pharmacies. In May 2021, HRSA sent a letter to us stating that our 340B contract pharmacy policies violated the 340B statute. HRSA also sent materially similar letters to other pharmaceutical manufacturers. We responded to that letter by clarifying our policies and requesting additional information from HRSA. To date, HRSA has not responded.
The federal government’s pronouncements regarding the use of 340B contract pharmacies have triggered a variety of litigation. In one of those cases, the court concluded that the Advisory Opinion was “legally flawed,” and in response HHS withdrew the Advisory Opinion. Notwithstanding the withdrawal of the Advisory Opinion, HRSA has made clear that it is not withdrawing its May 2021 letter to us and the threat of enforcement action.
In June 2021, we commenced litigation against HRSA and HHS in the U.S. District Court for the District of Columbia seeking to vindicate the lawfulness of our 340B program contract pharmacy policies. Despite the litigation, in September 2021, HRSA sent to us, along with the other manufacturers challenging HRSA’s 340B interpretation, letters stating that HRSA is referring “this issue to the HHS Office of the Inspector General (OIG)” for potential enforcement action. We have not received any communication from the OIG regarding our 340B contract pharmacy policy. Meanwhile, the parties submitted and fully
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F-36 | United Therapeutics, a public benefit corporation |
15.
million. In January 2021, we closed the transaction and expensed the $ million within research and development in our consolidated statements of operations for the year ended December 31, 2021. We redeemed the voucher in connection with our submission of the NDA for Tyvaso DPI in April 2021.16.
million. In addition to the upfront payment, the transaction consideration includes potential earnout consideration, payable in cash, structured as a percent royalty on net sales of IVIVA’s kidney products, subject to certain reductions. The transaction was accounted for as an asset acquisition as substantially all of the fair value was concentrated in a single IPR&D asset we acquired. We allocated $ million of the purchase price to the IPR&D and recorded the expense within research and development in our consolidated statements of operations for the year ended December 31, 2023. For tax purposes, the purchase price allocated to the IPR&D is not deductible and was capitalized into the tax basis of the equity acquired. We also recorded an intangible asset of $ million related to the asset acquisition and recorded the amount within goodwill and other intangible assets, net in our consolidated balance sheet as of December 31, 2023.Business Combination
On October 29, 2023, we entered into an Agreement and Plan of Merger (the Merger Agreement) with Miromatrix Medical Inc. (Miromatrix), a publicly traded company developing bioengineered kidney and liver products. On December 13, 2023, we completed the transactions contemplated by the Merger Agreement and Miromatrix became a wholly-owned subsidiary of United Therapeutics. Pursuant to the terms of the Merger Agreement, we paid former Miromatrix shareholders $ per share in cash at closing, representing cash consideration paid to former Miromatrix shareholders of $ million. Former Miromatrix shareholders also received one contractual contingent value right per share, representing the right to receive a contingent payment of $ per share in cash (an aggregate of approximately $ million) upon the first implantation of Miromatrix’s development-stage, fully-implantable kidney product known as mirokidney into a living human patient by the end of 2025 in a clinical trial meeting requirements set forth in the form of the Contingent Value Rights Agreement attached to the Merger Agreement (the Milestone). In addition to the cash consideration above, the aggregate purchase price included $ million that we ascribed to the contingent value rights as of the closing date.
Purchase Price Allocation
The merger met the definition of a business combination in accordance with ASC 805, Business Combinations, and as such we applied the acquisition method to account for the transaction, which requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the closing date. The aggregate purchase price was allocated to the major categories of assets acquired and liabilities assumed based upon their estimated fair values at the closing date using primarily Level 2 and Level 3 inputs. These Level 2 and Level 3 valuation inputs included an estimate of future cash flows and discount rates. Additionally, estimated fair values were based, in part, upon third-party valuations of certain assets, which included specifically-identified intangible assets.
| Other current assets | | |
Intangible assets: | |
IPR&D | | |
Goodwill(1) | | |
Deferred tax assets, net | | |
Property, plant, and equipment, net | | |
Other non-current assets | | |
Total fair value of assets acquired | $ | | |
Accounts payable and accrued expenses | | |
Other current liabilities | | |
Other non-current liabilities | | |
Total fair value of liabilities assumed | $ | | |
Total purchase price | $ | | |
(1)The goodwill is not deductible for income tax purposes.
