The following Management's Discussion and Analysis of Financial Condition and
Results of Operations ("MD&A") is intended to help the reader understand our
results of operations, cash flows and other changes in financial condition. MD&A
is provided as a supplement to, and should be read in conjunction with, our
audited consolidated financial statements and the accompanying notes to our
consolidated financial statements included in our Annual Report on Form 10-K.
This discussion may contain forward-looking statements based upon current
expectations that involve risks and uncertainties. Our actual results may differ
materially from those anticipated in these forward-looking statements as a
result of various factors, including those set forth in Special Note Regarding
Forward-Looking Statements and the section titled "Risk Factors" in Part I, Item
1A.
Royalty Pharma plc is a public limited company incorporated under the laws of
England and Wales that was created to facilitate the initial public offering
("IPO") of our Class A ordinary shares on June 16, 2020 . "Royalty Pharma ," the
"Company," "we," "us" and "our" refer to Royalty Pharma plc and its subsidiaries
on a consolidated basis.
Business Overview
We are the largest buyer of biopharmaceutical royalties and a leading funder of
innovation across the biopharmaceutical industry. Since our founding in 1996, we
have been pioneers in the royalty market, collaborating with innovators from
academic institutions, research hospitals and not-for-profits through small and
mid-cap biotechnology companies to leading global pharmaceutical companies. We
have assembled a portfolio of royalties which entitles us to payments based
directly on the top-line sales of many of the industry's leading therapies,
which includes royalties on more than 35 commercial products, including Vertex's
Trikafta, Kalydeco, Orkambi and Symdeko, Biogen's Tysabri, AbbVie and Johnson &
Johnson's Imbruvica, Astellas and Pfizer's Xtandi, GSK's Trelegy, Novartis'
Promacta, Pfizer's Nurtec ODT, Johnson & Johnson's Tremfya, Roche's Evrysdi,
Gilead's Trodelvy and 12 development-stage product candidates. We fund
innovation in the biopharmaceutical industry both directly and indirectly -
directly when we partner with companies to co-fund late-stage clinical trials
and new product launches in exchange for future royalties or milestones, and
indirectly when we acquire existing royalties from the original innovators.
Our capital-efficient business model enables us to benefit from many of the most
attractive characteristics of the biopharmaceutical industry, including long
product life cycles, significant barriers to entry and noncyclical revenues, but
with substantially reduced exposure to many common industry challenges such as
early stage development risk, therapeutic area constraints, high R&D costs, and
high fixed manufacturing and marketing costs. We have a highly flexible approach
that is agnostic to both therapeutic area and treatment modality, allowing us to
acquire royalties on the most attractive therapies across the biopharmaceutical
industry.
We classify our royalty acquisitions by the approval status of the therapy at the time of acquisition:
•Approved Products - We acquire royalties in approved products that generate predictable cash flows and may offer upside potential from unapproved indications. Since inception in 1996 through 2022, we have deployed$17.0 billion of cash to acquire royalties, milestones and related assets on approved products. From 2012 through 2022, we have deployed$12.1 billion to acquire royalties, milestones and related assets on approved products.
•Development-Stage Product Candidates - We acquire royalties on
development-stage product candidates that have demonstrated strong clinical
proof of concept. From 2012, when we began acquiring royalties on
development-stage product candidates, through 2022, we have deployed
While we classify our acquisitions in these two broad categories, several of our
approved product transactions are driven by the long-term expanded potential of
these existing commercial products in indications that are unapproved at the
time of acquisition. Similarly, some of our development-stage product candidate
transactions are specifically related to indications that are unapproved at the
time of acquisition, on products that are already approved and commercialized in
other indications.
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--------------------------------------------------------------------------------We acquire product royalties in ways that can be tailored to the needs of our partners through a variety of structures:
•Third-party Royalties - Existing royalties on approved or late-stage development therapies with high commercial potential. A royalty is the contractual right to a percentage of top-line sales from a licensee's use of a product, technology or intellectual property. The majority of our current portfolio consists of third-party royalties.
•Synthetic Royalties - Newly-created royalties on approved or late-stage
development therapies with strong proof of concept and high commercial
potential. A synthetic royalty is the contractual right to a percentage of
top-line sales by the developer or marketer of a therapy in exchange for
funding. A synthetic royalty may also include contingent milestone payments. We
also fund ongoing R&D for biopharmaceutical companies in exchange for future
royalties and milestones if the product or indication we are funding is
approved.
•Launch and Development Capital - Tailored supplemental funding solutions,
generally included as a component within a transaction, increasing the scale of
our capital. Launch and development capital is generally provided in exchange
for a long-term stream of fixed payments with a predetermined schedule around
the launch of a drug. Launch and development capital may also include a direct
investment in the public equity of a company.
•Mergers and Acquisitions ("M&A") Related - We acquire royalties in connection
with M&A transactions, often from the buyers of biopharmaceutical companies when
they dispose of the non-strategic assets of the target company following the
closing of the acquisition. We also seek to partner with companies to acquire
other biopharmaceutical companies that own significant royalties. We may also
seek to acquire biopharmaceutical companies that have significant royalties or
where we can create royalties in subsequent transactions.
Additionally, we may identify additional opportunities, platforms or technologies that leverage our capabilities such as our strategic alliance with MSCI Inc. ("MSCI") to develop thematic life science indexes.
Background and Format of Presentation
We consummated an exchange offer onFebruary 11, 2020 (the "Exchange Offer") to facilitate our IPO. Through the Exchange Offer, investors which represented 82% of the aggregate limited partnership interests in the various partnerships (the "Legacy Investors Partnerships") that owned Old RPI, exchanged their limited partnership interests in the Legacy Investors Partnerships for limited partnership interests inRPI US Partners 2019, LP, aDelaware limited partnership, orRPI International Holdings 2019, LP, aCayman Islands exempted limited partnership (together, the "Continuing Investors Partnerships"). The Exchange Offer together with (i) the concurrent incurrence of indebtedness under senior credit facilities and (ii) the issuance of additional interests in Continuing Investors Partnerships to satisfy performance payments payable in respect of assets acquired prior to the date of the IPO are referred to as the "Exchange Offer Transactions." Following our IPO, we operate and control the business affairs ofRP Holdings . We includeRP Holdings and its subsidiaries in our consolidated financial statements.RP Holdings is the sole owner of RPI 2019 ICAV, which is an Irish collective asset management entity. As a result of the Exchange Offer, we own indirectly an 82% economic interest in Old RPI through our subsidiary RPI 2019Intermediate Finance Trust , aDelaware statutory trust. We are entitled to 82% of the economics of Old RPI's wholly-owned subsidiaryRPI Finance Trust , aDelaware statutory trust ("RPIFT"), and 66% ofRoyalty Pharma Collection Trust , aDelaware statutory trust ("RPCT"). The remaining 34% of RPCT is owned by theLegacy Investors Partnerships and Royalty Pharma Select Finance Trust , aDelaware statutory trust ("RPSFT"), which is wholly owned by Royalty Pharma Select, an Irish unit trust. From the consummation of the Exchange Offer until the expiration of the Legacy Investors Partnerships' investment period onJune 30, 2020 (the "Legacy Date"), the Legacy Investors Partnerships could participate proportionately in any investment made by Old RPI. Following the Legacy Date, Old RPI ceased making new investments and each of the Legacy Investors Partnerships and Old RPI became legacy entities. Since the Legacy Date, we have made and plan to make new investments through our subsidiaries.
Following management's determination that a high degree of common ownership
existed in Old RPI both before and after the Exchange Offer,
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--------------------------------------------------------------------------------In 2022, we became an indirect owner of an 82% economic interest in Royalty Pharma Investments ICAV ("RPI ICAV"), which was previously owned directly by Old RPI.
Understanding Our Financial Reporting
Most of the royalties we acquire are treated as investments in cash flow streams and are classified as financial assets measured under the effective interest method in accordance with GAAP. Under this accounting methodology, we calculate the effective interest rate on each financial royalty asset using a forecast of the expected cash flows to be received over the life of the financial royalty asset relative to the initial acquisition price. The yield, which is calculated at the end of each reporting period and applied prospectively, is then recognized via accretion into our income at the effective rate of return over the expected life of the financial royalty asset. The measurement of income from our financial royalty assets requires significant judgments and estimates, including management's judgment in forecasting the expected future cash flows of the underlying royalties and the expected duration of the financial royalty asset. Our cash flow forecasts are updated each reporting period primarily using sell-side equity research analysts' consensus sales estimates for each of the products in which we own royalties. We then calculate our expected royalty cash flows using these consensus sales forecasts. In any given reporting period, any decline or increase in the expected future cash flows associated with a financial royalty asset is recognized in our income statement as non-cash provision expense or provision income, respectively. As a result of the non-cash charges associated with applying the effective interest method accounting methodology to our financial royalty assets, our consolidated income statement activity can be volatile and unpredictable. Small declines in sell-side equity research analysts' consensus sales forecasts over a long time horizon can result in an immediate non-cash income statement expense recognition which generates a corresponding cumulative allowance that reduces the gross asset balance, even though the applicable cash inflows will not be realized for many years into the future. For example, in late 2014, we acquired the cystic fibrosis franchise and beginning in the second quarter of 2015, declines in near-term sales forecasts of sell-side equity research analysts caused us to recognize non-cash provision expense in our consolidated income statements. Over the course of 10 quarters, we continued to recognize non-cash provision expense as a result of these changes in forecasts including non-cash provision expense of$743.2 million in 2016, ultimately reaching a peak cumulative allowance of$1.30 billion bySeptember 30, 2017 . With the approval of the Vertex triple combination therapy, Trikafta, inOctober 2019 , sell-side equity research analysts' consensus sales forecasts increased to reflect the larger addressable market and the extension of the expected duration of the Trikafta royalty. While small reductions in the cumulative allowance for the cystic fibrosis franchise were recognized as provision income over the course of 2017 and 2018, there remained a$1.10 billion cumulative allowance that was fully reduced by recognizing non-cash provision income of$1.10 billion in 2019 as a result of an increase in sell-side equity research analysts' consensus sales forecasts associated with the Trikafta approval. This example illustrates the volatility caused by our accounting model in our consolidated income statements. We believe there is no direct correlation between income from financial royalty assets and royalty receipts due to the nature of the accounting methodology applied for financial royalty assets. Further, income from financial royalty assets and the provision for changes in expected cash flows related to these financial royalty assets can be volatile and unpredictable. Our operations have historically been financed primarily with cash flows generated by our royalties. Given the importance of cash flows and their predictability to management's operation of the business, management uses royalty receipts as the primary measure of our operating performance. Royalty receipts refer to the summation of the following line items from our GAAP consolidated statements of cash flows: Cash collections from financial royalty assets, Cash collections from intangible royalty assets, Other royalty cash collections, Proceeds from available for sale debt securities and Distributions from equity method investees. In addition to analyzing our results on a GAAP basis, management also reviews our results on a non-GAAP basis. The closest comparable GAAP measure to each of the non-GAAP measures that management review is Net cash provided by operating activities. The key non-GAAP metrics we focus on are Adjusted Cash Receipts, Adjusted EBITDA and Adjusted Cash Flow, each of which is further discussed in the section titled "Non-GAAP Financial Results." Adjusted Cash Receipts and Adjusted Cash Flow are used by management as key liquidity measures in the evaluation of our ability to generate cash from operations. Both measures are an indication of our strength and the performance of the business. Management uses Adjusted Cash Flow to compare its performance against non-GAAP measures used by our peers in the biopharmaceutical industry. Adjusted EBITDA, which is derived from Adjusted Cash Receipts, is used by our lenders to assess our ability to meet our financial covenants. 53 --------------------------------------------------------------------------------
Refer to the section titled "Non-GAAP Reconciliations" for additional discussion of management's use of non-GAAP measures as supplemental financial measures.
Portfolio Overview
Our portfolio consists of royalties on more than 35 marketed therapies and 12
development-stage product candidates. The therapies in our portfolio address
therapeutic areas such as rare disease, cancer, neurology, infectious disease,
hematology and diabetes, and are delivered to patients across both primary and
specialty care settings. The table below includes royalty receipts for 2022 and
2021 in order of contributions to royalty receipts for 2022 (in thousands).
