UNITED THERAPEUTICS CORP – 10-K – Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our consolidated financial statements and related notes to our consolidated financial statements. All statements in this filing are made as of the date this Report is filed with theU.S. Securities and Exchange Commission (SEC). We undertake no obligation to publicly update or revise these statements, whether as a result of new information, future events or otherwise. The following Management's Discussion and Analysis of Financial Condition and Results of Operations and other sections of this Report contain forward-looking statements made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report on Form 10-K is filed with theSEC , include, among others, statements related to the following: •Expectations of revenues, expenses, profitability, cash flows, and growth in the number of patients being treated with our products, including anticipated growth in the number of Tyvaso patients as a result of the expansion of its label to include pulmonary hypertension associated with interstitial lung disease (PH-ILD) and anticipated growth in revenues following the recent commercial launch of Tyvaso DPI;
•The sufficiency of our cash on hand to support operations;
•Our ability to obtain financing on terms favorable to us or at all;
•Our ability to obtain and maintain domestic and international regulatory
approvals;
•Our ability to maintain attractive pricing and reimbursement levels for our products, in light of increasing competition, including from generic products, pressure from government and other payers to decrease the costs associated with healthcare, including the potential impact of the Inflation Reduction Act of 2022 (IRA) on our business;
•The expected volume and timing of sales of our commercial products, as well as
potential future commercial products, including the anticipated effect of
various research and development efforts on sales of these products;
•The timing and outcome of clinical studies, other research and development
efforts, and related regulatory filings and approvals;
•The outcome of pending and potential future legal and regulatory actions by theU.S. Food and Drug Administration (FDA) and other regulatory and government enforcement agencies, and the anticipated duration of regulatory exclusivity for our products; •The timing and outcome of ongoing litigation, including the lawsuit filed against us bySandoz, Inc. andLiquidia PAH, LLC (formerly known asRareGen, LLC ); our patent and trade secret litigation with Liquidia Technologies, Inc. (Liquidia) related to its new drug application (NDA) for Yutrepia; our litigation with Humana Inc.,United Healthcare Services, Inc. , MSP Recovery Claims,Series LLC , and related entities; and our litigation with theU.S. Department of Health and Human Services and theU.S. Health Resource Services Administration related to thePublic Health Service's 340B drug pricing program;
•The impact of competing therapies on sales of our commercial products,
including the impact of generic versions of Adcirca and Remodulin; established
therapies such as Uptravi; and newly-developed therapies such as Merck's
sotatercept and Liquidia's Yutrepia;
•The expectation that we will be able to manufacture sufficient quantities and maintain adequate inventories of our commercial products, through both our in-house manufacturing capabilities and third-party manufacturing sites, and our ability to obtain and maintain related approvals by the FDA and other regulatory agencies; •The adequacy of our intellectual property protection and the validity and expiration dates of the patents we own or license, as well as the regulatory exclusivity periods for our products;
•The effect of our recent conversion to a
•Any statements that include the words "believe," "seek," "expect,"
"anticipate," "forecast," "project," "intend," "estimate," "should," "could,"
"may," "will," "plan," or similar expressions; and
•Other statements contained or incorporated by reference in this Report that are
not historical facts.
We caution you that these statements are not guarantees of future performance and are subject to numerous evolving risks and uncertainties that we may not be able to accurately predict or assess, and that may cause our actual results to differ materially from anticipated results, including the risks and uncertainties we describe in Part I, Item 1A-Risk Factors of this Report and factors described in other cautionary statements, cautionary language, and risk factors set forth in our other filings with theSEC .
