Business
Halozyme Reports First Quarter 2020 Results
- DARZALEX FASPRO™ Utilizing ENHANZE® Technology Receives U.S. FDA Approval with Subcutaneous Administration Time of 3 - 5 Minutes and Lower Rate of
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- DARZALEX FASPRO™ Utilizing ENHANZE® Technology Receives U.S. FDA Approval with Subcutaneous Administration Time of 3 - 5 Minutes and Lower Rate of Administration-related Reactions When Compared with IV DARZALEX® -\n - Positive CHMP Opinion Recommending Approval of DARZALEX® SC Formulation in Multiple Current IV DARZALEX® Indications -\n - BLA Accepted for Subcutaneous Fixed-Dose Combination of Perjeta® and Herceptin® Utilizing ENHANZE® with FDA Action Date of October 18, 2020 -\n - 2020 Guidance of $230 to $245 Million in Revenues and $0.60 to $0.75 Earnings Per Share with Profitability Beginning Second Quarter Remains Unchanged -\n\n\nSAN DIEGO, May 11, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the first quarter ended March 31, 2020 and provided an update on its recent corporate activities and outlook.\n\"This has been a very exciting start to the year for Halozyme as we have achieved multiple value-creating events in our ENHANZE® business, including U.S. FDA approval for DARZALEX FASPROTM with a broad set of label indications, and the receipt of a positive CHMP opinion in the EU, also recommending a broad set of label indications. The positive CHMP opinion is typically a precursor to marketing clearance,\" said Dr. Helen Torley, president and chief executive officer. \"As we look ahead, we are excited about the launches of subcutaneous DARZALEX® in the U.S. and E.U. as well as the potential FDA approval of the subcutaneous fixed-dose combination of Perjeta® and Herceptin® later this year, and what they may mean for patients.\"\n\"I want to express my gratitude to the Halozyme team, our partners and suppliers for our continued progress in spite of the challenges posed by COVID-19,\" continued Dr. Torley. \"In light of these challenges, it is obviously difficult to predict how the pandemic recovery will unfold in the coming quarters. However, based on the latest information from our partners and suppliers, and our team's commitment to maintaining a lean operating structure, we feel confident maintaining our 2020 financial guidance at this time.\"\nFirst Quarter 2020 and Recent Highlights Include:\nOn May 1, the Company announced that The Janssen Pharmaceutical Companies of Johnson and Johnson received U.S. FDA approval of DARZALEX FASPROTM in four regimens across five ...