We determined the fair value of the IPR&D using the multi-period earnings method under the income approach. This method reflects the present value of the projected cash flows that are expected to be generated by the IPR&D, less charges representing the required return on other assets to sustain those cash flows. The multi-period earnings method is a Level 3 fair value measurement. Significant assumptions inherent in determining fair value of the IPR&D included annual net cash flows over a period of time and a discount rate applied to those cash flows to reflect the overall risk of the asset.
We ascribed $ million to the contingent value rights as of the closing date based on a probability weighted discounted cash flow model, utilizing probability adjusted expectations for achieving the Milestone. In making this determination, we considered expectations regarding the timing and probability of achieving the Milestone by the end of 2025.
Following the acquisition, the operating results of Miromatrix have been included in our consolidated financial statements. The acquisition did not have a material impact on our consolidated financial statements, and therefore, historical and pro forma disclosures have not been presented.
Costs incurred to complete the acquisition and integrate Miromatrix into our business were expensed as incurred and included within selling, general and administrative in our consolidated statements of operations. During the year ended December 31, 2023, we recognized $ million of acquisition-related costs. These costs represented transaction costs, legal fees, and professional third-party service fees.
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F-38 | United Therapeutics, a public benefit corporation |
| | $ | | | | $ | | | | $ | () | | | $ | | | | Year Ended December 31, 2022 | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | |
Year Ended December 31, 2021(2) | | $ | | | | $ | | | | $ | | | | $ | () | | | $ | | |
(1)Other additions relate to valuation allowances on certain tax attributes obtained through acquisitions. Deductions relate to state net operating losses.
(2)Deductions relate primarily to changes in capital investments.
| | | | | | | | | | | | | | | | | | | | | | | |
| | Inventory Reserves |
| | Balance at Beginning of Year | | Additions Charged to Expense | | Deductions | | Balance at End of Year |
| Year Ended December 31, 2023 | $ | | | | $ | | | | $ | () | | | $ | | |
| Year Ended December 31, 2022 | $ | | | | $ | | | | $ | () | | | $ | | |
| Year Ended December 31, 2021 | $ | | | | $ | | | | $ | () | | | $ | | |
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with participation of our Chairperson and Chief Executive Officer and Chief Financial Officer and Treasurer, has evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as of December 31, 2023. Based on that evaluation, our Chairperson and Chief Executive Officer and Chief Financial Officer and Treasurer concluded that our disclosure controls and procedures were effective as of December 31, 2023.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended). Our internal control over financial reporting was designed to provide reasonable assurance to our management and Board of Directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. All internal controls over financial reporting, no matter how well designed, have inherent limitations. As a result of these inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those internal controls determined to be effective can provide only reasonable assurance with respect to the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013). Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of our internal control over financial reporting. Based on this assessment, our management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
Ernst & Young LLP, an independent registered public accounting firm, has issued an attestation report on our internal control over financial reporting. The report of Ernst & Young LLP is contained in Item 8 of this Report.
Attestation of Independent Registered Public Accounting Firm
The attestation report of our independent registered public accounting firm regarding internal control over financial reporting is set forth in Item 8 of this Report under the caption “Report of Independent Registered Public Accounting Firm” and incorporated herein by reference.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Item 9B. Other Information
(c)
, , a of the company, a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to STAP awards between April 8, 2024 and April 26, 2024, subject to certain conditions. These STAP awards are scheduled to expire on June 26, 2024. | | | | | |
65 | United Therapeutics, a public benefit corporation |
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers, and Corporate Governance
Information as to the individuals serving on our board of directors is set forth below under the heading Board of Directors. Additional information required by Item 10 regarding nominees and directors appearing under Proposal No. 1: Election of Directors in our definitive proxy statement for our 2024 annual meeting of shareholders currently scheduled for June 26, 2024 (the 2024 Proxy Statement) is hereby incorporated herein by reference. Information regarding our executive officers appears in Item 1 of this Report under the heading Information about our Executive Officers. Information regarding our Audit Committee and our Audit Committee’s financial expert appearing under the heading Committees of our Board of Directors—Audit Committee in our 2024 Proxy Statement is hereby incorporated herein by reference.
Information appearing under the heading Delinquent Section 16(a) Reports in our 2024 Proxy Statement is hereby incorporated herein by reference.
We have a written Code of Conduct and Business Ethics that applies to our principal executive officer, principal financial officer and our principal accounting officer and every other director, officer and employee of United Therapeutics. The Code of Conduct and Business Ethics is available on our Internet website at http://ir.unither.com/corporate-governance. A copy of the Code of Conduct and Business Ethics will be provided free of charge by making a written request and mailing it to our corporate headquarters offices to the attention of the Investor Relations Department. If any amendment to, or a waiver from, a provision of the Code of Conduct and Business Ethics that applies to the principal executive officer, principal financial officer and principal accounting officer is made, we intend to post such information on our Internet website within four business days at www.unither.com.