46
--------------------------------------------------------------------------------
Overview of Marketed Products
We market and sell the following commercial products:
•Tyvaso and Tyvaso DPI. Tyvaso is an inhaled formulation of the prostacyclin analogue treprostinil, approved by the FDA and regulatory authorities inArgentina ,Israel , andJapan to improve exercise ability in patients with pulmonary arterial hypertension (PAH). Tyvaso was also approved by the FDA inMarch 2021 and by regulators inIsrael inDecember 2022 to improve exercise ability in patients with PH-ILD. InMay 2022 , we also obtained FDA approval of Tyvaso DPI to treat PAH and PH-ILD, and we initiated commercial shipments of Tyvaso DPI to our distributors inJune 2022 . •Remodulin, a continuously-infused formulation of treprostinil, approved by the FDA for subcutaneous and intravenous administration to diminish symptoms associated with exercise in patients with PAH. Remodulin has also been approved in various countries outside ofthe United States . InFebruary 2021 , we launchedU.S. sales of the Remunity Pump, a new subcutaneous delivery system for Remodulin.
•Orenitram, a tablet dosage form of treprostinil, approved by the FDA to delay
disease progression and improve exercise capacity in PAH patients.
•Unituxin, a monoclonal antibody approved in
•Adcirca, an oral PDE-5 inhibitor approved by the FDA to improve exercise
ability in PAH patients.
For additional detail regarding our commercial products, see Part I,
Item 1-Business-Our Commercial Products.
Research and Development
We are engaged in research and development of new indications and delivery devices for our existing products. We recently developed a new pump for Remodulin, called the Remunity Pump, and are currently developing a new version of the Remunity Pump. We are also working with a medical device manufacturer to develop new delivery systems for Remodulin. We are studying Tyvaso in patients with idiopathic pulmonary fibrosis (the TETON studies). In addition, we are developing new products to treat PAH (RemoPro and ralinepag). We are also heavily engaged in early-stage research and development of a number of organ transplantation-related technologies including regenerative medicine, 3-D organ bioprinting, xenotransplantation, and ex vivo lung perfusion. For additional detail regarding our research and development programs, see Part I, Item 1-Business-Research and Development.
Revenues
Our total revenues consist primarily of sales of the commercial products noted above, together with associated sales of delivery devices (in the case of Remodulin, Tyvaso, and Tyvaso DPI). We have entered into separate, non-exclusive distribution agreements withAccredo Health Group, Inc. and its affiliates andCaremark, L.L.C. to distribute Tyvaso, Tyvaso DPI, Remodulin, the Remunity Pump, and Orenitram inthe United States , and we have entered into an exclusive distribution agreement withASD Specialty Healthcare, Inc. , an affiliate of AmerisourceBergen Corporation, to distribute Unituxin inthe United States . We also sell Tyvaso, Remodulin, and Unituxin to distributors internationally. We sell Adcirca through the pharmaceutical wholesale network of Eli Lilly and Company (Lilly). To the extent we have increased the price of any of these products, increases have typically been in the single-digit percentages per year, except for Adcirca, the price of which is set solely by Lilly. We require our specialty pharmaceutical distributors to maintain reasonable levels of inventory reserves for our treprostinil-based therapies because the interruption of these therapies can be life threatening. Our specialty pharmaceutical distributors typically place monthly or semi-monthly orders based on current utilization trends and contractual minimum and maximum inventory requirements. As a result, sales of our treprostinil-based therapies can vary depending on the timing and magnitude of these orders and do not precisely reflect changes in patient demand.
Operating Expenses
We devote substantial resources to our various clinical trials and other research and development efforts, which are conducted both internally and through third parties. From time to time, we also license or acquire additional technologies and compounds to be incorporated into our development pipeline. Our operating expenses include the costs described below.
Cost of Sales
Our cost of sales primarily includes costs to manufacture our products, royalty and sales-based milestone payments under license agreements granting us rights to sell related products, direct and indirect distribution costs incurred in the sale of our products, and the costs of inventory reserves for current and projected obsolescence. These costs also include share-based
2022 Annual Report 47
--------------------------------------------------------------------------------
compensation and salary-related expenses for direct manufacturing and indirect support personnel, quality review and release for commercial distribution, direct materials and supplies, depreciation, facilities-related expenses, and other overhead costs. Research and Development Our research and development expenses primarily include costs associated with the research and development of products and post-marketing research commitments. These costs also include share-based compensation and salary-related expenses for research and development functions, professional fees for preclinical and clinical studies, costs associated with clinical manufacturing, facilities-related expenses, regulatory costs, and costs associated with payments to third-party contract manufacturers before FDA approval of the relevant product. Expenses also include costs for third-party arrangements, including upfront fees and milestone payments required under license arrangements for therapies under development. We do not track fully-burdened research and development expenses by individual product candidate.
