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|Item 7.01|| |
Regulation FD Disclosure.
On March 15, 2023, Royalty Pharma plc (the “Company”) announced that it has received a $475 million accelerated milestone payment from Pfizer, following the U.S. Food and Drug Administration approval of Zavzpret (zavegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. As a result, the Company raised its full year 2023 Adjusted Cash Receipts (non-GAAP) guidance to between $2,850 million and $2,950 million (from between $2,375 million and $2,475 million), excluding transactions announced subsequent to the date of this announcement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.
|Item 9.01|| |
Financial Statements and Exhibits
|99.1||Press release issued by Royalty Pharma plc, dated March 15, 2023|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirement of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|ROYALTY PHARMA PLC|
|Date: March 15, 2023||By:|| |
/s/ Terrance Coyne
|Chief Financial Officer|
ROYALTY PHARMA RAISES FULL YEAR 2023 GUIDANCE
Royalty Pharma now expects 2023 Adjusted Cash Receipts(1) (non-GAAP) to be between $2,850 million and $2,950 million, excluding contributions from future transactions.
NEW YORK, NY, March 15, 2023 Royalty Pharma plc (Nasdaq: RPRX) today announced that it has received a $475 million accelerated milestone payment from Pfizer, following the U.S. Food and Drug Administration (FDA) approval of Zavzpret (zavegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. As a result, Royalty Pharma is raising its full year 2023 Adjusted Cash Receipts (non-GAAP) guidance to between $2,850 million and $2,950 million (from between $2,375 million and $2,475 million), excluding transactions announced subsequent to the date of this release.
We are pleased that Zavzpret was approved by the U.S. FDA, which provides another important new treatment option for migraine patients, said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. Furthermore, this accelerated return on our Zavzpret R&D funding provides additional capital that can be redeployed to create long-term shareholder value.
Royalty Pharma will now receive royalties on net sales of both Nurtec ODT and Zavzpret.
Royalty Pharma today provides this guidance based on its most up-to-date view on its prospects. This guidance assumes no major unforeseen adverse events and excludes the contributions from transactions announced subsequent to the date of this press release. Furthermore, Royalty Pharma may amend its guidance in the event it engages in new royalty transactions which have a material near-term financial impact on the company.
Royalty Pharma has not reconciled its non-GAAP 2023 guidance to the most directly comparable GAAP measure, net cash provided by operating activities, at this time due to the inherent difficulty in accurately forecasting and quantifying certain amounts that are necessary for such reconciliation, including, primarily, payments for operating and professional costs, distributions from equity method investees and interest received. Royalty Pharma is not able to forecast on a GAAP basis with reasonable certainty all adjustments needed in order to project net cash provided by operating activities at this time.
About Royalty Pharma
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industrys leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly - directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharmas current portfolio includes royalties on more than 35 commercial products, including Vertexs Trikafta, Kalydeco, Orkambi and Symdeko, Biogens Tysabri, AbbVie and Johnson & Johnsons Imbruvica, Astellas and Pfizers Xtandi, GSKs Trelegy, Novartis Promacta, Pfizers Nurtec ODT, Johnson & Johnsons Tremfya, Roches Evrysdi, Gileads Trodelvy, and 11 development-stage product candidates.
The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute forward-looking statements as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the companys opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharmas strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as may, might, will, should, expects, plans, anticipates, believes, estimates, target, forecast, guidance, goal, predicts, project, potential or continue, the negative of these terms or similar expressions. Forward-looking statements are based on managements current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharmas performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of Royalty Pharmas control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. Royalty Pharma does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. Certain information contained in this document relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Royalty Pharmas own internal estimates and research. While Royalty Pharma believes these third-party sources to be reliable as of the date of this document, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this document involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the company believes its own internal research is reliable, such research has not been verified by any independent source. For further information, please reference Royalty Pharmas reports and documents filed with the U.S. Securities and Exchange Commission (SEC) by visiting EDGAR on the SECs website at www.sec.gov.
(1) 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, and 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 Royalty Pharma Select Finance Trust (RPSFT). See Royalty Pharmas Annual Report on Form 10-K filed with the SEC on February 15, 2023 for additional discussion.
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