Royalty Receipts
Years Ended December 31,
Royalties Marketer(s) Therapeutic Area 2022 2021
Cystic fibrosis franchise (1) Vertex Rare disease $ 811,052 $ 702,140
Nurtec ODT/Biohaven payment (2) Pfizer Neurology 559,623 70,188 Tysabri Biogen Neurology 369,793 369,149 Imbruvica AbbVie, Johnson & Johnson Cancer 312,690 352,911 Xtandi Pfizer, Astellas Cancer 186,701 158,103 Promacta Novartis Hematology 181,632 173,621 Tremfya Johnson & Johnson Immunology 97,307 35,718 Trelegy GSK Respiratory 89,915 - Januvia, Janumet, Other DPP-IVs (3) Merck & Co., others Diabetes 72,943 151,158 Cabometyx/Cometriq Exelixis, Ipsen, Takeda Cancer 55,426 33,722 Farxiga/Onglyza AstraZeneca Diabetes 43,840 36,378 Evrysdi Roche Rare disease 40,645 16,098 Prevymis Merck & Co. Infectious disease 37,126 37,505 Trodelvy Gilead Cancer 24,809 13,395 Orladeyo BioCryst Rare disease 21,801 6,740 Erleada Johnson & Johnson Cancer 21,378 14,227 Crysvita Ultragenyx, Kyowa Kirin Rare disease 20,402 16,741 Emgality Lilly Neurology 18,832 15,481 Oxlumo Alnylam Rare disease 2,602 1,248 Other products (4) 262,739 404,019 Total royalty receipts$ 3,231,256 $ 2,608,542 (1)The cystic fibrosis franchise includes the following approved products: Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio. (2)Amounts include quarterly redemption payments of$15.6 million in 2021 and 2022 related to the Series A Biohaven Preferred Shares (presented as Proceeds from available for sale debt securities on the statements of cash flows). In 2022, amounts also include the accelerated redemption payments of$479.5 million for all outstanding Series A and Series B Biohaven Preferred Shares following Pfizer's acquisition of Biohaven inOctober 2022 . The remaining amounts are related to royalty receipts from Nurtec ODT. (3)Januvia, Janumet, Other DPP-IVs include the following approved products: Onglyza, Kombiglyze, Galvus, Eucreas and Nesina. The Other DPP-IVs are marketed by AstraZeneca, Novartis and Takeda. Our royalty receipts substantially ended in the second quarter of 2022. (4)Other products primarily include royalty receipts on the following products: Bosulif (a product co-developed by our joint venture investee, Avillion I, for which receipts are presented as Distributions from equity method investees on the statements of cash flows), Cimzia, Entyvio, Gavreto, HIV franchise, IDHIFA, Letairis, Lexiscan, Mircera, Myozyme, Nesina, Soliqua, Tazverik and distributions from the Legacy SLP Interest. Other products for 2021 include a one-time milestone payment of$45.0 million that we received on Soliqua. 54 --------------------------------------------------------------------------------
Financial Overview
Financial Highlights
•Net cash provided by operating activities totaled$2.1 billion and$2.0 billion for 2022 and 2021, respectively. Net cash provided by operating activities is the closest comparable GAAP financial measure to the supplemental non-GAAP liquidity measures that follow. •Adjusted Cash Receipts (a non-GAAP metric) totaled$2.8 billion and$2.1 billion for 2022 and 2021, respectively. •Adjusted EBITDA (a non-GAAP metric) totaled$2.6 billion and$1.9 billion for 2022 and 2021, respectively. •Adjusted Cash Flow (a non-GAAP metric) totaled$2.2 billion and$1.6 billion for 2022 and 2021, respectively.
Understanding Our Results of Operations
We report non-controlling interests related to the portion of ownership interests of consolidated subsidiaries not owned by us and which are attributable to:
1. The Legacy Investors Partnerships' ownership of approximately 18% of Old RPI
and Royalty Pharma Investments ICAV ("RPI ICAV"). The value of this
non-controlling interest will decline over time as the assets in Old RPI and RPI
ICAV expire.
2. A de minimis interest in RPCT held by RPSFT. The value of this
non-controlling interest was substantially eliminated as of
The Legacy Investors Partnership together with RPSFT are referred as the "legacy non-controlling interests." The legacy non-controlling interests are the only historical non-controlling interests that existed prior to our IPO.
Additionally, following the consummation of our IPO, we also report non-controlling interests related to:
3. The Continuing Investors Partnerships' ownership inRP Holdings through their ownership of RP Holdings ClassB Interests which was approximately 27% ofRP Holdings as ofDecember 31, 2022 . RP Holdings ClassB Interests are exchangeable into Class A ordinary shares. The value of this non-controlling interest will decline over time if the investors who indirectly own RP Holdings ClassB Interests conduct exchanges for our Class A ordinary shares.
The Continuing Investors Partnerships are referred as the "continuing non-controlling interests."
4.
EPA Holdings is entitled to receive Equity Performance Awards through its RP Holdings ClassC Special Interest. Equity Performance Awards owed toEPA Holdings will be recognized as an equity transaction when the obligation becomes due and will impact the income allocated to non-controlling interest related to the RP Holdings ClassC Special Interest. The Equity Performance Awards will be payable in RP Holdings ClassB Interests that will be exchanged upon issuance for Class A ordinary shares.EPA Holdings may also receive a periodic cash advance in respect of the RP Holdings ClassC Special Interest to the extent necessary forEPA Holdings or any of its beneficial owners to pay when due any income tax imposed on it or them as a result of holding such RP Holdings ClassC Special Interest. We do not currently expect any material Equity Performance Awards to be payable until certain performance conditions are met, which we do not expect to occur until the mid-2020s.
All of the results of operations of
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--------------------------------------------------------------------------------Total income and other revenues
Total income and other revenues is primarily comprised of income from our
financial royalty assets, royalty income generally arising from successful
commercialization of products developed through R&D funding arrangements, and a
declining contribution of royalty revenue from our intangible royalty assets for
which patent rights have materially expired. Most of our royalties are
classified as financial assets as our ownership rights are generally protective
and passive in nature. In instances in which we acquire a royalty that does
include more substantial rights or ownership of the underlying intellectual
property, we classify such royalties as intangible assets.
We recognize interest income related to our financial royalty assets. Royalty
revenue solely relates to our intangible royalty assets from our DPP-IV products
for which the patent rights are licensed to various counterparties. For 2022 and
2021, the royalty payors accounting for greater than 10% of our total income and
other revenues in any one year are shown in the table below:
Years Ended December 31,
Royalty Payor Royalty 2022 2021
Vertex Cystic fibrosis franchise 36 % 33 %
AbbVie Imbruvica 14 % 17 %
Income from financial royalty assets
Our financial royalty assets represent investments in cash flow streams with yield components that most closely resemble loans measured at amortized cost under the effective interest method. We calculate the effective interest rate using forecasted expected cash flows to be received over the life of the royalty asset relative to the initial acquisition price. Interest income is recognized at the effective rate of return over the expected life of the asset, which is calculated at the end of each reporting period and applied prospectively. As changes in sell-side equity research analysts' consensus sales estimates are updated on a quarterly basis, the effective rate of return changes. For example, if sell-side equity research analysts' consensus sales forecasts increase, the yield to derive income on a financial royalty asset will increase and result in higher income for subsequent periods. Variables affecting the recognition of interest income from financial royalty assets under the prospective effective interest method include any one of the following: (1) additional acquisitions, (2) changes in expected cash flows of the underlying pharmaceutical products, derived primarily from sell-side equity research analysts' consensus sales forecasts, (3) regulatory approval of additional indications which leads to new cash flow streams, (4) changes to the estimated duration of the royalty (e.g., patent expiration date) and (5) changes in amounts and timing of projected royalty receipts and milestone payments. Our financial royalty assets are directly linked to sales of underlying pharmaceutical products whose life cycle typically peaks at a point in time, followed frequently by declining sales trends due to the entry of generic competition, resulting in natural declines in the asset balance and periodic interest income over the life of our royalties. The recognition of interest income from royalties requires management to make estimates and assumptions around many factors, including those impacting the variables noted above.
Revenue from intangible royalty assets
Revenue from intangible royalty assets is derived from sales of Januvia, Janumet and other DPP-IV products by our licensees. Our royalties on Januvia and Janumet expired in the first quarter of 2022. Our royalties on other DPP-IV products have also substantially ended and we do not expect any material revenue from the other DPP-IV products in the future periods.
Other royalty income
Other royalty income primarily includes income from financial royalty assets
that have been fully amortized and income from synthetic royalties and
milestones arising out of R&D funding arrangements. Occasionally, a royalty
asset may be amortized on an accelerated basis due to collectability concerns,
which, if resolved, may result in future cash collections when no financial
royalty asset remains. Similarly, we may continue to collect royalties on a
fully amortized financial royalty asset beyond the estimated duration. In each
scenario where a financial royalty asset has been fully amortized, income from
such royalty is recognized as Other royalty income. Other royalty income also
includes income from royalties that are recorded at fair value on our
consolidated balance sheets.
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--------------------------------------------------------------------------------Provision for changes in expected cash flows from financial royalty assets
The Provision for changes in expected future cash flows from financial royalty assets includes the following:
•non-cash expense or income related to the current period activity resulting from adjustments to the cumulative allowance for changes in expected cash flows; and •non-cash expense or income related to the provision for current expected credit losses, which reflects the activity for the period, primarily due to new financial royalty assets with limited protective rights and changes to cash flow estimates for financial royalty assets with limited protective rights. As discussed above, income is accreted on our financial royalty assets using the effective interest method. As we update our forecasted cash flows on a periodic basis and recalculate the present value of the remaining future cash flows, any shortfall when compared to the carrying value of the financial royalty asset is recorded directly in the income statement through the line item Provision for changes in expected cash flows from financial royalty assets. If, in a subsequent period, there is an increase in expected cash flows or if actual cash flows are greater than cash flows previously expected, we reduce the cumulative allowance previously established for a financial royalty asset for the incremental increase in the present value of cash flows expected to be collected. This results in provision income (i.e., a credit to the provision).
The same variables and management's estimates affecting the recognition of interest income on our financial royalty assets noted above also directly impact the provision.
R&D funding expense R&D funding expense consists of payments that we have made to counterparties to acquire royalties or milestones on product candidates. It includes development-stage funding payments that are made upfront or upon pre-approval milestones, and development-stage funding payments that are made over time as the related product candidates undergo clinical trials with our counterparties.
General and administrative expenses
General and administrative ("G&A") expenses include primarily Operating and
Personnel Payments (defined below), legal expenses, other expenses for
professional services and share-based compensation. The expenses incurred in
respect of Operating and Personnel Payments are expected to comprise the most
significant component of G&A expenses on an ongoing basis.
Under the Management Agreement, we pay a quarterly operating and personnel
payment to the Manager or its affiliates ("Operating and Personnel Payments")
equal to 6.5% of the cash receipts from royalty investments for such quarter and
0.25% of the value of our security investments under GAAP as of the end of such
quarter.
The operating and personnel payments for Old RPI, an obligation of the Legacy
Investors Partnerships as a non-controlling interest in Old RPI and for which
the expense is reflected in G&A expenses, are calculated as the greater of $1
million per quarter and 0.3125% of royalties from Royalty Investments (as
defined in the limited partnership agreements of the Legacy Investors
Partnerships) during the previous twelve calendar months.
Equity in losses/(earnings) of equity method investees
Equity in losses/(earnings) of equity method investees primarily includes the results of our share of income or loss from the following non-consolidated affiliates:
1. Legacy SLP Interest
In connection with the Exchange Offer Transactions, we acquired an equity method investment from the Continuing Investors Partnerships in the form of a special limited partnership interest in the Legacy Investors Partnerships (the "Legacy SLP Interest") in exchange for issuing shares in our subsidiary. The Legacy SLP Interest entitles us to the equivalent of performance distribution payments that would have been paid to the general partner of the Legacy Investors Partnerships and a performance income allocation on a similar basis. As theLegacy Investors Partnerships no longer participate in investment opportunities, the value of the Legacy SLP Interest is expected to decline over time. 57 --------------------------------------------------------------------------------
2. The Avillion Entities
The Avillion Entities (as defined below) partner with global biopharmaceutical companies to perform R&D in exchange for success-based milestones or royalties if products are commercialized. Our investments inAvillion Financing I, LP ("Avillion I") andBAv Financing II, LP ("Avillion II" and, together with Avillion I, the "Avillion Entities") are accounted for using the equity method.
Other (income)/expenses, net
Other (income)/expenses, net primarily includes the changes in fair market value of our equity securities, derivative instruments and available for sale debt securities, including related forwards and funding commitments, and interest income.
Net income attributable to non-controlling interests
The net income attributable to non-controlling interests includes income attributable to the legacy non-controlling interests and the continuing non-controlling interests. As the Legacy Investors Partnerships and RPSFT no longer participate in investment opportunities, the related net income attributable to the legacy non-controlling interests is expected to decline over time. Net income attributable to the continuing non-controlling interests includes RP Holdings ClassB Interests held by the Continuing Investors Partnerships and will include net income attributable to the RP Holdings ClassC Special Interest held byEPA Holdings once certain performance conditions have been met. Future net income attributable to the non-controlling interest related toRP Holdings ClassB Interests held by the Continuing Investors Partnerships will decline over time if the investors who indirectly own RP Holdings ClassB Interests conduct exchanges for our Class A ordinary shares.
Net income attributable to non-controlling interests above can fluctuate significantly from period to period, primarily driven by volatility in the income statement activity of the respective underlying entity as a result of the non-cash charges associated with applying the effective interest accounting methodology to our financial royalty assets as described in section titled "Understanding Our Financial Reporting."
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--------------------------------------------------------------------------------Results of Operations
In this section, we discuss the results of our operations for 2022 compared to 2021. For a discussion of 2021 compared to 2020, please refer to Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 . The comparison of our historical results of operations for 2022 and 2021 are as follows (in thousands): Years Ended December 31, Change 2022 2021 $ % Income and other revenues Income from financial royalty assets$ 2,125,096 $ 2,065,083 $ 60,013 2.9 % Revenue from intangible royalty assets 37,484 171,248 (133,764) (78.1) % Other royalty income 74,635 53,132 21,503 40.5 % Total income and other revenues 2,237,215 2,289,463 (52,248) (2.3) % Operating expenses Provision for changes in expected cash flows from financial royalty assets 904,244 452,842 451,402 99.7 % Research and development funding expense 177,106 200,084 (22,978) (11.5) % Amortization of intangible assets 5,670 22,996 (17,326) (75.3) % General and administrative expenses 227,303 182,826 44,477 24.3 % Financial royalty asset impairment 615,827 - 615,827 n/a Total operating expenses, net 1,930,150 858,748 1,071,402 124.8 % Operating income 307,065 1,430,715 (1,123,650) (78.5) % Other expense/(income) Equity in losses of equity method investees 8,973 19,490 (10,517) (54.0) % Interest expense 187,961 166,142 21,819 13.1 % Other (income)/expenses, net (119,933) 3,882 (123,815) * Total other expenses, net 77,001 189,514 (112,513) (59.4) % Consolidated net income 230,064 1,241,201 (1,011,137) (81.5) % Net income attributable to non-controlling interests 187,232 621,473 (434,241) (69.9) %
Net income attributable to
619,728$ (576,896) (93.1) %
*Percentage change is not meaningful.