Selling, General, and Administrative
Our selling, general, and administrative expenses primarily include costs associated with the commercialization of approved products and general and administrative costs to support our operations. Selling expenses also include share-based compensation, salary-related expenses, product marketing and sales operations costs, and other costs incurred to support our sales efforts. General and administrative expenses also include our core corporate support functions such as human resources, finance and legal, and external costs to support our core business such as insurance premiums, legal fees, and other professional service fees. Share-Based Compensation Historically, we granted stock options under our Amended and Restated Equity Incentive Plan and awards under our Share Tracking Awards Plan (the STAP). Issuance of awards under both of these plans was discontinued in 2015. Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (as amended to date, the 2015 Plan), which provides for the issuance of up to 11,500,000 shares of our common stock, including the 500,000 shares added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders inJune 2022 . InFebruary 2019 , our Board of Directors approved the 2019 Inducement Stock Incentive Plan (the 2019 Inducement Plan), which provides for the issuance of up to 99,000 shares of our common stock pursuant to awards granted to newly-hired Unitherians. Currently, we grant equity-based awards to Unitherians and members of our Board of Directors in the form of stock options and restricted stock units under the 2015 Plan, and we may grant restricted stock units to newly-hired Unitherians under the 2019 Inducement Plan. The grant date fair values of stock options and restricted stock units are recognized as share-based compensation expense ratably over their vesting periods. The fair value of STAP awards and stock options is measured using inputs and assumptions under the Black-Scholes-Merton model. The fair value of restricted stock units is measured using our stock price on the date of grant. Although we no longer grant STAP awards, we had approximately 0.6 million STAP awards outstanding as ofDecember 31, 2022 . We account for STAP awards as liabilities because they are settled in cash. As such, we must re-measure the fair value of STAP awards at the end of each financial reporting period until the awards are no longer outstanding. Changes in our liability associated with outstanding STAP awards as a result of such re-measurements are recorded as adjustments to share-based compensation expense (benefit) and can create substantial volatility within our operating expenses from period to period. The following factors, among others, have a significant impact on the amount of share-based compensation expense (benefit) recognized in connection with STAP awards from period to period: (1) volatility in the price of our common stock (specifically, increases in the price of our common stock will generally result in an increase in our liability and related compensation expense, while decreases in our stock price will generally result in a reduction in our liability and related compensation expense); and (2) decreases in the number of outstanding awards.
Future Prospects
We anticipate that overall revenue growth over the near-term will be driven primarily by: (1) growth in sales of Tyvaso as a result of the expansion of its label to include PH-ILD; (2) growth in sales of the newly-launched Tyvaso DPI; (3) continued growth in the number of patients prescribed Orenitram following our expansion of the Orenitram label to reflect the results of the FREEDOM-EV study; and (4) modest price increases for some of our products; partially offset by further generic erosion of Adcirca sales. We believe that additional revenue growth in the medium- and longer-term will be driven by new products and new indications for existing products being developed in our pipeline, as described above under Part I, Item 1-Business-Research and Development. Our ability to achieve our objectives, grow our business, and maintain profitability will depend on many factors, including among others: (1) the timing and outcome of preclinical research, clinical trials, and regulatory approval applications for products we develop; (2) the timing and degree of our success in commercially launching new products; (3) the demand for our products; (4) the price of our products and the reimbursement of our products by public and private health insurance organizations, including the impact on such prices and reimbursement amounts as a result of the IRA; (5) the competition we face within our industry,
48
--------------------------------------------------------------------------------
including competition from generic companies and new PAH therapies; (6) our ability to effectively manage our business in an increasingly complex legal and regulatory environment; (7) our ability to defend against challenges to our patents; and (8) the risks identified in Part I, Item 1A-Risk Factors, included in this Report. We operate in a highly competitive market in which a small number of large pharmaceutical companies control a majority of available PAH therapies. These pharmaceutical companies are well established in the market and possess greater financial, technical, and marketing resources than we do. In addition, there are a number of investigational products in late-stage development that, if approved, may erode the market share of our existing commercial therapies and make market acceptance more difficult to achieve for any therapies we attempt to market in the future. Results of Operations This section of this Report generally discusses 2022, 2021, and 2020 items and year-to-year comparisons between 2022 and 2021. Discussions of year-to-year comparisons between 2021 and 2020 that are not included in this Report can be found in Part II, Item 7-Management's Discussion and Analysis of Financial Condition and Results of Operations-Results of Operations of our Form 10-K filed onFebruary 24, 2022 (our 2021 Annual Report).
