HALOZYME PROVIDES UPDATE ON LICENSEE CO-FORMULATION PATENT HEARING IN EUROPE
Halozyme Therapeutics (NASDAQ: HALO) announced that the European Patent Office (EPO) revoked one of Janssen's co-formulation patents for DARZALEX® SC. The company affirms this decision will not impact its 2024 royalty revenue guidance of $520-555 million or its projection to exceed $1 billion in royalty revenues by 2027. The company maintains that U.S. and European royalty revenues from DARZALEX FASPRO® and SC will remain unaffected through 2032. The decision does not affect Halozyme's composition of matter patents for ENHANZE® or other licensees' ability to obtain co-formulation patents.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che l'Ufficio Europeo dei Brevetti (EPO) ha revocato uno dei brevetti di co-formulazione di Janssen per DARZALEX® SC. L'azienda afferma che questa decisione non influenzerà il suo guidance sui ricavi da royalties per il 2024 di 520-555 milioni di dollari né la sua proiezione di superare 1 miliardo di dollari in ricavi da royalties entro il 2027. L'azienda sostiene che i ricavi da royalties negli Stati Uniti e in Europa derivanti da DARZALEX FASPRO® e SC rimarranno inalterati fino al 2032. La decisione non influisce sui brevetti di composizione di materia di Halozyme per ENHANZE® né sulla capacità di altri licenziatari di ottenere brevetti di co-formulazione.
Halozyme Therapeutics (NASDAQ: HALO) anunció que la Oficina Europea de Patentes (EPO) revocó una de las patentes de coformulación de Janssen para DARZALEX® SC. La compañía afirma que esta decisión no afectará su pronóstico de ingresos por regalías de 520-555 millones de dólares para 2024 ni su proyección de superar 1 mil millones de dólares en ingresos por regalías para 2027. La empresa mantiene que los ingresos por regalías en EE. UU. y Europa de DARZALEX FASPRO® y SC permanecerán sin cambios hasta 2032. La decisión no afecta las patentes de composición de materia de Halozyme para ENHANZE® ni la capacidad de otros licenciatarios para obtener patentes de coformulación.
Halozyme Therapeutics (NASDAQ: HALO)는 유럽 특허청(EPO)이 Janssen의 DARZALEX® SC에 대한 공동 제형 특허 중 하나를 취소했다고 발표했습니다. 회사는 이 결정이 2024년 로열티 수익 가이던스인 5억 2천만 달러에서 5억 5천 5백만 달러에 영향을 미치지 않으며, 2027년까지 로열티 수익이 10억 달러를 초과할 것이라는 전망에도 영향을 주지 않을 것이라고 주장하고 있습니다. 회사는 DARZALEX FASPRO®와 SC에서 발생하는 미국 및 유럽의 로열티 수익이 2032년까지 영향을 받지 않을 것이라고 강조합니다. 이 결정은 ENHANZE®에 대한 Halozyme의 물질 조성 특허나 다른 라이선스 사용자의 공동 제형 특허 획득 능력에 영향을 주지 않습니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé que l'Office Européen des Brevets (EPO) a révoqué l'un des brevets de co-formulation de Janssen pour DARZALEX® SC. L'entreprise affirme que cette décision n'aura pas d'impact sur ses prévisions de revenus de redevances de 520 à 555 millions de dollars pour 2024 ni sur sa projection de dépasser 1 milliard de dollars de revenus de redevances d'ici 2027. La société maintient que les revenus de redevances aux États-Unis et en Europe pour DARZALEX FASPRO® et SC resteront inchangés jusqu'en 2032. Cette décision n'affecte pas les brevets de composition de matière de Halozyme pour ENHANZE® ni la capacité des autres licenciés à obtenir des brevets de co-formulation.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass das Europäische Patentamt (EPO) eines von Janssens Co-Formulierungspatenten für DARZALEX® SC widerrufen hat. Das Unternehmen bestätigt, dass diese Entscheidung keinen Einfluss auf seine Umsatzprognose für Lizenzgebühren von 520-555 Millionen Dollar im Jahr 2024 haben wird und dass es erwartet, bis 2027 die Marke von 1 Milliarde Dollar an Lizenzgebühren zu überschreiten. Das Unternehmen betont, dass die Lizenzgebühren aus DARZALEX FASPRO® und SC in den USA und Europa bis 2032 unbeeinflusst bleiben werden. Die Entscheidung hat keinen Einfluss auf die Substanzpatente von Halozyme für ENHANZE® oder die Fähigkeit anderer Lizenznehmer, Co-Formulierungspatente zu erhalten.
- 2024 royalty revenue guidance maintained at $520-555 million
- Projected to exceed $1 billion in royalty revenues by 2027
- No impact on U.S. or European royalty revenues through 2032
- Company has 8 approved partner products, expected to reach 10 by 2025
- ENHANZE® composition patents remain unaffected
- EPO revocation of Janssen's co-formulation patent for DARZALEX® SC
Insights
The EPO's decision to revoke Janssen's co-formulation patent for DARZALEX SC appears largely inconsequential to Halozyme's business model and revenue projections. The key points supporting this assessment include:
- The company's core ENHANZE composition of matter patents remain unaffected in both the U.S. and Europe
- The decision is to a single co-formulation patent in Europe
- Janssen can appeal, which would suspend the revocation
- Other licensees' ability to obtain co-formulation patents remains intact
The company's confident stance is backed by solid projections, including
Company Projects No Impact on
Reiterates 2024 Royalty Revenue Guidance of
Conference Call Scheduled Today, Thursday, October 24 at 5:30am PT/8:30am ET
"We remain confident in our strong royalty revenue projections with 8 approved partner products on the market today, which is expected to reach 10 by 2025. The EPO decision on a single co-formulation patent in
"While we are disappointed with the EPO's decision today, if Janssen files an appeal in the case, today's decision would be suspended and the patent would remain in force until the case is finally decided," Dr. Torley concluded.
Today's decision by the EPO has no impact on Halozyme's composition of matter patents in the
Halozyme will provide additional details on today's EPO decision and its intellectual property portfolio during an Investor Update conference call today, Thursday, October 24 at 5:30am PT/8:30am ET. A webcast of the live call and presentation will be available through the "Investors" section of Halozyme's corporate website at ir.halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's royalty revenue projections for 2024, 2027 and through 2032). Forward-looking statements regarding the Company's business may include statements about the expected number of future approved partnered products, potential growth and receipt of royalty payments driven by our partners' development and commercialization efforts and the potential impact of the decision on a co-formulation patent referenced in this press release on the Company's 2024 royalty revenue guidance and future royalty revenues through 2032, and the ability of our licensees to obtain co-formulation patents and on certain composition of matter patents and the impact of appealing the decision. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected impact of the co-formulation patent decision referenced in this press release including unexpected results or delays in our licensees' ability to obtain co-formulation patents or in appealing the decision, unexpected impacts on our composition of matter patents, unexpected results regarding the growth of the Company's business or number of future approved partnered products, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-provides-update-on-licensee-co-formulation-patent-hearing-in-europe-302285843.html
SOURCE Halozyme Therapeutics, Inc.
FAQ
What happened to Halozyme's (HALO) patent in Europe on October 24, 2024?
Will the EPO patent decision affect Halozyme's (HALO) 2024 revenue guidance?
How many approved partner products does Halozyme (HALO) currently have?
What is Halozyme's (HALO) projected royalty revenue for 2027?