Total income and other revenues
Income from financial royalty assets
Income from financial royalty assets by top products for 2022 and 2021 is as follows, in order of contribution to income in 2022 (in thousands):
Years Ended December 31, Change
2022 2021 $ %
Cystic fibrosis franchise $ 808,947 $ 762,885 $ 46,062 6.0 %
Imbruvica 310,929 385,350 (74,421) (19.3) %
Tysabri 207,164 211,422 (4,258) (2.0) %
Tremfya 109,796 16,706 93,090 557.2 %
Xtandi 95,803 107,833 (12,030) (11.2) %
Promacta 88,395 73,372 15,023 20.5 %
Other 504,062 507,515 (3,453) (0.7) %
Total income from financial royalty assets
2.9 %
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Income from financial royalty assets increased by $60.0 million , or 2.9%, in
2022 compared to 2021, primarily driven by income from recently acquired assets,
including Tremfya and Trelegy, in addition to the strong performance of the
cystic fibrosis franchise primarily driven by the strong uptake of Kaftrio in
countries outside the United States and the performance of Trikafta in the
United States , including its uptake in children 6 through 11 years old. The
increase in income was partially offset by the maturing of our royalties from
the HIV franchise and declines in sell-side equity research analysts' consensus
sales forecasts for Imbruvica and Tazverik.
Revenue from intangible royalty assets
Revenue from intangible royalty assets decreased by
Other royalty income
Other royalty income increased by$21.5 million , or 40.5%, in 2022 compared to 2021, primarily related to growth in the ongoing product launches of Trodelvy and Nurtec ODT that arose from our R&D funding agreements with Immunomedics and Biohaven, respectively.
Provision for changes in expected cash flows from financial royalty assets
Provision activity is a combination of income and expense items. The provision
breakdown by royalty asset (exclusive of the provision for current expected
credit losses) based on the largest contributors to each year's provision income
or expense (in thousands) is as follows:
Royalty 2022 Royalty 2021
Imbruvica $ 423,832 Tazverik $ 210,567
Tysabri 195,665 Imbruvica 189,999
Tazverik 177,850 Emgality 68,716
Xtandi 63,524 Cystic fibrosis franchise 48,636
Evrysdi 46,077 Tysabri (96,103)
Other 191,094 Other 43,940
Total provision, exclusive of Total provision, exclusive of
provision for credit losses 1,098,042 provision for credit losses 465,755
Provision for current expected Provision for current expected
credit losses (193,798) credit losses (12,913)
Total provision $ 904,244 Total provision $ 452,842
In 2022, we recorded provision expense of $904.2 million , comprised of
$1,098.0 million and $193.8 million in provision expense for changes in expected
cash flows and provision income for current expected credit losses,
respectively. We recorded provision expense for changes in expected cash flows
for Imbruvica, Tysabri and Tazverik primarily due to significant declines in
sell-side equity research analysts' consensus sales forecasts. The provision
income for credit losses was primarily driven by a significant decrease in
current expected credit losses related to Tazverik as a result of the decline in
the financial asset value and changes in payors for certain products with
stronger credit profiles, which was partially offset by the addition of Trelegy
to our portfolio of financial royalty assets with limited protective rights.
In 2021, we recorded provision expense of $452.8 million , of which
$465.8 million and $12.9 million related to provision expense for changes in
expected cash flows and provision income for current expected credit losses,
respectively. We recorded provision expense for Tazverik, Imbruvica, Emgality
and the cystic fibrosis franchise, primarily due to significant declines in
sell-side equity research analysts' consensus sales forecasts. The provision
expense was partially offset by provision income from a significant increase in
sell-side equity research analysts' consensus sales forecasts for Tysabri. The
current expected credit loss activity in 2021 resulted in provision income that
was primarily driven by a significant decrease in current expected credit losses
related to Tazverik as a result of the corresponding significant decline in the
financial asset value. This was partially offset by provision expense for credit
losses recognized as a result of the increases to our portfolio of financial
royalty assets with limited protective rights, primarily related to zavegepant
from a $100.0 million funding payment that we made to Biohaven upon the start of
the oral zavegepant Phase 3 program and a new royalty interest in
Cabometyx/Cometriq.
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--------------------------------------------------------------------------------R&D funding expense
R&D funding expense decreased by$23.0 million , or 11.5%, in 2022 compared to 2021. In 2022, we recognized upfront R&D funding expense of$175.0 million in exchange for royalties and milestones on development-stage products from Cytokinetics, Incorporated ("Cytokinetics"), Theravance Biopharma, Inc ("Theravance") andMSD International Business GmbH ("Merck"). In 2021, we recognized upfront R&D funding expense of$193.2 million in exchange for royalties on development-stage products from BioCryst Pharmaceuticals, Inc. ("BioCryst") and MorphoSys AG ("MorphoSys").
G&A expenses
G&A expenses increased by$44.5 million , or 24.3%, in 2022 compared to 2021, primarily driven by higher Operating and Personnel Payments due to increased cash receipts from royalty investments.
Financial royalty asset impairment
Financial royalty asset impairment was$615.8 million in 2022 due to the recognition of non-cash impairment charges of$273.6 million ,$160.1 million and$182.1 million related to gantenerumab, otilimab and Gavreto, respectively. InNovember 2022 , Roche stated that it would discontinue clinical trials of gantenerumab. InOctober 2022 , GSK announced that it has decided not to progress with regulatory submissions for otilimab. These announcements contributed to our conclusion to impair these two assets. Additionally, during the fourth quarter of 2022, we impaired our financial royalty asset related to Gavreto due to the uncertainty of Gaverto's commercial outlook. There was no comparable activity in 2021.
Equity in losses of equity method investees
Equity in losses of equity method investees decreased by
Interest expense Interest expense increased by$21.8 million , or 13.1%, in 2022 compared to 2021, primarily driven by the issuance of$1.3 billion senior unsecured notes inJuly 2021 ("2021 Notes"). The weighted average coupon rate was 2.24% and 2.18% in 2022 and 2021, respectively.
Refer to the "Liquidity and Capital Resources" section for additional discussion of the Notes.
Other (income)/expenses, net Other income, net of$119.9 million in 2022 was primarily comprised of$96.6 million of gains on derivative financial instruments related to our Milestone Acceleration Option that increased in value with the announcement and subsequent completion of Pfizer's acquisition of Biohaven inOctober 2022 . In addition, we recorded$78.3 million of interest income, primarily related to the full accelerated redemption of our Series A Biohaven Preferred Shares following Pfizer's acquisition of Biohaven. The other income was partially offset by net losses on equity securities of$33.4 million . Other expense, net of$3.9 million in 2021 was primarily comprised of net losses on equity securities of$48.1 million , including losses on MorphoSys ordinary shares andEpizyme common stock, partially offset by a gain on Biohaven common shares; and losses of$21.5 million on our derivative financial instruments related to our treasury rate lock contracts that were unwound and settled in connection with the issuance of the 2021 Notes. The losses were partially offset by interest income of$50.9 million related to our Series A Biohaven Preferred Shares and a gain of$17.9 million on the unrealized change in fair value of our available for sale debt securities.
Net income attributable to non-controlling interests
Net income attributable to the Legacy Investors Partnerships decreased by$113.7 million in 2022 compared to 2021, primarily driven by lower net income attributable to Old RPI and RPI ICAV as a result of increased provision expense recognized in 2022. 61 -------------------------------------------------------------------------------- Net income attributable to the Continuing Investors Partnerships decreased by$273.5 million in 2022 compared to 2021, primarily driven by lower net income attributable toRP Holdings in 2022 as a result of increased provision expense and impairment charges recorded in 2022. Exchanges by investors in the Continuing Investors Partnerships who indirectly own RP Holdings ClassB Interests for our Class A ordinary shares resulted in a decline in the Continuing Investors Partnerships' ownership ofRP Holdings . Net income attributable to RPSFT decreased by$47.0 million in 2022 compared to 2021. We expect net income attributable to RPSFT to continue to decline as the assets held by RPCT mature.
Key Developments and Upcoming Events Relating to Our Portfolio
The key developments impacting our cash receipts and income and revenue from our royalty interests are discussed below:
Commercial Products
•Cystic fibrosis franchise. InApril 2021 , Vertex announced EC approval for Kaftrio in combination with ivacaftor for the treatment of patients with cystic fibrosis ages 12 and older who have at least one F508del mutation. InJune 2021 , Vertex announced that the FDA approved Trikafta for the treatment of children with cystic fibrosis ages 6 through 11 who have at least one F508del mutation or have certain mutations that are responsive to Trikafta based on in vitro data. InJanuary 2022 , Vertex announced that the EC granted approval for the label expansion of Kaftrio in combination with ivacaftor for the treatment of cystic fibrosis in patients ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. InNovember 2022 , Vertex announced the submission of a New Drug Application ("NDA") with the FDA for Trikafta in patients ages 2 through 5 years. Regulatory filings were also submitted with theEuropean Medicines Agency ("EMA") and the Medicines and Healthcare products Regulatory Agency. Vertex has indicated it expects an FDA decision on its Trikafta NDA patients ages 2 through 5 years in the second quarter of 2023, with a PDUFA target action date ofApril 28, 2023 .
•Tysabri. In
InAugust 2021 , Biogen announced results from Phase 3b NOVA study evaluation every six-week dosing with Tysabri intravenous administration in relapsing-remitting multiple sclerosis. Results show that every six-week Tysabri intravenous administration provides a high level of efficacy in controlling multiple sclerosis disease activity in patients who switched from the approved every four-week dosing regimen. •Imbruvica. InJune 2021 , Johnson & Johnson announced Phase 3 GLOW study results for fixed-duration Imbruvica in combination with Venetoclax demonstrated superior progression-free survival versus chlorambucil plus obinutuzumab as a first-line treatment of chronic lymphocytic leukemia. The study also showed improved duration of remission and significantly improved depth of remission. InAugust 2021 , AbbVie announced that theU.S. District Court for the District of Delaware had issued a decision holding patent rights relating to Imbruvica were valid and infringed by a generic product from Alvogen and Natco. The decision, which is subject to appeal, prohibits regulatory approval of that generic product until the last AbbVie patent expires. Previously, AbbVie entered into several settlement and license agreements with other generic companies. Consequently, AbbVie does not expect any generic product entry prior toMarch 30, 2032 , assuming pediatric exclusivity is granted. 62 -------------------------------------------------------------------------------- InJune 2022 , Johnson & Johnson announced primary results from the Phase 3 SHINE study, which demonstrated that the combination of once-daily oral Imbruvica plus bendamustine-rituximab (BR) and rituximab maintenance significantly reduced the risk of disease progression or death by 25% compared to patients who received placebo plus BR and rituximab maintenance in patients aged 65 years or older with newly diagnosed mantle cell lymphoma.
In
InAugust 2022 , Johnson & Johnson announced that the EC granted marketing authorization for the expanded use of Imbruvica in an all-oral, fixed-duration treatment combination with venetoclax for adults with previously untreated chronic lymphocytic leukemia. The approval is based on the pivotal Phase 3 GLOW study and the fixed-duration cohort of the Phase 2 CAPTIVATE study.
•Xtandi. In
InSeptember 2021 , Astellas and Pfizer announced that Xtandi plus androgen deprivation therapy reduced the risk of death by 34% compared to placebo plus androgen deprivation therapy in the Phase 3ARCHES study in men with metastatic hormone-sensitive prostate cancer. The primary results from theARCHES trial were published in 2019. InOctober 2022 , Pfizer announced positive top-line results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi compared to placebo plus Xtandi in men with metastatic castration-resistant prostate cancer. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival. The safety of Talzenna plus Xtandi was generally consistent with the known safety profile of each medicine. Pfizer intends to share data with global regulatory authorities to potentially support a regulatory filing. InFebruary 2023 , Astellas indicated that there could be a potential readout of the Phase 3 EMBARK trial for high-risk non-metastatic prostate cancer in the first quarter of 2023. •Nurtec ODT. InMay 2021 , Biohaven announced that the FDA approved Nurtec ODT for the preventative treatment of migraine, indicated for adult patients with episodic migraine who experience less than 15 headache days per month. InApril 2022 , Pfizer and Biohaven announced that the EC has granted marketing authorization for Vydura (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. InOctober 2022 , Pfizer acquired all outstanding shares of Biohaven not already owned by Pfizer for$148.50 per share in cash for a total of approximately$11.6 billion . Pfizer also made payments at closing to settle Biohaven's third-party debt and to redeem Biohaven's outstanding redeemable preferred shares. •Trodelvy. InApril 2021 , Gilead announced the FDA granted full approval to Trodelvy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study. InApril 2021 , Gilead announced that the FDA granted an accelerated approval of Trodelvy for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study. InJune 2021 , Gilead announced superior outcomes to standard of care in second-line treatment of metastatic TNBC in the Phase 3 ASCENT study. Trodelvy more than doubled overall survival as a second-line treatment in the new ASCENT subgroup analysis. 63 --------------------------------------------------------------------------------
In
InNovember 2021 , Gilead announced that the EC granted marketing authorization for Trodelvy as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.The EC's decision is supported by results from the Phase 3 ASCENT study, where Trodelvy reduced the risk of death by 49% and improved median overall survival to 11.8 months versus 6.9 months with physician's choice of chemotherapy. InJanuary 2022 , Gilead announced it has entered into two clinical trial collaboration and supply agreements with Merck & Co. to evaluate the combination of Trodelvy and Merck & Co.'s anti-PD-1 therapy Keytruda in first-line metastatic non-small cell lung cancer (NSCLC). As part of the collaboration, Merck & Co. will sponsor a global Phase 3 clinical trial of Trodelvy in combination with Keytruda as a first-line treatment of patients with metastatic NSCLC.