Revenues
The table below presents the components of total revenues (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Net product sales: Tyvaso(1)$ 873.0 $ 607.5 $ 483.3 $ 265.5 $ 124.2 44 % 26 % Remodulin(2) 500.2 513.7 516.7 (13.5) (3.0) (3) % (1) % Orenitram 325.1 306.1 293.1 19.0 13.0 6 % 4 % Unituxin 182.9 202.3 122.9 (19.4) 79.4 (10) % 65 % Adcirca 41.3 55.9 67.3 (14.6) (11.4) (26) % (17) % Other 13.8 - - 13.8 - NM(3) NM(3)
Total revenues$ 1,936.3 $ 1,685.5 $ 1,483.3 $ 250.8 $ 202.2 15 % 14 %
(1) Net product sales include both the drug product and the respective
inhalation devices for both Tyvaso and Tyvaso DPI.
(2) Net product sales include sales of infusion devices, such as the Remunity
Pump.
(3) Calculation is not meaningful.
Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and
Orenitram) grew by
Tyvaso net product sales increased in 2022, as compared to 2021, primarily due to an increase in quantities sold and, to a lesser extent, the impact of a price increase and lower gross-to-net deductions. The increase in quantities sold was driven by the commercial launch of Tyvaso DPI inJune 2022 and continued growth in the number of patients following the PH-ILD label expansion inMarch 2021 . Remodulin net product sales decreased in 2022, as compared to 2021, due to a$15.9 million decrease inU.S. Remodulin net product sales, partially offset by a$2.4 million increase in international Remodulin net product sales. The decrease inU.S. Remodulin net product sales was driven by a decrease in quantities sold, partially offset by lower gross-to-net deductions.
Orenitram net product sales increased in 2022, as compared to 2021, primarily
due to a price increase and lower gross-to-net deductions.
Unituxin net product sales decreased in 2022, as compared to 2021, primarily due
to a decrease in quantities sold, partially offset by a price increase.
Adcirca net product sales decreased in 2022, as compared to 2021, due to a
decline in quantities sold as a result of generic competition for Adcirca and
higher gross-to-net deductions.