Board of Directors
Christopher Causey, M.B.A.
Former Consultant and Healthcare Executive
Raymond Dwek, C.B.E., F.R.S.
Emeritus Director, Oxford Glycobiology Institute, Oxford University
Richard Giltner
Former Portfolio Manager at Lyxor Asset Management, an asset management group at Société Générale, S.A.
Katherine Klein, Ph.D.
Professor of Management, The Wharton School of the University of Pennsylvania
Ray Kurzweil
Principal Researcher and AI Visionary, Google Inc.
Linda Maxwell, M.D., M.B.A.
Surgeon; Operating Partner, DCVC
Nilda Mesa, J.D.
Adjunct Professor, Columbia University; Former Director, NYC Mayor’s Office of Sustainability
Judy D. Olian, Ph.D.
President, Quinnipiac University
Christopher Patusky, J.D., M.G.A.
Founding Principal, Patusky Associates, LLC
Martine Rothblatt, Ph.D., J.D., M.B.A.
Chairperson and Chief Executive Officer of United Therapeutics
Louis Sullivan, M.D.
President Emeritus, Morehouse School of Medicine; Former Secretary, U.S. Department of Health and Human Services
Tommy Thompson, J.D.
Former Governor of Wisconsin; Former Secretary, U.S. Department of Health and Human Services
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67 | United Therapeutics, a public benefit corporation |
Item 11. Executive Compensation
Information concerning executive compensation required by Item 11 will appear under the headings Director Compensation, Compensation Discussion and Analysis, and Executive Compensation Data in our 2024 Proxy Statement and is incorporated herein by reference.
Information concerning the Compensation Committee required by Item 11 will appear under the heading Compensation Committee Report in our 2024 Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information regarding beneficial ownership of our common stock required by Item 12 will appear under Beneficial Ownership of Common Stock in our 2024 Proxy Statement and is incorporated herein by reference.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table presents information as of December 31, 2023, regarding our securities authorized for issuance under equity compensation plans:
| | | | | | | | | | | | | | | | | | | | |
| Plan category | | Number of securities to be issued upon exercise of outstanding options and RSUs (a)(3) | | Weighted average exercise price of outstanding options (b)(4) | | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)(5) |
Equity compensation plan approved by security holders(1) | | 7,153,777 | | | $ | 136.60 | | | 5,273,018 | |
Equity compensation plan not approved by security holders(2) | | 24,835 | | | — | | | 24,586 | |
| Total | | 7,178,612 | | | $ | 136.60 | | | 5,297,604 | |
(1)All outstanding stock options were issued under our two equity incentive plans approved by security holders in 1999 and 2015. The majority of outstanding RSUs were issued under the 2015 Plan. In addition, our employees have outstanding rights to purchase our common stock at a discount as part of our ESPP, which was approved by security holders in 2011. No further awards will be issued under the 1999 Plan. Information regarding these plans is contained in Note 8—Share-Based Compensation to our consolidated financial statements.
(2)We have one equity incentive plan, the 2019 Inducement Plan, that has not been approved by our shareholders, as permitted by the Nasdaq Stock Market rules. The 2019 Inducement Plan was approved by our Board of Directors in February 2019 and provides for the issuance of up to 99,000 shares of our common stock in the aggregate under awards granted to newly-hired employees. Information regarding this plan is contained in Note 8—Share-Based Compensation to our consolidated financial statements.
(3)Column (a) includes 6,213,853 shares of our common stock issuable upon the exercise of outstanding stock options issued under the 1999 Plan and 2015 Plan; 939,924 shares issuable upon the vesting of outstanding RSUs issued under the 2015 Plan; and 24,835 shares issuable upon the vesting of outstanding RSUs issued under the 2019 Inducement Plan. The number under column (a) represents the actual number of shares issuable under our outstanding awards without giving effect to the share counting formula described below in footnote 5.
(4)Column (b) represents the weighted average exercise price of the outstanding stock options only. The outstanding RSUs are not included in this calculation because they do not have an exercise price.