Additionally, Gilead and Merck & Co. established an agreement where Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC.
InJune 2022 , Gilead announced results from the primary analysis of the Phase 3 TROPiCS-02 study of Trodelvy versus physicians' choice of chemotherapy in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint of progression-free survival with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death. The first interim analysis of the key secondary endpoint of overall survival demonstrated a trend in improvement. Patients will be followed for a subsequent overall survival analysis. The safety profile for Trodelvy was consistent with prior studies. InSeptember 2022 , Gilead announced positive overall survival results from the Phase 3 TROPiCS-02 study evaluating Trodelvy versus comparator physicians' choice of chemotherapy in patients with HR+/HER2- metastatic breast cancer who received endocrine-based therapies and at least two chemotherapies. In the study, Trodelvy demonstrated a statistically significant and clinically meaningful improvement of 3.2 months in overall survival compared to chemotherapy. The TROPiCS-02 study met its primary endpoint of progression-free survival earlier this year, and demonstrated improved median progression-free survival in both HER2-low and IHC0 groups. InFebruary 2023 , Gilead announced theU.S. FDA approved Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. •Cabometyx. InJanuary 2021 , Exelixis announced that the FDA approved Cabometyx for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with Bristol Myers Squibb's Opdivo. The approval was based on the Phase 3 CheckMate -9ER trial, in which the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC.
In
InAugust 2021 , Exelixis announced that their partners Takeda and Ono received approval inJapan for Cabometyx in combination with Opdivo for the treatment of unresectable or metastatic RCC. InSeptember 2021 , Exelixis announced detailed results from the expanded Cohort 6 of the Phase 1b COSMIC-021 trial of Cabometyx in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer, which included patients with metastatic castration-resistant prostate cancer who had been previously treated with novel hormone therapies enzalutamide or abiraterone acetate used along with prednisone. Following discussions with FDA, Exelixis announced that it will not pursue a regulatory submission for the combination regimen based on cohort 6 of COSMIC-021. Exelixis believes that CONTACT-02, a global Phase 3 pivotal trial that initiated enrollment inJune 2020 may serve as a basis for future regulatory applications. 64 -------------------------------------------------------------------------------- InSeptember 2021 , Exelixis announced FDA approved Cabometyx for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. The approval was based on the Phase 3 COSMIC-311 pivotal trial. InMarch 2022 , Exelixis announced results from the final analysis of the second primary endpoint of overall survival from the Phase 3 COSMIC-312 trial, which evaluated cabozantinib in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma. The final analysis showed neither improvement nor detriment in overall survival for cabozantinib in combination with atezolizumab versus sorafenib. InMay 2022 , Ipsen announced that it received approval from the EC for Cabometyx as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy. InSeptember 2022 , Exelixis announced detailed results from COSMIC-313, an ongoing Phase 3 trial evaluating Cabometyx, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC, which met its primary endpoint, demonstrating significant improvement in progression-free survival at the primary analysis. At a prespecified interim analysis for the secondary endpoint of overall survival, the combination of Cabometyx, nivolumab and ipilimumab did not demonstrate a significant benefit. Following discussions with FDA, Exelixis does not intend to submit a supplemental NDA based on currently available data, but will plan to discuss a potential regulatory submission with FDA when results of the next overall survival analysis are available. InDecember 2022 , Exelixis announced that the Phase 3 CONTACT-01 study of Cabometyx in combination with atezolizumab versus docetaxel in patients with metastatic non-small cell lung cancer without actionable mutations who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy, did not meet its primary endpoint of overall survival at the final analysis. Detailed findings from CONTACT-01 are expected to be submitted for presentation at a future medical meeting. Exelixis has indicated it expects Phase 3 data in the first half of 2023 from CONTACT-03 in advanced or metastatic RCC and in the second half of 2023 from CONTACT-02 in metastatic castration-resistant prostate cancer. Additionally, the next overall survival analysis from COSMIC-313, the Phase 3 trial in advanced intermediate- or poor-risk RCC, is expected in 2023. •Evrysdi. InMarch 2021 , Roche announced that the EC approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four splicing modifier of motor neuron 2 copies.
In
InMay 2022 , Roche announced that the FDA has approved a label extension for Evrysdi to include infants under two months old with SMA. The approval is based on the interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic infants treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. •Orladeyo. InJanuary 2021 , Orladeyo was approved inJapan , becoming the first and only prophylactic hereditary angioedema (HAE) medication approved in the region.
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•Oxlumo. In July 2021 , Alnylam announced results from ILLUMINATE-C, a Phase 3
open-label study of lumasiran in patients of all ages with advanced primary
hyperoxaluria type 1 associated with progressive decline in renal function.
Results from the primary analysis at six months demonstrated a substantial
reduction in plasma oxalate from baseline in patients with advanced disease,
including those on hemodialysis. The safety and tolerability profile of
lumasiran following six months of treatment was encouraging across all ages,
with no drug related serious adverse events and injection site reactions as the
most common adverse event.
In March 2022 , the FDA accepted Alnylam's supplemental NDA for lumasiran for the
reduction of plasma oxalate in the treatment of patients with advanced primary
hyperoxaluria type 1. The FDA has set an action date for October 6, 2022 .
Additionally, a Type II Variation for lumasiran to amend the label in patients
with advanced primary hyperoxaluria Type 1 was submitted and validated by the
EMA in December 2021 .
In October 2022 , Alnylam announced that the FDA approved a label expansion for
Oxlumo, now indicated for the treatment of primary hyperoxaluria type 1 to lower
urinary oxalate and plasma oxalate levels in pediatric and adult patients. The
approval is based on positive efficacy and safety results of the ILLUMINATE-C
Phase 3 study of Oxlumo in patients with severe renal impairment, including
those on hemodialysis.
•Tremfya. In February 2022 , Johnson & Johnson announced results from the Phase
2a VEGA proof-of-concept study. Results showed that the combination of Tremfya
and golimumab, a tumor necrosis factor-alpha antagonist, induced higher rates of
clinical response, clinical remission, endoscopic improvement and a composite
histologic-endoscopic endpoint at 12 weeks than either treatment alone in adults
with moderately to severely active ulcerative colitis. Rates of adverse events
were comparable among treatment groups.
In February 2022 , Johnson & Johnson announced results from the Phase 2b QUASAR
Induction Study 1 in ulcerative colitis. Results showed that a significantly
greater proportion of adults with moderately to severely active ulcerative
colitis who previously had an inadequate response or intolerance to conventional
therapies or selected advanced therapies and were treated with Tremfya achieved
clinical response at week 12 (Tremfya 200 mg: 61.4% and Tremfya 400 mg: 60.7%),
the study's primary endpoint compared with placebo (27.6%). Safety data at week
12 was consistent with the safety profile for Tremfya in approved indications.
In October 2022 , Johnson & Johnson announced new results from the Phase 2b
QUASAR Induction Study 1. Results showed that continued treatment with Tremfya
in adults with moderately to severely active ulcerative colitis with inadequate
responses to previous treatments allowed a mean of 52.1% of IV Tremfya week 12
clinical nonresponders to achieve clinical response at week 24. Clinical
response at weeks 12 or 24 of the study was ultimately achieved by 80.2% of
patients who were randomized to IV Tremfya 200mg and by 78.5% of patients who
were randomized to IV Tremfya 400mg.
•Tazverik. In August 2022 , Ipsen completed its acquisition of Epizyme . Ipsen
acquired all the outstanding shares of Epizyme at a price of $1.45 per share
plus a contingent value right of $1 per share.
•Airsupra. In September 2021 , AstraZeneca and Avillion announced positive
results from MANDALA and DENALI, two Phase 3 trials evaluating Airsupra
(albuterol/budesonide), formerly known as PT027, in patients with asthma.
Airsupra is a potential first-in-class inhaled, fixed-dose combination of
albuterol, a short-acting beta2-agonist, and budesonide, an inhaled
corticosteroid. In MANDALA, Airsupra demonstrated a statistically significant
and clinically meaningful reduction in the risk of severe exacerbations compared
to albuterol, when used as a rescue medicine in response to symptoms. In DENALI,
Airsupra showed a statistically significant improvement in lung function
measured by forced expiratory volume in one second, compared to the individual
components albuterol and budesonide, and compared to placebo. The safety and
tolerability of Airsupra in both trials was consistent with the known profiles
of the components.
In May 2022 , Avillion LLP , a drug development company focused on the
co-development and financing of pharmaceutical candidates from proof-of-concept
through to regulatory approval, announced that FDA accepted for filing the NDA
for AstraZeneca's Airsupra. The proposed indication is for the as-needed
treatment or prevention of bronchoconstriction and for the prevention of
exacerbation of asthma. The co-development partnership between AstraZeneca and
Avillion also recently expanded to include the BATURA study, a randomized Phase
3b decentralized trial to further assess the role of Airsupra in preventing
asthma exacerbations.
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In
InJanuary 2023 , AstraZeneca announced theU.S. approval of Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.
Development-Stage Product Candidates
•Aficamten. In
InFebruary 2022 , Cytokinetics announced positive topline results from Cohort 3 of the REDWOOD-HCM Phase 2 trial. Results from Cohort 3 showed that substantial reductions in the average resting left ventricular outflow tract pressure gradient ("LVOT-G") as well as the post-Valsalva LVOT-G were achieved for patients with oHCM and a resting or post-Valsalva LVOT-G of greater than 50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. The safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators. •BCX10013. InJanuary 2023 , BioCryst announced that initial data from ongoing Phase 1 single ascending dose and multiple ascending dose trials in healthy volunteers showed rapid and sustained suppression of the alternative pathway of the complement system. BCX10013 was safe and generally well-tolerated at all doses studied to date. BioCryst plans to advance BCX10013 into patient studies in mid-2023, including in patients with paroxysmal nocturnal hemoglobinuria, to evaluate once-daily dosing. BioCryst expects to confirm the optimal dosing for pivotal trials by the end of the year, move directly into a pivotal trial in patients with immunoglobulin A nephropathy, and rapidly expand into pivotal trials in additional indications. •BCX9930. InDecember 2022 , BioCryst announced that it would discontinue the development of BCX9930 based on new competitive data recently presented at theAmerican Society of Hematology annual meeting. BioCryst will fully focus its complement inhibitor development efforts on BCX10013, a potential once-daily, oral Factor D inhibitor currently in clinical development. •Gantenerumab. InNovember 2022 , Roche stated that it would discontinue clinical trials of gantenerumab after the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer's disease did not meet their primary endpoint of slowing clinical decline. Roche continues to study trontinemab, its brain shuttle version of gantenerumab, in a Phase 2a study. •Omecamtiv mecarbil. InFebruary 2022 , Cytokinetics announced that the FDA has accepted and filed its NDA for omecamtiv mecarbil. The FDA assigned the NDA a standard review with a PDUFA date ofNovember 30, 2022 . The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application. The submission is supported by GALACTIC-HF, which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients with heart failure and reduced ejection fraction (HFrEF) who were receiving standard of care plus omecamtiv mecarbil. InFebruary 2022 , Cytokinetics announced results from METEORIC-HF, a Phase 3 trial evaluating the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity in patients with HFrEF. After 20 weeks of treatment, there was no change in peak oxygen uptake in patients treated with omecamtiv mecarbil versus placebo. InDecember 2022 , theU.S. FDA Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of HFrEF. The NDA for omecamtiv mecarbil is currently under review by the FDA, with a PDUFA target action date ofFebruary 28, 2023 . 67 -------------------------------------------------------------------------------- •Otilimab. InOctober 2022 , GSK announced that two of the three Phase trials met their primary endpoints, but the limited efficacy demonstrated in the ContRAst Phase 3 program did not support a suitable benefit/risk profile for otilimab as a potential treatment for rheumatoid arthritis. As a result, GSK decided not to progress with regulatory submissions. •Pelabresib. InDecember 2021 , MorphoSys presented data from the Phase 2 MANIFEST study evaluating pelabresib in the treatment of myelofibrosis. As ofSeptember 10, 2021 , the data cut-off, a total of 84 JAK inhibitor-naive patients were enrolled and received the first-line combination of pelabresib and ruxolitinib. The data showed 68% (n=57) of patients treated with the combination achieved a greater than or equal to 35% reduction in spleen volume from baseline at week 24 and 60% (n=47) maintained a greater than or equal to 35% reduction in spleen volume at week 48. Most patients also saw their symptoms reduced, with 56% (n=46) achieving greater than or equal to 50% reduction in total symptom score from baseline at week 24.
MorphoSys has indicated it expects topline data from the Phase 3 MANIFEST-2 study of pelabresib in myelofibrosis in early 2024.
•Tulmimetostat: InOctober 2022 , MorphoSys announced preliminary Phase 1/2 results of tulmimetostat, formerly known as CPI-0209, an oral, investigational next-generation selective dual inhibitor of EZH2 and EZH1, in heavily pretreated patients with advanced cancers. Results showed responses or disease stabilization in five cohorts with evaluable patients. The safety profile of tulmimetostat was consistent with the mechanism of action of EZH2 inhibition. •Zavegepant. InMarch 2021 , Biohaven announced that it enrolled the first patient in a Phase 2/3 clinical trial of oral zavegepant for the preventive treatment of migraine. Accordingly, per the agreement with Biohaven announced inAugust 2020 , we paid$100 million to Biohaven for the achievement of this milestone, bringing total zavegepant funding to$250 million . InOctober 2022 , Pfizer acquired Biohaven. Pfizer expects data from the trial in the third quarter of 2023. InDecember 2021 , Biohaven announced positive topline results from the second pivotal clinical trial evaluating the safety and efficacy of intranasal zavegepant for the acute treatment of migraine in adults. The Phase 3 study achieved its co-primary regulatory endpoints of pain freedom and freedom of most bothersome symptom at two hours and showed broad efficacy by demonstrating statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures.