2022 Annual Report 49
--------------------------------------------------------------------------------
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 and available industry data, including our estimate of inventory remaining in the distribution channel. The tables below include a reconciliation of the liability accounts associated with these deductions (in millions):
Year Ended
Rebates & Prompt Pay Allowance for Chargebacks Discounts 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 & Prompt Pay Allowance for Chargebacks Discounts 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 Year Ended December 31, 2020 Rebates & Prompt Pay Allowance for Chargebacks Discounts Sales Returns Distributor Fees Total Balance, January 1, 2020 $ 51.7$ 2.6 $ 14.2 $ 4.1$ 72.6 Provisions attributed to sales in: Current period 196.1 32.5 - 20.6 249.2 Prior periods (0.2) - - (0.3) (0.5) Payments or credits attributed to sales in: Current period (139.7) (29.6) - (16.9) (186.2) Prior periods (42.6) (2.5) (1.7) (3.8) (50.6) Balance, December 31, 2020 $ 65.3$ 3.0 $ 12.5 $ 3.7$ 84.5 50 United Therapeutics, a public benefit corporation
--------------------------------------------------------------------------------
Cost of Sales
The table below summarizes cost of sales by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Category: Cost of sales$ 146.7 $ 116.7 $ 101.0 $ 30.0 $ 15.7 26 % 16 % Share-based compensation expense(1) 4.9 5.8 7.1 (0.9) (1.3) (16) % (18) % Total cost of sales$ 151.6 $ 122.5 $ 108.1 $ 29.1 $ 14.4 24 % 13 %
(1)Refer to Share-Based Compensation section below for discussion.
Cost of sales, excluding share-based compensation. The increase in cost of sales for the year endedDecember 31, 2022 , as compared to the same period in 2021, was primarily due to an increase in royalty expense and product costs for Tyvaso DPI following the commercial launch of the product inJune 2022 .
Research and Development
The table below summarizes the nature of research and development expense by
major expense category (dollars in millions):
Year Ended December 31, Dollar Change Percentage Change 2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Category: External research and development(1)$ 168.8 $ 156.7 $ 177.4 $ 12.1 $ (20.7) 8 % (12) % Internal research and development(2) 131.4 117.2 111.3 14.2 5.9 12 % 5 % Share-based compensation expense(3) 23.8 24.4 29.5 (0.6) (5.1) (2) % (17) % Impairments(4) - 130.0 0.5 (130.0) 129.5 (100) % NM(6) Other(5) (1.1) 111.8 39.0 (112.9) 72.8 (101) % 187 % Total research and development expense$ 322.9 $ 540.1 $ 357.7 $ (217.2) $ 182.4 (40) % 51 %
(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)Refer to 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. (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, and a one-time expense associated with the redemption of a pediatric disease priority review voucher in 2021.
(6)Calculation is not meaningful.
Research and development, excluding share-based compensation. The decrease in research and development expense for the year endedDecember 31, 2022 , as compared to the same period in 2021, was due to: (1) a$107.3 million IPR&D impairment charge related to ourMarch 2021 decision to discontinue theU.S. development of Trevyent; (2) a$105.0 million purchase of a pediatric disease priority review voucher inJanuary 2021 , which we redeemed upon submission of our NDA for Tyvaso DPI; and (3) impairment charges related to property, plant, and equipment during 2021. 2022 Annual Report 51
--------------------------------------------------------------------------------
Selling, General, and Administrative
The table below summarizes selling, general, and administrative expense by major
category (dollars in millions):
Year EndedDecember 31 , Dollar Change
Percentage Change
2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Category: General and administrative$ 333.2 $ 294.3 $ 241.8 $ 38.9 $ 52.5 13 % 22 % Sales and marketing 70.8 64.4 54.9 6.4 9.5 10 % 17 % Share-based compensation expense(1) 78.1 108.3 127.2 (30.2) (18.9) (28) % (15) % Total selling, general, and administrative expense$ 482.1 $ 467.0 $ 423.9 $ 15.1 $ 43.1 3 % 10 %
(1)Refer to Share-Based Compensation section below for discussion.
