Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, provided a pipeline update and announced its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference. “Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts,” said Dr. Helen Torley, president and chief executive officer. “In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019.”
Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately USD 1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.
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 USD 1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be USD 1 billion, with USD 225 million to USD 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.
2019 financial guidance
The company also provided financial guidance for 2019:
- Net revenue of USD 175 million to USD 185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
- Operating expenses of USD 265 million to USD 275 million, or USD 225 million to USD 235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
- Operating cash burn of USD 75 million to USD 85 million.
- Debt repayment of approximately USD 90 million.
- Year-end cash balance of USD 180 million to USD 190 million.
The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019. A replay of Dr. Torley’s presentation at the conference can be accessed for the next 90 days via the Investors section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the Investors section of www.halozyme.com. – Medical Buyer Bureau