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Non-GAAP Financial Results
In addition to analyzing our results on a GAAP basis, management also reviews
our results on a non-GAAP basis. As a result, management places importance on
royalty receipts as they are predictable and we use them as a measure of our
operating performance. Refer to section titled "Non-GAAP Reconciliations" for
additional discussion of management's use of non-GAAP measures as supplemental
financial measures and reconciliations from the most directly GAAP comparable
measures of Net cash provided by operating activities.
Adjusted Cash Receipts is a measure calculated with inputs directly from the
statements of cash flows and includes (1) total royalty receipts: (i) Cash
collections from royalty assets (financial assets and intangible assets), (ii)
Other royalty cash collections, (iii) Distributions from equity method
investees, plus (2) Proceeds from available for sale debt securities; less (1)
Distributions to legacy non-controlling interests - royalty receipts, which
represent contractual distributions of royalty receipts and proceeds from
available for sale debt securities to the Legacy Investors Partnerships and
RPSFT. Adjusted Cash Receipts is most directly comparable to the GAAP measure of
Net cash provided by operating activities.
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Adjusted EBITDA and Adjusted Cash Flow are similar non-GAAP liquidity measures
that are both most closely comparable to the GAAP measure, Net cash provided by
operating activities. Adjusted EBITDA is important to our lenders and is defined
under the Credit Agreement (defined below) as Adjusted Cash Receipts less
Payments for operating and professional costs. Payments for operating and
professional costs are comprised of Payments for operating and professional
costs and Payments for rebates from the statements of cash flows.
Adjusted Cash Flow is defined as Adjusted EBITDA less (1) Development-stage
funding payments - ongoing, (2) Development-stage funding payments - upfront and
milestone, (3) Interest paid, net of Interest received, (4) Investments in
equity method investees and (5) Other (including Derivative collateral posted,
net of Derivative collateral received, and Termination payments on derivative
instruments) plus (1) Contributions from legacy non-controlling interests - R&D,
all directly reconcilable to the statements of cash flows.
Adjusted Cash Receipts and Adjusted Cash Flow are used by management as key
liquidity measures in the evaluation of our ability to generate cash from
operations. Both measures are an indication of the strength of the Company and
the performance of the business. Management also uses Adjusted Cash Flow to
compare its performance against non-GAAP measures used by companies in the
biopharmaceutical industry. Adjusted EBITDA, as derived from Adjusted Cash
Receipts, is used by our lenders to assess our ability to meet our financial
covenants.
For a discussion of our cash flow results on a GAAP basis for 2022 and 2021,
refer to "Liquidity and Capital Resources." The following is a discussion of our
results on a non-GAAP basis for 2022 and 2021. For a discussion comparing our
results on a non-GAAP basis for 2021 and 2020, see "Management's Discussion and
Analysis of Financial Condition and Results of Operations" of our Annual Report
on Form 10-K for the fiscal year ended December 31, 2021 .
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The table below includes the royalty receipts and non-GAAP financial results for
2022 and 2021 by product in order of contribution to royalty receipts for 2022
(in thousands).
Years Ended December 31, Change
Royalties 2022 2021 $ %
Cystic fibrosis franchise (1) $ 811,052 $ 702,140 $ 108,912 15.5 %
Nurtec ODT/Biohaven payment (2) 559,623 70,188 489,435 *
Tysabri 369,793 369,149 644 0.2 %
Imbruvica 312,690 352,911 (40,221) (11.4) %
Xtandi 186,701 158,103 28,598 18.1 %
Promacta 181,632 173,621 8,011 4.6 %
Tremfya 97,307 35,718 61,589 172.4 %
Trelegy 89,915 - 89,915 n/a
Januvia, Janumet, Other DPP-IVs (3) 72,943 151,158 (78,215) (51.7) %
Cabometyx/Cometriq 55,426 33,722 21,704 64.4 %
Farxiga/Onglyza 43,840 36,378 7,462 20.5 %
Evrysdi 40,645 16,098 24,547 152.5 %
Prevymis 37,126 37,505 (379) (1.0) %
Trodelvy 24,809 13,395 11,414 85.2 %
Orladeyo 21,801 6,740 15,061 223.5 %
Erleada 21,378 14,227 7,151 50.3 %
Crysvita 20,402 16,741 3,661 21.9 %
Emgality 18,832 15,481 3,351 21.6 %
Oxlumo 2,602 1,248 1,354 108.5 %
Other products (4) 262,739 404,019 (141,280) (35.0) %
Total royalty receipts $ 3,231,256 $ 2,608,542 $ 622,714 23.9 %
Distributions to legacy non-controlling (7.8) %
interests - royalty receipts (441,963) (479,604) 37,641
Adjusted Cash Receipts (non-GAAP) $ 2,789,293 $ 2,128,938 $ 660,355 31.0 %
Payments for operating and professional costs (222,969) (184,511) (38,458) 20.8 %
Adjusted EBITDA (non-GAAP) $ 2,566,324 $ 1,944,427 $ 621,897 32.0 %
Development-stage funding payments - ongoing (2,106) (6,876) 4,770 (69.4) %
Development-stage funding payments - upfront (9.4) %
and milestone (175,000) (193,208) 18,208
Interest paid, net (145,157) (127,295) (17,862) 14.0 %
Investments in equity method investees (9,896) (34,855) 24,959 (71.6) %
Contributions from legacy non-controlling (85.6) %
interests - R&D 1,059 7,339 (6,280)
Other - (16,093) 16,093 (100.0) %
Adjusted Cash Flow (non-GAAP) $ 2,235,224 $ 1,573,439 $ 661,785 42.1 %
Fully diluted Class A ordinary shares
outstanding 607,224 607,176
*Percentage change is not meaningful.
(1)The cystic fibrosis franchise includes the following approved products: Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio. (2)Amounts include quarterly redemption payments of$15.6 million in 2021 and 2022 related to the Series A Biohaven Preferred Shares (presented as Proceeds from available for sale debt securities on the statements of cash flows). In 2022, amounts also include the accelerated redemption payments of$479.5 million for all outstanding Series A and Series B Biohaven Preferred Shares following Pfizer's acquisition of Biohaven inOctober 2022 . The remaining amounts are related to royalty receipts from Nurtec ODT. (3)Januvia, Janumet, Other DPP-IVs include the following approved products: Onglyza, Kombiglyze, Galvus, Eucreas and Nesina. The Other DPP-IVs are marketed by AstraZeneca, Novartis and Takeda. Our royalty receipts substantially ended in the second quarter of 2022. (4)Other products primarily include royalty receipts on the following products: Bosulif (a product co-developed by our joint venture investee, Avillion I, for which receipts are presented as Distributions from equity method investees on the statements of cash flows), Cimzia, Entyvio, Gavreto, HIV franchise, IDHIFA, Letairis, Lexiscan, Mircera, Myozyme, Nesina, Soliqua, Tazverik and distributions from the Legacy SLP Interest. Other products for 2021 include a one-time milestone payment of$45.0 million that we received on Soliqua. 70 --------------------------------------------------------------------------------
Adjusted Cash Receipts (non-GAAP)
Adjusted Cash Receipts increased by$660.4 million to$2.8 billion in 2022 compared to 2021, primarily driven by the accelerated redemption of all outstanding Series A and Series B Biohaven Preferred Shares received following Pfizer's acquisition of Biohaven inOctober 2022 . We also saw an increase in royalty receipts from the cystic fibrosis franchise and new assets acquired in 2022, primarily Trelegy. The increase was partially offset by a decline in royalty receipts from maturing royalties, such as the HIV franchise and Januvia, Janumet and other DPP-IVs, as well as unfavorable foreign exchange movements. The increase in Adjusted Cash Receipts was further driven by a decrease in distributions of royalty receipts to legacy non-controlling interests due to maturing royalties jointly owned by the Legacy Investors Partnerships and RPSFT.
Below we discuss the key drivers of royalty receipts.
Royalty Receipts
•Cystic fibrosis franchise - Royalty receipts from the cystic fibrosis franchise, which includes Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio, which are marketed by Vertex for patients with certain mutations causing cystic fibrosis, increased by$108.9 million in 2022 compared to 2021. The increase was primarily driven by the strong uptake of Kaftrio in countries outsidethe United States and the performance of Trikafta inthe United States , including its uptake in children 6 through 11 years old. •Nurtec ODT/Biohaven payment - Royalty receipts from Nurtec ODT, which is marketed by Pfizer for the acute treatment of migraine, were$17.6 million and the redemption payments on Biohaven Series A and Series B Preferred Shares were$542.0 million in 2022. The increase of$9.9 million in royalty receipts from Nurtec ODT compared to 2021 was driven by strong volume growth. The increase of$479.5 million in redemption payments compared to 2021 was driven by the accelerated redemption payments for all outstanding Series A and Series B Preferred Shares following Pfizer's acquisition of Biohaven inOctober 2022 . •Tysabri - Royalty receipts from Tysabri, which is marketed by Biogen for the treatment of multiple sclerosis, were relatively consistent in 2022 compared to 2021. •Imbruvica - Royalty receipts from Imbruvica, which is marketed by AbbVie and Johnson & Johnson for the treatment of blood cancers and chronic graft versus host disease, decreased by$40.2 million in 2022 compared to 2021. The decrease was largely due to increased competition in the chronic lymphocytic leukemia market and a decrease in new patient starts inthe United States relative to pre-COVID levels.
•Xtandi - Royalty receipts from Xtandi, which is marketed by Pfizer and Astellas
for the treatment of prostate cancer, increased by
•Promacta - Royalty receipts from Promacta, which is marketed by Novartis for
the treatment of chronic immune thrombocytopenia (ITP) and aplastic anemia,
increased by
•Tremfya - Royalty receipts from Tremfya, which is marketed by Johnson & Johnson for the treatment of plaque psoriasis and active psoriatic arthritis, increased by$61.6 million in 2022 compared to 2021. The increase was largely driven by market growth and continued market share gains. We acquired the Tremfya royalty inJuly 2021 and we began to record royalty receipts in the third quarter of 2021. •Trelegy - Royalty receipts from Trelegy, which is marketed by GSK for the maintenance treatment of chronic obstructive pulmonary disease and asthma, were$89.9 million in 2022, primarily due to strong patient demand across all regions and growth of the single inhaler triple therapy market. We acquired the Trelegy royalty inJuly 2022 and we began to record royalty receipts in the third quarter of 2022. •Januvia, Janumet, Other DPP-IVs - Royalty receipts from the DPP-IVs for type 2 diabetes, which include Januvia and Janumet, both marketed by Merck & Co., decreased by$78.2 million in 2022 compared to 2021. Royalty receipts from Januvia, Janumet and other DPP-IVs substantially ended in the second quarter of 2022. 71 -------------------------------------------------------------------------------- •Cabometyx/Cometriq - Royalty receipts from Cabometyx/Cometriq, which is marketed by Exelixis, Ipsen and Takeda, increased by$21.7 million in 2022 compared to 2021. The increase was primarily due to the uptake of Cabometyx in combination with Opdivo as a first-line treatment for patients with advanced renal cell carcinoma, including longer duration of therapy. We acquired the Cabometyx/Cometriq royalty inMarch 2021 and we began to record royalty receipts in the second quarter of 2021.
Distributions to legacy non-controlling interests - royalty receipts
Distributions of royalty receipts to legacy non-controlling interests decreased by$37.6 million to$442.0 million in 2022 compared to 2021, which positively impacted Adjusted Cash Receipts. The decrease in distributions of royalty receipts to legacy non-controlling interests is primarily due to maturing royalties jointly owned by the Legacy Investors Partnerships and RPSFT. Partially offsetting these decreases was a distribution to legacy non-controlling interests related to the accelerated redemption of all outstanding Biohaven Series A Preferred Shares that we received following Pfizer's acquisition of Biohaven inOctober 2022 .
Adjusted EBITDA (non-GAAP)
Adjusted EBITDA increased by$621.9 million to$2.6 billion in 2022 compared to 2021 as a result of the factors noted above in "Adjusted Cash Receipts (non-GAAP)." The increase was partially offset by payments for operating and professional costs, the only adjustment between Adjusted Cash Receipts and Adjusted EBITDA, which increased in 2022 as our Operating and Personnel Payments are a fixed percentage of 6.5% of cash receipts from our royalties.
Adjusted Cash Flow (non-GAAP)
Adjusted Cash Flow increased by$661.8 million to$2.2 billion in 2022 compared to 2021 primarily for the same reasons noted above in "Adjusted Cash Receipts (non-GAAP)" and "Adjusted EBITDA (non-GAAP)."
Non-GAAP Reconciliations
Adjusted Cash Receipts, Adjusted EBITDA and Adjusted Cash Flow are non-GAAP
measures presented as supplemental measures to our GAAP financial performance.
These non-GAAP financial measures exclude the impact of certain items and
therefore have not been calculated in accordance with GAAP. In each case,
because our operating performance is a function of our liquidity, the non-GAAP
measures used by management are presented and defined as supplemental liquidity
measures. We caution readers that amounts presented in accordance with our
definitions of Adjusted Cash Receipts, Adjusted EBITDA and Adjusted Cash Flow
may not be the same as similar measures used by other companies. Not all
companies and analysts calculate the non-GAAP measures we use in the same
manner. We compensate for these limitations by using non-GAAP financial measures
as supplements to GAAP financial measures and by presenting the reconciliations
of the non-GAAP financial measures to their most comparable GAAP financial
measures, in each case being Net cash provided by operating activities.