General and administrative, excluding share-based compensation. The increase in general and administrative expense for the year endedDecember 31, 2022 , as compared to the same period in 2021, was primarily due to: (1) an increase in branded prescription drug fee expense associated with sales of Tyvaso; and (2) impairment charges related to property, plant, and equipment. The branded prescription drug fee is a required fee imposed under the Patient Protection and Affordable Care Act of 2010, which became applicable to Tyvaso in 2021, and is now applicable to Tyvaso DPI, as a result of their approval for treatment of PH-ILD, an indication that currently does not have orphan designation from the FDA. Share-Based Compensation The table below summarizes share-based compensation expense by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Category: Stock options$ 22.6 $ 25.4 $ 44.0 $ (2.8) $ (18.6) (11) % (42) % Restricted stock units 35.7 24.7 20.5 11.0 4.2 45 % 20 % STAP awards 46.7 86.6 97.8 (39.9) (11.2) (46) % (11) % Employee stock purchase plan 1.8 1.8 1.5 - 0.3 - % 20 % Total share-based compensation expense$ 106.8 $ 138.5 $ 163.8 $ (31.7) $ (25.3) (23) % (15) %
The table below summarizes share-based compensation expense by line item in our
consolidated statements of operations (dollars in millions):
Year Ended December 31, Dollar Change Percentage Change 2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Cost of sales$ 4.9 $ 5.8 $ 7.1 $ (0.9) $ (1.3) (16) % (18) % Research and development 23.8 24.4 29.5 (0.6) (5.1) (2) % (17) % Selling, general, and administrative 78.1 108.3 127.2 (30.2) (18.9) (28) % (15) %
Total share-based compensation expense
(23) % (15) % The decrease in share-based compensation expense for the year endedDecember 31, 2022 , as compared to the same period in 2021, was primarily due to: (1) a decrease in STAP expense driven by a 29 percent increase in our stock price during 2022, as compared to a 42 percent increase in our stock price during 2021; and (2) a decrease in stock option expense due to fewer awards granted and remaining outstanding in 2022, as compared to the same period in 2021, partially offset by an increase in restricted stock unit expense. Refer to Note 8-Share-Based Compensation, to our consolidated financial statements for more information.
52
--------------------------------------------------------------------------------
Other (Expense) Income, Net
The change in other (expense) income, net for the year endedDecember 31, 2022 , as compared to the same period in 2021, was primarily due to net unrealized and realized gains and losses on equity securities. Refer to Note 4-Investments and Note 5-Fair Value Measurements, to our consolidated financial statements for more information. Income Tax Expense Income tax expense was$223.3 million for the year endedDecember 31, 2022 , as compared to$118.1 million for the same period in 2021. For the years endedDecember 31, 2022 and 2021, our effective income tax rates (ETR) were approximately 23 percent and 20 percent, respectively. Our ETR for the year endedDecember 31, 2022 increased, as compared to our ETR for the year endedDecember 31, 2021 , primarily due to an increase in valuation allowance in the current year compared to a decrease in the prior year, and an increase in the reserve for uncertain tax positions, partially offset by an increase in excess tax benefits from share-based compensation. For additional details, refer to 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. InMarch 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, which matures in 2027, was$800.0 million and classified as a non-current liability in our consolidated balance sheets as ofDecember 31, 2022 . See Unsecured Revolving Credit Facilities below for further details.
For information regarding the fluctuation explanations between 2021 and 2020,
refer to our 2021 Annual Report.
Cash and Cash Equivalents and Marketable Investments
Cash and cash equivalents and marketable investments comprise the following (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2022 2021 2022 v. 2021 2022 v. 2021 Cash and cash equivalents$ 961.2 $ 894.8 $ 66.4 7 % Marketable investments-current 1,877.5 1,035.9 841.6 81 % Marketable investments-non-current 1,316.2 1,649.9 (333.7) (20) % Total cash and cash equivalents and marketable investments$ 4,154.9 $ 3,580.6 $ 574.3 16 % Cash Flows
Cash flows comprise the following (dollars in millions):
Year EndedDecember 31 , Dollar Change
Percentage Change
2022 2021 2020 2022 v. 2021 2021 v. 2020 2022 v. 2021 2021 v. 2020 Net cash provided by operating activities$ 802.5 $ 598.2 $ 755.7 $ 204.3 $ (157.5) 34 % (21) % Net cash used in investing activities$ (811.5) $ (486.9) $ (738.5) $ (324.6) $ 251.6 (67) % 34 % Net cash provided by (used in) financing activities$ 75.4 $ 44.8 $ (16.9) $ 30.6 $ 61.7 68 % 365 % 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$204.3 million in net cash provided by operating activities for the year endedDecember 31, 2022 , as compared to the year endedDecember 31, 2021 , was primarily due to: (1) a$105.0 million purchase of a pediatric disease priority review voucher during the year endedDecember 31, 2021 ; and (2) a$12.9 million decrease in cash paid to settle STAP awards. The remainder of the increase in cash provided by operating activities was due to other changes in assets and liabilities. 2022 Annual Report 53
--------------------------------------------------------------------------------
Investing Activities
The increase of$324.6 million in net cash used in investing activities for the year endedDecember 31, 2022 , as compared to the year endedDecember 31, 2021 , was primarily due to: (1) a$317.2 million increase in cash used for total purchases, sales, and maturities of marketable investments; and (2) a$18.0 million increase in cash paid to purchase property, plant, and equipment.