(5)Column (c) includes 2,506,133, 2,766,885, and 24,586 of shares available for future issuance under the ESPP, the 2015 Plan, and the 2019 Inducement Plan, respectively. Under the ESPP, employees may purchase shares based upon a six-month offering period at an amount equal to the lesser of (1) 85 percent of the closing market price of the Common Stock on the first day of the offering period, or (2) 85 percent of the closing market price of the Common Stock on the last day of the offering period. See Note 8—Share-Based Compensation—ESPP for more information. The 2015 Plan and 2019 Inducement Plan use a share counting formula for determining the number of shares available for issuance under the plans. In accordance with this formula, each RSU granted prior to March 17, 2020 under the 2015 Plan and each RSU granted under the 2019 Inducement Plan depletes the number of shares available for future issuance by 2.14 shares, while each RSU granted on or after March 17, 2020 under the 2015 Plan depletes the number of shares available for future issuance by 1.35 shares. Therefore, if any RSU does not vest, the number of shares available for future issuance will increase by 1.35 and 2.14 under the 2015 Plan and 2019 Plan, respectively, because of the share counting formula described above. Each stock option granted under the 2015 Plan depletes the number of shares available for future issuance by one share and does not use the share counting formula described above.
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69 | United Therapeutics, a public benefit corporation |
Item 13. Certain Relationships and Related Transactions, and Director Independence
Information concerning related party transactions and director independence required by Item 13 will appear under the headings Other Matters—Certain Relationships and Related Party Transactions, Our Corporate Governance—Board of Directors and Nominees—Director Independence, and Our Corporate Governance—Board Structure—Committees of Our Board of Directors in our 2024 Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services
Information required by Item 14 concerning the principal accounting fees paid by the Registrant and the Audit Committee’s pre-approval policies and procedures, will appear under the heading Audit Matters in our 2024 Proxy Statement and is incorporated herein by reference.
PART IV
Item 15. Exhibits and Financial Statement Schedules
In reviewing the agreements included or incorporated by reference as exhibits to this Report, it is important to note that they are included to provide investors with information regarding their terms, and are not intended to provide any other facts or disclose any other information about United Therapeutics or the other parties to the agreements. The agreements contain representations and warranties made by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the other parties to the applicable agreement, and: (1) should not be treated as categorical statements of fact, but rather as a way of allocating risk between the parties; (2) have in some cases been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the agreement; (3) may apply standards of materiality in a way that is different from what may be material to investors; and (4) were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments.
Accordingly, these representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about United Therapeutics may be found elsewhere in this Report and our other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.
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| (a)(1) | Our financial statements filed as part of this report on Form 10-K are set forth in the Index to Consolidated Financial Statements under Part II, Item 8 of this Form 10-K. |
| (a)(2) | The Schedule II—Valuation and Qualifying Accounts is filed as part of this Form 10-K. All other schedules are omitted because they are not applicable or not required, or because the required information is included in our consolidated statements or notes thereto. |
| (a)(3) | Exhibits filed as a part of this Form 10-K are listed on the Exhibit Index, which is incorporated by reference herein. |
Certain exhibits to this report have been included only with the copies of this report filed with the Securities and Exchange Commission. Copies of individual exhibits will be furnished to shareholders upon written request to United Therapeutics and payment of a reasonable fee (covering the expense of furnishing copies). Shareholders may request exhibit copies by contacting: United Therapeutics Corporation, Attn: Investor Relations, 1000 Spring Street, Silver Spring, Maryland 20910.