We believe that Adjusted Cash Receipts and Adjusted Cash Flow provide meaningful
information about our operating performance because the business is heavily
reliant on its ability to generate consistent cash flows and these measures
reflect the core cash collections and cash charges comprising our operating
results. Management strongly believes that our significant operating cash flow
is one of the attributes that attracts potential investors to our business.
In addition, we believe that Adjusted Cash Receipts and Adjusted Cash Flow help
identify underlying trends in the business and permit investors to more fully
understand how management assesses our performance, including planning and
forecasting for future periods. Adjusted Cash Receipts and Adjusted Cash Flow
are used by management as key liquidity measures in evaluating our ability to
generate cash from operations. Both measures are an indication of our strength
and the performance of the business. Management uses Adjusted Cash Receipts and
Adjusted Cash Flow when considering available cash, including for
decision-making purposes related to funding of acquisitions, voluntary debt
repayments, dividends and other discretionary investments. Further, these
non-GAAP financial measures help management, the audit committee and investors
evaluate our ability to generate liquidity from operating activities.
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Management believes that Adjusted EBITDA is an important non-GAAP measure in
analyzing our liquidity and is a key component of certain material covenants
contained within our Credit Agreement (defined below). Noncompliance with the
interest coverage ratio and leverage ratio covenants under the Credit Agreement
(defined below) could result in our lenders requiring us to immediately repay
all amounts borrowed. If we cannot satisfy these financial covenants, we would
be prohibited under our Credit Agreement (defined below) from engaging in
certain activities, such as incurring additional indebtedness, paying dividends,
making certain payments and acquiring and disposing of assets. Consequently,
Adjusted EBITDA is critical to the assessment of our liquidity.
Management uses Adjusted Cash Flow to evaluate its ability to generate cash from
operations, the performance of the business and our performance as compared to
its peer group. Management also uses Adjusted Cash Flow to compare its
performance against non-GAAP measures used by many companies in the
biopharmaceutical industry, even though each company may customize its own
calculation and therefore one company's metric may not be directly comparable to
another's. We believe that non-GAAP financial measures, including Adjusted Cash
Flow, are frequently used by securities analysts, investors and other interested
parties to evaluate companies in our industry.
The non-GAAP financial measures used in this Annual Report on Form 10-K have
limitations as analytical tools, and you should not consider them in isolation
or as a substitute for the analysis of our results as reported under GAAP. We
have provided a reconciliation of each non-GAAP financial measure to the most
directly comparable GAAP financial measure, in each case being Net cash provided
by operating activities below.
To arrive at Adjusted Cash Receipts, we start with the GAAP line item, Net cash
provided by operating activities, and adjust for the following items from the
statements of cash flows: to add back (1) Proceeds from available for sale debt
securities (redemption of Biohaven Preferred Shares), which are cash inflows
that management believes are derived from royalties and form part of our core
business strategy, (2) Distributions from equity method investees which are
classified as cash inflows from investing activities (3) Interest paid, net of
Interest received, (4) Development-stage funding payments, (5) Payments for
operating and professional costs, (6) Payments for rebates and (7) Termination
payments on derivative instruments, and to deduct (1) Distributions to legacy
non-controlling interests - royalty receipts, which represents distributions to
the Legacy Investors Partnerships and RPSFT and (2) Derivative collateral posted
or (received), net, both of which are excluded when management assesses its
operating performance through cash collections, or, Adjusted Cash Receipts.
To arrive at Adjusted EBITDA, we start with Net cash provided by operating
activities and adjust for the following items from the statements of cash flows:
to add back (1) Proceeds from available for sale debt securities (redemption of
Biohaven Preferred Shares), (2) Distributions from equity method investees which
are classified as cash inflows from investing activities, (3) Interest paid, net
of Interest received, (4) Development-stage funding payments and (5) Termination
payments on derivative instruments, and to deduct (1) Distributions to legacy
non-controlling interests - royalty receipts and (2) Derivative collateral
posted or (received), net.
To arrive at Adjusted Cash Flow, we start with Net cash provided by operating
activities and adjust for the following items from the statements of cash flows:
to add back (1) Proceeds from available for sale debt securities (redemption of
Biohaven Preferred Shares), (2) Distributions from equity method investees
classified as cash inflows from investing activities, and (3) Contributions from
legacy non-controlling interests - R&D, and to deduct (1) Distributions to
legacy non-controlling interests - royalty receipts and (2) Investments in
equity method investees. This is intended to present an Adjusted Cash Flow
measure that is representative of cash generated from the broader business
strategy of acquiring royalty-generating assets that are available for
reinvestment and for discretionary purposes.
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(in thousands) Years Ended December 31,
2022 2021
Cash flow data (GAAP basis)
Net cash provided by (used in):
Operating activities $ 2,143,980 $ 2,017,536
Investing activities (1,029,421) (1,870,280)
Financing activities (944,856) 385,112
Net cash provided by operating activities (GAAP) $ 2,143,980 $ 2,017,536
Adjustments:
Proceeds from available for sale debt securities (1), (2) 542,044 62,500
Distributions from equity method investees (2) - 523
Interest paid, net (2) 145,157 127,295
Development-stage funding payments - ongoing (3) 2,106 6,876
Development-stage funding payments - upfront and milestone (3) 175,000
193,208
Payments for operating and professional costs 222,969 184,511
Termination payments on derivative instruments - 16,093
Distributions to legacy non-controlling interests - royalty (441,963) (479,604)
receipts (2)
Adjusted Cash Receipts (non-GAAP) $
2,789,293
Net cash provided by operating activities (GAAP)$ 2,143,980 $ 2,017,536 Adjustments: Proceeds from available for sale debt securities (1), (2) 542,044 62,500 Distributions from equity method investees (2) - 523 Interest paid, net (2) 145,157 127,295 Development-stage funding payments - ongoing (3) 2,106 6,876
Development-stage funding payments - upfront and milestone (3) 175,000
193,208
Termination payments on derivative instruments - 16,093
Distributions to legacy non-controlling interests - royalty (441,963) (479,604)
receipts (2)
Adjusted EBITDA (non-GAAP) $
2,566,324
Net cash provided by operating activities (GAAP)$ 2,143,980 $ 2,017,536 Adjustments: Proceeds from available for sale debt securities (1), (2) 542,044 62,500 Distributions from equity method investees (2) - 523 Distributions to legacy non-controlling interests - royalty (441,963) (479,604) receipts (2) Investments in equity method investees (2), (4) (9,896) (34,855) Contributions from legacy non-controlling interests - R&D (2) 1,059 7,339 Adjusted Cash Flow (non-GAAP) $
2,235,224
(1)Receipts from the quarterly redemption of the Series A Biohaven Preferred Shares in 2021 and 2022 and the accelerated redemption payments of all outstanding Series A and Series B Preferred Shares following Pfizer's acquisition of Biohaven inOctober 2022 are presented as Proceeds from available for sale debt securities on the statements of cash flows. (2)The table below shows the line item for each adjustment and the direct location for such line item on the statements of cash flows. Reconciling Adjustment Statements of Cash Flows Classification Proceeds from available for sale debt securities Investing activities Investments in equity method investees Investing
activities
Distributions to legacy non-controlling interests - royalty receipts Financing
activities
Operating activities (Interest paid less Interest
Interest paid, net received)
Contributions from legacy non-controlling
interests - R&D Financing activities
Distributions from equity method investees Investing
activities
74
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(3)Our lenders consider all payments made to support R&D activities for
development-stage product candidates similar to asset acquisitions as these
funds are expected to generate operational returns in the future. All ongoing
development-stage funding payments and upfront and milestone development-stage
funding payments are reported as R&D funding expense in net income and are added
back in aggregate to Net cash provided by operating activities to arrive at
Adjusted EBITDA. As a result, Adjusted EBITDA captures the full add-back for
development-stage funding payments.
(4)We consider all payments to fund our operating joint ventures that are
performing R&D activities for development-stage product candidates similar to
asset acquisitions as these funds are expected to generate operational returns
in the future. As a result, amounts funded through capital calls by our equity
method investees, the Avillion Entities, are deducted to arrive at Adjusted Cash
Flow, but are not deducted in Adjusted EBITDA.
Investments Overview
Ongoing investment in new royalties is fundamental to the long-term prospects of our business. New investments provide a source of growth for our royalty receipts, supplementing growth within our existing portfolio and offsetting declines for royalties on products that have lost market exclusivity. We evaluate an array of royalty acquisition opportunities on a continuous basis and expect to continue to make acquisitions in the ordinary course of our business. We have established a strong track record of identifying, evaluating and investing in royalties tied to leading products across therapeutic areas and treatment modalities. We invest in approved products and development-stage product candidates that have generated robust proof of concept data. We invest in these therapies through the purchase of royalties, milestones and related assets, by making hybrid investments and by acquiring businesses with significant existing royalty assets or the potential for the creation of such assets. In 2022, we invested$2.5 billion to acquire royalties, milestones and related assets. While volatility exists in the total amount of our new acquisitions on a year-to-year basis due to the unpredictable timing of new investment opportunities, we have consistently deployed significant amounts of cash when measured over multi-year periods. Our approach is rooted in a highly disciplined evaluation process that is not dictated by a minimum annual investment threshold. Included below are tables of investment activities over each of the last three years based on the type of investment at the acquisition date (in thousands). Announced transactions amounts reflect maximum transaction value for transactions entered into over each of the last three years. Capital deployed amounts reflect cash paid at the acquisition date and any subsequent associated contractual payments reflected in the period in which cash was paid. Average 2022 2021 2020 Announced Transactions Upfront payments$ 2,132,667 $ 2,022,000 $ 2,307,000 $ 2,069,000 Potential payments/milestones 840,833 1,442,500 705,000 375,000 Total announced transaction value$ 2,973,500 $ 3,464,500 $ 3,012,000 $ 2,444,000 Capital Deployed Approved/marketed royalties$ 1,726,360 $ 1,954,957 $ 1,819,903 $ 1,404,221 Development-stage royalties (1) 762,475 562,244 830,713 894,469 Total capital deployed$ 2,488,835 $ 2,517,201 $ 2,650,616 $ 2,298,690
(1)Development-stage royalties include: direct R&D funding arrangements and funding arrangements executed through our joint venture partnership with the Avillion Entities, investments in development-stage product candidates and investments in securities primarily made in connection with acquisitions of royalties on development-stage products from the seller.
Summary of Royalty Acquisition Activity
•InJanuary 2023 , we acquired royalty interests in Spinraza and pelacarsen from Ionis for an upfront payment of$500 million and committed up to$625 million in additional payments contingent upon the achievement of certain pelacarsen milestones. Spinraza is approved for the treatment of spinal muscular atrophy and pelacarsen is in Phase 3 development by Novartis for the treatment of cardiovascular disease. •InNovember 2022 , we acquired a royalty interest in olpasiran from Arrowhead Pharmaceuticals for an upfront payment of$250 million and certain contingent clinical, regulatory, and sales-based milestones of up to$160 million . Olpasiran is currently in Phase 3 development for the treatment of atherosclerotic cardiovascular disease and is licensed to Amgen. 75 -------------------------------------------------------------------------------- •InOctober 2022 , we entered into a R&D funding agreement with Merck to co-fund the development of MK-8189, an investigational oral PDE10A inhibitor currently being evaluated in a Phase 2b study for the treatment of schizophrenia. We funded$50 million upon closing, and if Merck decides to proceed with Phase 3, we have the option to fund up to an additional$375 million . In exchange, we are eligible to receive milestone payments associated with certain regulatory approvals as well as royalties on annual worldwide sales of any approved product. •InJuly 2022 , we acquired all of the equity interests inTheravance Respiratory Company, LLC fromTheravance and Innoviva, Inc. which entitles us to the right to receive royalties on the annual worldwide sales of Trelegy for an upfront payment of$1.31 billion and up to$300 million in additional payments contingent upon the achievement of certain sales milestones. Additionally, we agreed to provide Theravance$25 million in upfront funding and a potential$15 million regulatory milestone payment to support the clinical development of ampreloxetine. •InJune 2022 , we acquired an ex-U.S. royalty interest in Gavreto from Blueprint Medicines for an upfront payment of$175 million and contingent sales-based milestones up to$165 million . During the fourth quarter of 2022, we impaired our financial royalty asset related to Gavreto and recorded a non-cash impairment charge of$182.1 million .