Financing Activities
The increase of$30.6 million in net cash provided by financing activities for the year endedDecember 31, 2022 , as compared to the year endedDecember 31, 2021 , was primarily due to a$38.4 million increase in proceeds from the exercise of stock options, partially offset by a$7.5 million increase in payments of debt issuance costs related to the 2022 Credit Agreement.
Unsecured Revolving Credit Facilities
InMarch 2022 , we entered into the 2022 Credit Agreement, which provides for unsecured revolving credit facilities of up to$2.0 billion in the aggregate. OnMarch 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). The aggregate balance of$800.0 million under our 2022 Credit Agreement remained outstanding as of bothDecember 31, 2022 andFebruary 22, 2023 . Refer to Note 7-Debt, to our consolidated financial statements.
Contractual Obligations
As ofDecember 31, 2022 , we had the following contractual obligations (in millions): Payments Due by Period Less than More than 5 Total 1 year 2-3 Years 4-5 Years Years Operating lease obligations$ 31.7
Long-term debt obligations(1)
1,014.2 50.4 100.8 863.0 - Obligations under the STAP(2) 76.4 76.4 - - - Obligations under the SERP(3) 67.7 19.5 18.1 - 30.1 Purchase obligations(4) 654.4 464.4 150.5 25.3 14.2 Total(5) (6)$ 1,844.4 $ 614.6 $ 276.4 $ 895.4 $ 58.0 (1)Long-term debt obligations include future principal and interest payments on our adjusted variable rate obligations under the 2022 Credit Agreement, assuming contractual maturity of the 2022 Credit Agreement. The 2022 Credit Agreement will mature inMarch 2027 . As ofDecember 31, 2022 , we have classified the entire$800.0 million outstanding balance as a non-current liability because we do not intend to repay any portion of this amount within one year. Refer to Note 7-Debt to our consolidated financial statements for further details. (2)Estimated based on the intrinsic value of exercisable outstanding STAP awards as ofDecember 31, 2022 . Refer to 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. Refer to 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. Refer to Note 12-Commitments and Contingencies to our consolidated financial statements for further details. (6)As ofDecember 31, 2022 , our other non-current liabilities in our consolidated balance sheets includes a liability of$15.9 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. Refer to Note 10-Income Taxes to our consolidated financial statements for further details.
54
--------------------------------------------------------------------------------
Obligations Under License Agreements
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 payThe 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. Refer to Note 12-Commitments and Contingencies to our consolidated financial statements for further details.
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. Refer to 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.
Summary of Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in conformity with generally accepted accounting principles inthe 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, Tyvaso DPI, 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, refer to 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 theU.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 ofDecember 31, 2022 and 2021, we had a liability of$81.3 million and$67.8 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 endedDecember 31, 2022 , 2021, and 2020. 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. 2022 Annual Report 55
--------------------------------------------------------------------------------
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.
LHC GROUP, INC – 10-K – Management's Discussion and Analysis of Financial Condition and Results of Operations.
Tens of thousands of Oregonians could lose free health care coverage
Advisor News
Annuity News
Health/Employee Benefits News
Life Insurance News