Royalty Pharma to Acquire Royalty Interest in Geron’s RYTELO for $125 Million
Royalty Pharma (RPRX) has announced the acquisition of a synthetic royalty on U.S. sales of RYTELO from Geron for $125 million in cash upfront. RYTELO, FDA-approved in June 2024 for treating low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia, will generate tiered royalty payments ranging from 7.75% on annual net sales up to $500 million, 3.0% on sales between $500 million-$1 billion, and 1.0% on sales over $1 billion. The agreement includes provisions for royalty payment cessation based on multiple thresholds of the initial investment.
Royalty Pharma (RPRX) ha annunciato l'acquisizione di una royalty sintetica sulle vendite negli Stati Uniti di RYTELO da Geron per un importo di 125 milioni di dollari in contante anticipato. RYTELO, approvato dalla FDA nel giugno 2024 per il trattamento dei sindromi mielodisplastiche a rischio basso e intermedio-1 con anemia da trasfusione, genererà pagamenti royalty a livelli che varieranno dal 7,75% sulle vendite nette annuali fino a 500 milioni di dollari, 3,0% sulle vendite tra 500 milioni e 1 miliardo di dollari, e 1,0% sulle vendite superiori a 1 miliardo di dollari. L'accordo include disposizioni per l'interruzione dei pagamenti delle royalty sulla base di più soglie rispetto all'investimento iniziale.
Royalty Pharma (RPRX) ha anunciado la adquisición de una regalía sintética sobre las ventas en EE.UU. de RYTELO de Geron por un importe de 125 millones de dólares en efectivo por adelantado. RYTELO, aprobado por la FDA en junio de 2024 para el tratamiento de síndromes mielodisplásicos de riesgo bajo a intermedio-1 con anemia dependiente de transfusiones, generará pagos de regalías por niveles que varían desde el 7.75% sobre las ventas netas anuales hasta 500 millones de dólares, 3.0% sobre las ventas entre 500 millones y 1 mil millones de dólares, y 1.0% sobre las ventas superiores a 1 mil millones de dólares. El acuerdo incluye disposiciones para la cesación de los pagos de regalías basadas en múltiples umbrales de la inversión inicial.
로열티 제약 (RPRX)은 Geron으로부터 RYTELO의 미국 판매에 대한 합성 로열티를 현금으로 1억 2500만 달러에 인수했다고 발표했습니다. RYTELO는 2024년 6월 FDA 승인을 받았으며, 수혈 의존성 빈혈을 동반한 저위험에서 중간 1 위험의 골수형성이상 증후군을 치료하는 데 사용됩니다. 이 제품은 연간 순 판매가 5억 달러까지는 7.75%, 5억에서 10억 달러 사이에서는 3.0%, 10억 달러를 초과하는 판매에 대해서는 1.0%의 단계별 로열티 지급을 생성합니다. 이 계약에는 초기 투자에 대한 여러 기준에 따라 로열티 지급 중단에 대한 조항이 포함되어 있습니다.
Royalty Pharma (RPRX) a annoncé l'acquisition d'une redevance synthétique sur les ventes américaines de RYTELO auprès de Geron pour un montant de 125 millions de dollars en espèces dès le départ. RYTELO, approuvé par la FDA en juin 2024 pour le traitement des syndromes myélodysplasiques à risque faible à intermédiaire-1 avec anémie dépendante des transfusions, générera des paiements de redevances par paliers, allant de 7,75 % sur les ventes nettes annuelles jusqu'à 500 millions de dollars, 3,0 % sur les ventes entre 500 millions et 1 milliard de dollars, et 1,0 % sur les ventes de plus d'1 milliard de dollars. L'accord comprend des dispositions sur l'arrêt des paiements de redevances en fonction de plusieurs seuils de l'investissement initial.