•In
•InJanuary 2022 , we acquired a royalty interest in aficamten, a development-stage product for oHCM, for an upfront payment of$50 million and two additional contingent$50 million payments which are triggered upon the initiation of potential pivotal clinical trials for oHCM and nonobstructive hypertrophic cardiomyopathy, respectively. InFebruary 2022 , one of the$50 million contingent milestone payments was triggered following Cytokinetics' announcement that it initiated the clinical trial for oHCM. Additionally, we entered into a funding agreement to provide Cytokinetics long-term capital of up to$300 million ("Cytokinetics Commercial Launch Funding") to support further development of aficamten and potential commercialization of omecamtiv mecarbil, both development-stage products. The Cytokinetics Commercial Launch Funding is available in five tranches, including an initial tranche of$50 million that was funded upon closing. InJune 2022 , we amended the funding agreement to increase the required draw amount and further amended the funding agreement inDecember 2022 to extend the draw periods and increase the repayments terms of the second and third tranche. •InNovember 2021 , we acquired incremental royalty interests in BCX9930 and Orladeyo (berotralstat) from BioCryst for an upfront cash payment of$150 million . Additionally, we paid$50 million to purchase 3,846 thousand shares of BioCryst common stock, which was calculated based on the volume-weighted average price of BioCryst common stock over a period preceding the closing of the transaction. •InJune 2021 , we announced a long-term strategic funding partnership with MorphoSys to support its acquisition ofConstellation Pharmaceuticals, Inc. ("Constellation"), which closed onJuly 15, 2021 . We agreed to provide up to$2.025 billion of funding to MorphoSys, comprised of an upfront payment of$1.425 billion , additional milestone payments of up to$150 million , up to$350 million of capital ("Development Funding Bonds") in exchange for royalties and fixed payments on the Development Funding Bonds, once drawn. In connection with the closing of its acquisition of Constellation, we purchased 1,337,552 ordinary shares of MorphoSys for$100 million at a price of €63.35 per ordinary share, based on the average trading price of the ordinary shares over a period preceding the closing of the acquisition. InSeptember 2022 , we funded$300 million under the Development Funding Bonds. In the fourth quarter of 2022, we recognized impairment charges of$433.7 million related to otilimab and gantenerumab, two of the development stage products that we acquired royalties on from MorphoSys. •InApril 2021 , we acquired a royalty interest in Oxlumo from Dicerna Pharmaceuticals, Inc. for an upfront cash payment of$180 million and up to$60 million in contingent sales-based milestone payments. Oxlumo, which has been approved by the FDA and EMA for the treatment of primary hyperoxaluria type 1, is marketed by Alnylam. •InMarch 2021 , we acquired a royalty interest in the cabozantinib products Cabometyx and Cometriq from GSK for an upfront payment of$342 million and up to$50 million in additional payments contingent on the achievement of regulatory approvals of cabozantinib for prostate cancer and lung cancer inthe United States andEurope . 76 -------------------------------------------------------------------------------- •InJanuary 2021 , we acquired a royalty interest in seltorexant from Minerva Neurosciences, Inc. for an upfront payment of$60 million and up to$95 million in additional milestone payments, contingent on the achievement of certain clinical, regulatory and commercialization milestones. Seltorexant is currently in Phase 3 development for the treatment of major depressive disorder with insomnia symptoms by Johnson & Johnson. Additionally, inApril 2021 , we entered into an agreement with MSCI to develop thematic life sciences indexes. In return, we will receive a portion of MSCI's revenues from those indexes. The financial impact associated with this transaction was not material in 2022.
Liquidity and Capital Resources
Overview
Our primary source of liquidity is cash provided by operations. For 2022 and 2021, we generated$2.1 billion and$2.0 billion , respectively, in Net cash provided by operating activities. We believe that our existing capital resources, cash provided by operating activities and access to our undrawn Revolving Credit Facility (defined below) will continue to allow us to meet our operating and working capital requirements, to fund planned strategic acquisitions and R&D funding arrangements, and to meet our debt service obligations for the foreseeable future. We have historically operated at a low level of fixed operating costs. Our primary cash operating expenses, other than R&D funding commitments, include interest expense, our Operating and Personnel Payments, and legal and professional fees. We have access to substantial sources of funds in the capital markets and we may, from time to time, seek additional capital through a combination of additional debt or equity financings. InJuly 2021 , we issued$1.3 billion of senior unsecured notes. Additionally, we have a Revolving Credit Facility which provides for borrowing capacity of up to$1.5 billion that remains undrawn and available to us as ofDecember 31, 2022 . As ofDecember 31, 2022 and 2021, the par value of our total outstanding borrowings was$7.3 billion . A summary of our borrowing activities, balances and compliance with certain debt covenants under various financing arrangements is included in Note 11-Borrowings within the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. We have historically funded our acquisition program through free cash flow, equity contributions and debt. Our low operating costs coupled with a lack of capital expenditures and low taxes have contributed to our strong financial profile, resulting in high operating leverage and high conversion of our Adjusted Cash Receipts to Adjusted Cash Flow. We expect to continue funding our current and planned operating costs (excluding acquisitions) principally through our cash flow from operations and our acquisition program through cash flow and issuances of equity and debt. In the past, we have supplemented our available cash and cash equivalents on hand with attractive debt capital to fund certain strategic acquisitions. Our ability to satisfy our working capital needs, debt service and other obligations, and to comply with the financial covenants under our financing agreements depends on our future operating performance and cash flow, which are in turn subject to prevailing economic conditions and other factors, many of which are beyond our control.
Cash Flows
The following table and analysis of cash flow changes presents a summary of our cash flow activity for 2022 compared to 2021 (in thousands). For a discussion of cash flow activities for 2021 compared to 2020, please refer to Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 . Years Ended December 31, 2022 2021 Change Cash provided by (used in): Operating activities$ 2,143,980 $ 2,017,536 $ 126,444 Investing activities (1,029,421) (1,870,280) 840,859 Financing activities (944,856) 385,112 (1,329,968) 77
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Analysis of Cash Flow Changes
Operating Activities
Cash provided by operating activities increased by$126.4 million in 2022 compared to 2021, primarily driven by an increase in cash collections from financial royalty assets of$191.4 million . The increase in royalty receipts was partially offset by lower cash collections from intangible assets of$78.2 million , as our royalty receipts on Januvia, Janumet and other DPP-IVs substantially ended in the second quarter of 2022, and higher interest paid of$39.7 million , primarily due to the interest payments made on the 2021 Notes commencing in 2022. Investing Activities Cash used in investing activities decreased by$840.9 million in 2022 compared to 2021, primarily driven by a$449.9 million decrease in cash used for acquisitions of financial royalty assets and the$479.5 million receipt of accelerated redemption payments for all outstanding Series A and Series B Preferred Shares following Pfizer's acquisition of Biohaven inOctober 2022 . The lower use of cash was further driven by a$156.2 million increase in the overall net cash provided by marketable securities and higher proceeds from equity securities in 2022. The lower use of cash was partially offset by the funding of$300 million under the Development Funding Bonds with MorphoSys in 2022.
Financing Activities
Cash used in financing activities in 2022 was
Sources of Capital
As ofDecember 31, 2022 , our cash and cash equivalents and marketable securities totaled$1.7 billion and$24.4 million , respectively. As ofDecember 31, 2021 , our cash and cash equivalents and marketable securities totaled$1.5 billion and$581.9 million , respectively. We intend to fund short-term and long-term financial obligations as they mature through cash and cash equivalents, sales of marketable securities, future cash flows from operations or the issuance of additional debt. Our ability to generate cash flows from operations, issue debt or enter into financing arrangements on acceptable terms could be adversely affected if there is a material decline in the sales of the underlying pharmaceutical products in which we hold royalties, deterioration in our key financial ratios or credit ratings, or other material unfavorable changes in business conditions. Currently, we believe that we have sufficient financial flexibility to issue debt, enter into other financing arrangements and attract long-term capital on acceptable terms to support our growth objectives. 78 --------------------------------------------------------------------------------
Borrowings
Our borrowings as ofDecember 31, 2022 and 2021 consisted of the following (in thousands): As of December 31, As of December 31, Date of Issuance Maturity 2022 2021 Senior Unsecured Notes:$1,000,000 , 0.75% (issued at 99.322% of par) 9/2020 9/2023$ 1,000,000 $ 1,000,000 $1,000,000 , 1.20% (issued at 98.875% of par) 9/2020 9/2025 1,000,000 1,000,000$1,000,000 , 1.75% (issued at 98.284% of par) 9/2020 9/2027 1,000,000 1,000,000$1,000,000 , 2.20% (issued at 97.760% of par) 9/2020 9/2030 1,000,000 1,000,000$600,000 , 2.15% (issued at 98.263% of par) 7/2021 9/2031 600,000 600,000$1,000,000 , 3.30% (issued at 95.556% of par) 9/2020 9/2040 1,000,000 1,000,000$1,000,000 , 3.55% (issued at 95.306% of par) 9/2020 9/2050 1,000,000 1,000,000$700,000 , 3.35% (issued at 97.565% of par) 7/2021 9/2051 700,000 700,000 Total senior unsecured debt 7,300,000 7,300,000 Unamortized debt discount and issuance costs (183,678) (203,930) Total long-term debt, including current portion 7,116,322 7,096,070 Less: Current portion of long-term debt (997,512) - Total long-term debt$ 6,118,810 $ 7,096,070 Senior Unsecured Notes OnJuly 26, 2021 , we issued the 2021 Notes with a weighted average coupon rate of 2.80% and requiring annual interest payments of approximately$36.4 million , paid semi-annually. OnSeptember 2, 2020 , we issued$6.0 billion of senior unsecured notes (the "2020 Notes") with a weighted average coupon rate of 2.13% and requiring annual interest payments of approximately$127.5 million , paid semi-annually. We used the net proceeds from the 2020 Notes offering, together with available cash on hand, to repay in full the outstanding principal amounts of term loans under our prior senior secured credit facilities. We refer to the 2020 Notes and 2021 Notes, collectively, as the "Notes." Indentures governing the Notes contain certain covenants with which we were in compliance as ofDecember 31, 2022 .
Senior Unsecured Revolving Credit Facility
OnSeptember 15, 2021 , we entered into an amended and restated revolving credit agreement, which was further amended onOctober 31, 2022 (the "Credit Agreement"). The Credit Agreement amended and restated the prior credit agreement that our subsidiary,RP Holdings , as borrower, entered into onSeptember 18, 2020 , which provided for a five-year unsecured revolving credit facility (the "Revolving Credit Facility") with borrowing capacity of up to$1.5 billion for general corporate purposes. The Revolving Credit Facility has a maturity date ofOctober 31, 2027 . The Credit Agreement contains certain customary covenants, which we were in compliance with as ofDecember 31, 2022 . The Revolving Credit Facility remains undrawn and available to us as ofDecember 31, 2022 . Uses of Capital Acquisitions of Royalties
We acquire product royalties in ways that can be tailored to the needs of our partners through a variety of structures:
•Third-party Royalties - Existing royalties on approved or late-stage development therapies with high commercial potential. A royalty is the contractual right to a percentage of top-line sales from a licensee's use of a product, technology or intellectual property. The majority of our current portfolio consists of third-party royalties.
•Synthetic Royalties - Newly-created royalties on approved or late-stage
development therapies with strong proof of concept and high commercial
potential. A synthetic royalty is the contractual right to a percentage of
top-line sales by the developer or marketer of a therapy in exchange for
funding. A synthetic royalty may also include contingent milestone payments. We
also fund ongoing R&D for biopharmaceutical companies in exchange for future
royalties and milestones if the product or indication we are funding is
approved.
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•Launch and Development Capital - Tailored supplemental funding solutions,
generally included as a component within a transaction, increasing the scale of
our capital. Launch and development capital is generally provided in exchange
for a long-term stream of fixed payments with a predetermined schedule around
the launch of a drug. Launch and development capital may also include a direct
investment in the public equity of a company.
•M&A Related - We acquire royalties in connection with M&A transactions, often
from the buyers of biopharmaceutical companies when they dispose of the
non-strategic assets of the target company following the closing of the
acquisition. We also seek to partner with companies to acquire other
biopharmaceutical companies that own significant royalties. We may also seek to
acquire biopharmaceutical companies that have significant royalties or where we
can create royalties in subsequent transactions.
Additionally, we may identify additional opportunities, platforms or technologies that leverage our capabilities such as our strategic alliance with MSCI to develop thematic life sciences indexes.
Distributions to Shareholders
We paid dividends to holders of our Class A ordinary shares of$333.3 million and$285.2 million in 2022 and 2021, respectively. We do not have a legal obligation to pay a quarterly dividend or dividends at any specified rate or at all.
Other Funding Arrangements
InJanuary 2022 , we entered into a long-term funding agreement with Cytokinetics to provide up to$300 million of capital ("Cytokinetics Commercial Launch Funding") available in five tranches to support Cytokinetics for further development of aficamten and potential commercialization of omecamtiv mecarbil. We funded the initial tranche of$50 million of the Cytokinetics Commercial Launch Funding upon closing. During 2022, we amended the funding agreement to increase the required draw amount, extend the draw period and modify the return for the second and third tranches. Cytokinetics is required to draw$50 million if a certain contingency is met and has the option to draw the remaining$200 million upon the occurrence of certain regulatory and clinical development milestones. As ofDecember 31, 2022 , we expect$125 million of the optional$200 million to remain available under the Cytokinetics Commercial Launch Funding due to the likelihood that certain regulatory milestones will not be met byMarch 31, 2023 . We may have other funding arrangements where we are contractually obligated to fund R&D activities performed by our development partners. We also have funding arrangements related to our equity method investments in the Avillion Entities. As our committed capital requirements are based on phases of development, the completion of which is highly uncertain, only the capital required to fund the current stage of development under such funding arrangements is considered committed capital, which approximates$43.8 million as ofDecember 31, 2022 . We also have certain milestone payments that are contingent on the successful achievement of certain development, regulatory approval or commercial milestones. These contingent milestone payments are not considered contractual obligations. In 2022, we made a$50 million milestone payment to Cytokinetics which was triggered following Cytokinetics' announcement that it initiated the first pivotal clinical trial in oHCM. In 2021, we made a$100 million payment to Biohaven related to a development milestone that was achieved upon the start of the oral zavegepant Phase 3 program. 80 --------------------------------------------------------------------------------
Debt Service
As ofDecember 31, 2022 , the future principal and interest payments under our Notes over the next five years and thereafter are as follows (in thousands): Year Principal Payments Interest Payments 2023 $ 1,000,000 $ 163,850 2024 - 156,350 2025 1,000,000 156,350 2026 - 144,350 2027 1,000,000 144,350 Thereafter 4,300,000 1,925,900 Total (1) $ 7,300,000$ 2,691,150
(1)Excludes unamortized debt discount and issuance costs of
Operating and Personnel Payments
Under the Management Agreement, we pay quarterly Operating and Personnel Payments equal to 6.5% of the cash receipts from royalty investments for such quarter and 0.25% of our security investments under GAAP as of the end of each quarter. Because the Operating and Personnel Payments are determined based on cash receipts, the amounts are variable. The expenses incurred in respect of Operating and Personnel Payments are expected to comprise the most significant component of G&A expenses on an ongoing basis.
