Halozyme Therapeutics, Inc. Provides Earnings Guidance for the Fiscal 2019; Provides 2019 Pipeline Update
January 10, 2019 at 12:00 am IST
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Halozyme Therapeutics, Inc. provided earnings guidance for the fiscal 2019. In fiscal 2019, the company expects net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
The company announced that by the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021. The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company's phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019. Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.
Halozyme Therapeutics, Inc. is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. The Companyâs ENHANZE drug delivery technology with the proprietary enzyme rHuPH20, its commercially validated solution is used to facilitate the subcutaneous (SC) delivery of injected drugs and fluids, with a focus on reducing treatment burden for patients. It also develops, manufactures, and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies. The Company has two commercial proprietary products, Hylenex and XYOSTED, partnered commercial products and ongoing product development programs with several pharmaceutical companies. It markets and sells Hylenex recombinant, which is a formulation of rHuPH20. It markets and sells its proprietary product XYOSTED for SC administration of testosterone replacement therapy (TRT) in adult males.