Royalty Pharma (RPRX) hat den Erwerb einer synthetischen Lizenzgebühr auf den Verkauf von RYTELO in den USA von Geron für 125 Millionen Dollar im Voraus in bar angekündigt. RYTELO, das im Juni 2024 von der FDA zur Behandlung von myelodysplastischen Syndromen mit Risiko niedrig bis intermediär-1 mit transfusionsabhängiger Anämie zugelassen wurde, wird gestaffelte Lizenzgebührenzahlungen generieren, die von 7,75 % auf den jährlichen Nettoumsatz bis zu 500 Millionen Dollar, 3,0 % auf Umsätze zwischen 500 Millionen und 1 Milliarde Dollar und 1,0 % auf Umsätze über 1 Milliarde Dollar reichen. Die Vereinbarung enthält Bestimmungen zur Einstellung der Lizenzgebührenzahlungen basierend auf mehreren Schwellenwerten der ursprünglichen Investition.
- Immediate $125 million cash investment expanding synthetic royalty portfolio
- Tiered royalty structure provides potential for significant returns on investment
- Investment increases synthetic royalty funding to $925 million in 2024
- Partnership with FDA-approved therapy in an underserved market
- Royalty payments are capped at 1.65-2.0x of investment amount
- royalty duration through June 2031
Insights
This
The capped return structure (1.65x-2.0x multiple) provides clear upside potential for Royalty Pharma while offering Geron flexibility in their commercialization timeline. This deal structure suggests confidence in RYTELO's market potential, particularly given the NCCN Category 1 designation and ongoing Phase 3 trials that could expand its addressable market.
RYTELO's approval for lower-risk MDS with transfusion-dependent anemia addresses a significant unmet medical need. The NCCN Guidelines' Category 1 designation represents the highest level of evidence and uniform consensus, indicating strong clinical validation. The ongoing Phase 3 trial in myelofibrosis patients resistant to JAK inhibitors could substantially expand the drug's market opportunity.
The commercial potential appears promising given the treatment options in this space and the drug's potential expansion into additional hematologic malignancies. The structured deal terms suggest both parties anticipate meaningful market penetration, particularly considering the high unmet need in transfusion-dependent MDS patients.
- RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia
- Transaction increases Royalty Pharma’s synthetic royalty funding to
$925 million in 2024, highlighting the significant opportunity for this attractive funding modality
NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will acquire a synthetic royalty on U.S. sales of Geron Corporation’s (Nasdaq: GERN) RYTELO for
RYTELO was approved by the U.S. Food and Drug Administration in June 2024 for the treatment of certain adult patients with low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent (TD) anemia. Additionally, The National Comprehensive Cancer Network (NCCN) Guidelines were updated to include imetelstat as a Category 1 and 2A treatment of symptomatic anemia in patients with LR-MDS. Geron is currently enrolling a Phase 3 trial of imetelstat in myelofibrosis patients who are relapsed/refractory to JAK-inhibitors.
“RYTELO is an important therapy for the lower-risk MDS patient population, who otherwise have limited treatment options, and we look forward to its development in other hematologic malignancy indications. We are delighted to establish this partnership with Geron to help fuel their execution of significant commercial and development opportunities ahead” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma.
“The significant financial commitment from an exceptional long-term partner like Royalty Pharma strengthens our cash position and further solidifies our balance sheet, while providing flexibility to invest in our future” said John Scarlett, Geron’s President and Chief Executive Officer. “We believe that the terms reflect the significant commercial potential of RYTELO.”
Royalty Pharma has provided
Advisors
TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Geron. Goodwin Procter and Fenwick & West LLP served as legal advisors to Royalty Pharma.
About Royalty Pharma plc
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 industry’s 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 Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Novartis’ Promacta, Pfizer’s Nurtec ODT and Gilead’s Trodelvy, and 15 development-stage product candidates.
Royalty Pharma Forward-Looking Statements
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 company’s 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 Pharma’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s 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 the company’s 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. The company 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 the company’s own internal estimates and research. While the company 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 Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission ("SEC") by visiting EDGAR on the SEC's website at www.sec.gov.
Royalty Pharma Investor Relations and Communications
+1 (212) 883-6772
ir@royaltypharma.com
FAQ
What is the value of Royalty Pharma's (RPRX) acquisition of RYTELO royalty rights?
What are the royalty rates RPRX will receive from RYTELO sales?
When was RYTELO approved by the FDA?
What is the maximum return multiple for RPRX's RYTELO investment?