Guarantor Financial Information
Our obligations under the Notes are fully and unconditionally guaranteed byRP Holdings , a non-wholly owned subsidiary (the "Guarantor Subsidiary"). Our remaining subsidiaries (the "Non-Guarantor Subsidiaries") do not guarantee the Notes. Under the terms of the indenture governing the Notes,Royalty Pharma plc and the Guarantor Subsidiary each fully and unconditionally, jointly and severally, guarantee the payment of interest, principal and premium, if any, on the Notes. As ofDecember 31, 2022 , the par value and carrying value of the total outstanding and guaranteed Notes was$7.3 billion and$7.1 billion , respectively. The following financial information presents summarized combined balance sheet information as ofDecember 31, 2022 , and summarized combined statement of operations information for 2022 forRoyalty Pharma plc andRP Holdings . All intercompany balances and transactions betweenRoyalty Pharma plc andRP Holdings are eliminated in the presentation of the combined financial statements.RP Holdings' most significant asset is its investment in operating subsidiaries, which has been eliminated in the table below to exclude investments in Non-Guarantor Subsidiaries. Our operating subsidiaries hold the majority of our cash and cash equivalents, marketable securities and financial royalty assets. As a result, our ability to make required payments on the Notes depends on the performance of our operating subsidiaries and their ability to distribute funds to us. There are no material restrictions on distributions from the operating subsidiaries. Amounts presented below do not represent our total consolidated amounts as ofDecember 31, 2022 or for the year ended 2022 (in thousands):
Summarized Combined Balance Sheet
As of December 31, 2022
Current assets $ 92,805
Current interest receivable on intercompany notes due from Non-Guarantor Subsidiaries
14,744
Current intercompany notes receivable due from Non-Guarantor Subsidiaries
269,617
Non-current assets 4,033
Non-current intercompany notes receivable due from Non-Guarantor Subsidiaries
1,986,906
Current liabilities 1,053,942
Current interest payable on intercompany notes due to Non-Guarantor Subsidiaries
14,744
Current intercompany notes payable due to Non-Guarantor Subsidiaries
269,617
Non-current liabilities 6,118,022
Non-current intercompany notes payable due to Non-Guarantor
Subsidiaries 1,655,842
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Summarized Combined Statement of Operations
Year Ended December 31,
2022
Interest income on intercompany notes receivable from Non-Guarantor
Subsidiaries $ 65,738
Other income 1,492
Operating expenses 208,459
Interest expense on intercompany notes payable with Non-Guarantor
Subsidiaries 50,781
Net loss 192,010
Critical Accounting Policies and Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles inthe United States requires the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Certain of these policies are considered critical as they have the most significant impact on our financial condition and results of operations and require the most difficult, subjective, or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain. On an ongoing basis, we evaluate our estimates that are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. The result of these evaluations forms the basis for making judgments about the carrying values of assets and liabilities and the reported amount of income and expenses that are not readily apparent from other sources. Because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates, and such differences could be material. Our most critical accounting policies relate to our financial royalty assets and the full descriptions can be found in Note 2-Summary of Significant Accounting Policies to our consolidated financial statements. Similarly, the most significant judgments and estimates applied by management are associated with the measurement of our financial royalty assets at amortized cost using the prospective effective interest method. The application of the prospective approach to calculate interest income from our financial royalty assets requires management's judgment in forecasting the expected future cash flows of the underlying royalties. These estimates and judgments arise because of the inherent uncertainty in predicting future events. We evaluate financial royalty assets for impairment on an individual basis by comparing the effective interest rate at each reporting date to that of the prior period. If the effective interest rate for the current period is lower than the prior period, and if the gross cash flows have declined (expected and collected), management records a provision for the change in expected cash flows. The provision is measured as the difference between the financial royalty asset's amortized cost basis and the net present value of the expected future cash flows, calculated based on the prior period's effective interest rate. The amount recognized as provision expense increases the financial royalty asset's cumulative allowance, which reduces the net carrying value of the financial royalty asset.
Factors Impacting Expected Future Cash Flows
The amounts and timing of forecasted expected future cash flows are largely influenced by sell-side equity research analyst coverage, commercial performance of the product and the royalty duration.
•Analyst coverage. Forecasts of expected future cash flows are developed from
sales projections of the underlying biopharmaceutical products as published in
sell-side equity research analyst reports. In projecting future cash flows, our
policy is to rely on sell-side research analysts' consensus sales forecasts to
derive annual sales projections for each financial royalty asset over the
periods for which we are entitled to royalties or milestones. These forecasts
are based on market research that analyzes factors such as growth in global
economies, industry trends and product life cycles. For the majority of the
portfolio of financial royalty assets, management utilizes statistical curves to
project future sales for a portion of the royalty duration when sell-side equity
research coverage ends or when estimates are not available for the duration of
the royalty. The statistical curves are modelled from a combination of
historical trends and available sell-side equity research analyst consensus
sales estimates. In limited cases when the statistical curve is not used,
management may develop and apply growth rate estimates from existing sell-side
equity research analysts' consensus sales forecasts to project future sales for
products. Based on the level of detail in sell-side equity research analyst
models, management can also be required to apply assumptions to the sales
forecasts to estimate the quarterly and geographical allocation from annual
sales projections and, for franchised products, to estimate the product mix and
pricing mix, or to exclude from projections sales forecasts for unapproved
products or indications. Our contractual royalty terms, rates, and any
milestones are then applied to the adjusted sales projections to calculate the
expected royalty or milestone payments over the term of the financial royalty
asset's life, forming the basis for our forecast of expected future cash flows
used to calculate and measure interest income.
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•Commercial performance. The approval of a product for use in new indications
can extend the date through which we are entitled to royalties or milestones on
that product. For certain financial royalty assets, such as the cystic fibrosis
franchise, we are entitled to royalties on approved combination products and may
be entitled to royalties on future combination products, which, once approved,
create new cash flow streams which were not initially contemplated and for which
sales were previously not reflected in expected future cash flows. We generally
do not recognize income from, or forecast sales for, unapproved products or
indications. If a product is removed from all or a portion of a market,
subsequent sell-side equity research analysts' consensus sales forecasts will
reflect the expected drop in sales. Both the new cash flow streams and the
cessation of cash flow streams related to a product's performance in the market
over the royalty term can materially affect our forecast of expected future cash
flows.
•Royalty duration. The duration of a royalty can be based on a variety of
factors, such as regulatory and marketing approval dates, patent expiration
dates, the number of years from first commercial sale, the first date of
manufacture of the patent-protected product, the entry of generics or a
contractual date arising from litigation, which are all impacted by the point in
time in the product's life cycle at which we acquire the royalty. Royalty
duration varies by geography as the United States , European Union and other
jurisdictions may be subject to different country-specific patent protection
terms or exclusivity based on contractual terms. Products may be covered by a
number of patents and, for products whose royalty term is linked to the
existence of valid patents, management is required to make judgments about the
patent providing the strongest patent protection to align the period over which
management forecasts expected future cash flows to the royalty term. It is
common for the latest expiring patent in effect at the date we acquire a
financial royalty asset to be extended, adjusted or replaced with newer dated
patents subsequent to our acquisition of a royalty due to new information,
resulting in changes to the royalty duration in later periods. Patents may
expire earlier than expected at the time of the acquisition due to the loss of
patent protection, loss of data exclusivity on intellectual property,
contractual licensing terms limiting royalty payments based on time from product
launch, due to recent legal developments or litigation. Macroeconomic factors,
such as changes in economies or the competitive landscape, including the
unexpected loss of exclusivity to the products underlying our portfolio of
royalties, changes in government legislation, product life cycles, industry
consolidations and other changes beyond our control could result in a positive
or negative impact on our forecast of expected future cash flows.
Significant Assumptions Applied in Developing Forecasted Expected Future Cash Flows
As part of the preparation of the forecasted expected future cash flows, which
relies on the sources and variables discussed above, management is required to
make assumptions around the following forecast inputs: (1) estimates of the
duration of the royalty, which includes consideration of the strength of patent
protection and anticipated entry of generics, (2) product growth rates and sales
trends in outer years, generally projected through statistical curves, (3) the
product and pricing mix for franchised products, and (4) the geographical
allocation of annual sales data from sell-side equity research analysts' models.
The most significant assumptions used in forecasting the expected future cash
flows for our royalties and requiring management's judgement include (1)
estimates of the duration of the royalty and (2) sales trends and product growth
rates in outer years of the royalty term, which are primarily derived from
statistical models.
The royalty duration is important for purposes of accurately measuring interest
income over the life of a financial royalty asset. In making assumptions around
the royalty duration for terms that are not contractually fixed, management
considers the strength of existing patent protection, timing for expected entry
of generics, geographical exclusivity periods and potential patent term
extensions tied to the underlying product. It is common for royalty durations to
expire earlier or later than anticipated due to unforeseen developments over
time, including with respect to the granting of patents and patent term
extensions, the invalidation of patents, litigation between the party
controlling the patents and third party challengers of the patents, the ability
of third parties to design around or circumvent valid patents, the granting of
regulatory exclusivity periods or extensions, timing for the arrival of generic
or biosimilar competitor products, changes to legal or regulatory regimes
affecting intellectual property rights or the regulation of pharmaceutical
products, product life cycles, and industry consolidations.
When royalty-bearing pharmaceutical products have limited or no coverage by
sell-side equity research analysts, or where sell-side equity research analyst
estimates are not available for the full term of our royalty, particularly for
the later years in a product's life, we generally incorporate a statistical
curve developed using historical sales data and available consensus sales
projections to forecast product sales over the remaining life of the product.
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Even though we believe interest income from financial royalty assets and the
associated non-cash provision for changes in future cash flows are not
indicative of our near-term financial performance and should not be used as a
source for predicting future income or growth trends, changes in the
aforementioned assumptions could result in a material impact to our financial
statements. A shortened royalty term can result in a reduction in interest
income, significant reductions in total royalty payments over time compared to
expectations or a permanent impairment. If the effective interest rate is lower
for the current period than the prior period, and if the gross cash flows have
declined (expected and collected) this would result in the immediate recognition
of non-cash provision expense even though the applicable cash inflows will not
be realized for many years into the future. Small declines in sell-side equity
research analysts' consensus sales forecasts over a long time horizon can result
in an immediate non-cash income statement expense recognition, even though the
applicable cash inflows will not be realized for many years into the future.
Below is a summary of the sensitivity of our current year results in relation to
the royalty duration for our top three financial royalty assets based on net
carrying value as of December 31, 2022 . Because these are long-dated financial
royalty assets, we have assumed a change of two years in the estimated duration
to sensitize the financial statement impact. The effect of a change in estimated
duration is the factor that would have the most significant impact on our
consolidated statement of operations. There have not been any significant
changes to the estimated duration of expected future cash flows for our top
three financial royalty assets during 2022, 2021 and 2020.
If the duration of these financial royalty assets were extended two years by
assuming the statistically projected growth trends continue and all other
royalty terms and assumptions remain unchanged, any impact to interest income
would be recognized prospectively over the remaining expected life of the
financial asset. Therefore, the impact to interest income is not disclosed
below. However, an extended duration for a financial royalty asset could result
in the reduction of any existing cumulative allowance for changes in expected
future cash flows, which would be recognized in the current period as provision
income and is reflected in the table below for these top three financial royalty
assets. If the duration for these financial royalty assets were reduced by two
years by eliminating the corresponding forecasted expected future cash flows in
that two year period while keeping all other royalty terms and assumptions
unchanged, we would recognize immediate incremental provision expense in the
current period as a result of applying the prospective method of the effective
interest rate methodology. The extension and reduction in royalty terms are
modelled in isolation for purposes of the sensitivity disclosures below and does
not include any consideration of the related allowance for current expected
credit losses. The measurement of interest income from our financial royalty
assets is recalculated each reporting period, which requires updates to various
inputs and assumptions, including estimated royalty duration. Therefore, any
actual impact to recognition of provision income or expense would be different
than the sensitivity disclosure below. The impact of these sensitivity
assumptions is summarized as follows (in thousands):
Year Ended Year Ended
December 31, December 31,
2022 2022
Provision Provision
Income for Expense for
Changes in Changes in
Estimated Royalty Change in Duration Expected Cash Change in Duration Expected Cash
Duration (1) Assumption Applied Flows Assumption Applied Flows
Cystic fibrosis
franchise 2037 (2) + 2 years $ (10,908) - 2 years $ 276,338
Tysabri (3) + 2 years $ (77,443) - 2 years $ 119,168
Trelegy 2029-2030 + 2 years $ (24,126) - 2 years $ 249,612
(1)Durations shown represent our estimates as of the current reporting date of
when a royalty will substantially end, which may depend on clinical trial
results, regulatory approvals, contractual terms, commercial developments,
estimates of patent expiration dates (which may include estimated patent term
extensions) or other factors and may vary by geography. There can be no
assurances that our royalties will expire when expected.
(2)Royalty is perpetual; year shown represents Trikafta expected patent
expiration and potential sales decline based on timing of potential generic
entry.
(3)RPIFT acquired a perpetual royalty on net sales of Tysabri. We have applied
an end date of 2031 for purposes of accreting income over the royalty term,
which is periodically reviewed.
Recent Accounting Pronouncements
See Note 2-Summary of Significant Accounting Policies to our consolidated financial statements for additional information on recently issued accounting standards.
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