Exhibit Index
| | | | | |
Exhibit No. | Description |
| 2.1* | |
| 3.1 | |
| 3.2 | |
| | | | | |
| 4.1 | Reference is made to Exhibits 3.1 and 3.2. |
4.2† | |
| 10.1 | |
| 10.2** | |
| 10.3** | |
| 10.4** | |
| 10.5** | |
| 10.6** | |
| 10.7** | |
| 10.8** | |
| 10.9** | |
| 10.10** | |
| 10.11** | |
| 10.12** | |
| 10.13** | |
| 10.14** | |
| 10.15** | |
| 10.16** | |
| 10.17** | |
| 10.18** | |
| 10.19 | |
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71 | United Therapeutics, a public benefit corporation |
| | | | | |
Exhibit No. | Description |
| 10.20** | |
| 10.21 | |
| 10.22** | |
| 10.23** | |
| 10.24** | |
| 10.25** | |
| 10.26** | |
| 10.27** | |
| 10.28** | |
| 10.29** | |
| 10.30** | |
| 10.31** | |
| 10.32** | |
| 10.33** | |
| 10.34** | |
| 10.35** | |
| 10.36** | |
10.37** | |
10.38** | |
| | | | | |
Exhibit No. | Description |
| 10.39** | |
| 10.40** | |
| 10.41* | |
| 10.42 | |
| 10.43 | |
| 10.44* | |
| 10.45+ | |
| 10.46+ | |
| 10.47+ | |
| 10.48+ | |
| 10.49 | |
10.50 | |
10.51 | |
10.52+† | |
10.53 | |
| 10.54 | |
| | | | | |
73 | United Therapeutics, a public benefit corporation |
| | | | | |
Exhibit No. | Description |
| 10.55 | |
| 10.56 | |
| 10.57 | |
| 10.58 | |
10.59† | |
| 10.60 | Credit Agreement, dated as of March 31, 2022, among the Registrant, certain of its subsidiaries party thereto, as guarantors, the lenders referred to therein, and Wells Fargo Bank, National Association, as administrative agent and as a swingline lender, incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed on April 1, 2022. |
10.61+ | |
21† | |
23.1† | |
31.1† | |
31.2† | |
32.1† | |
32.2† | |
97† | |
101† | The following financial information from our Annual Report on Form 10‑K for the year ended December 31, 2023, filed with the SEC on February 21, 2024, formatted in Inline Extensible Business Reporting Language (iXBRL): (1) our Consolidated Balance Sheets as of December 31, 2023 and 2022, (2) our Consolidated Statements of Operations for each of three years in the period ended December 31, 2023, (3) our Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, 2023, (4) our Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, 2023, (5) our Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2023, and (6) the Notes to our Consolidated Financial Statements. |
104† | Cover Page Interactive Data File (embedded within the iXBRL document) |
+ Certain identified information has been omitted from this exhibit because it is both (1) not material and (2) would be competitively harmful if publicly disclosed.
* Confidential treatment has been requested with respect to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended or Rule 24b‑2 of the Securities Act of 1934, as amended. The omitted portions of this document have been filed with the Securities and Exchange Commission.
** Designates management contracts and compensation plans.
† Filed herewith.
Note: Except as otherwise noted above, all exhibits incorporated by reference to the Registrant’s previously filed reports with the Securities and Exchange Commission are filed under File No. 000‑26301.
Item 16. Form 10-K Summary
None.
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
| | | | | | | | |
| | UNITED THERAPEUTICS CORPORATION |
| | | |
| By: | /s/ MARTINE ROTHBLATT |
| February 21, 2024 | | Martine Rothblatt, Ph.D. Chairperson and Chief Executive Officer |
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75 | United Therapeutics, a public benefit corporation |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| | | | | | | | | | | | | | | | | | | | |
| Signatures | | Title | | Date | |
| | | | | | |
| /s/ MARTINE ROTHBLATT | | Chairperson, Chief Executive Officer, and Director (Principal Executive Officer) | | February 21, 2024 | |
| Martine Rothblatt | | | |
| | | | | | |
| /s/ JAMES C. EDGEMOND | | Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer) | | February 21, 2024 | |
| James C. Edgemond | | | |
| | | | | | |
| /s/ CHRISTOPHER CAUSEY | | Director | | February 21, 2024 | |
| Christopher Causey | | | |
| | | | | | |
| /s/ RAYMOND DWEK | | Director | | February 21, 2024 | |
| Raymond Dwek | | | |
| | | | | | |
| /s/ RICHARD GILTNER | | Director | | February 21, 2024 | |
| Richard Giltner | | | |
| | | | | | |
| /s/ KATHERINE KLEIN | | Director | | February 21, 2024 | |
| Katherine Klein | | | |
| | | | | | |
| /s/ RAYMOND KURZWEIL | | Director | | February 21, 2024 | |
| Raymond Kurzweil | | | |
| | | | | | |
| /s/ LINDA MAXWELL | | Director | | February 21, 2024 | |
| Linda Maxwell | | | |
| | | | | | |
| /s/ NILDA MESA | | Director | | February 21, 2024 | |
| Nilda Mesa | | | |
| | | | | | |
| /s/ JUDY D. OLIAN | | Director | | February 21, 2024 | |
| Judy D. Olian | | | |
| | | | | | |
| /s/ CHRISTOPHER PATUSKY | | Director | | February 21, 2024 | |
| Christopher Patusky | | | |
| | | | | | |
| /s/ LOUIS W. SULLIVAN | | Director | | February 21, 2024 | |
| Louis W. Sullivan | | | |
| | | | | | |
| /s/ TOMMY G. THOMPSON | | Director | | February 21, 2024 | |
| Tommy Thompson | | | |
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