Halozyme Therapeutics (HALO) Sees FY17 Rev. of $115M-$130M

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today provided program updates and its annual financial guidance at the 35th annual JP Morgan Healthcare Conference.

"We enter the year with strongly supportive data from our HALO 202 study in metastatic pancreatic cancer patients and momentum in our HALO 301 global registration trial for our investigational new drug PEGPH20 in a similar, targeted HA-High patient population," said Dr. Helen Torley, president and chief executive officer. "In 2017 we expect to make continued progress demonstrating the pan-tumor potential of PEGPH20, as we also focus on near-term catalysts in our revenue-generating ENHANZE™ platform, including the potential approval of rituximab SC in the U.S. and progressing other partnered programs in the clinic."

In addition to HALO 301, the company has ongoing studies of PEGPH20 in combination with Merck's KEYTRUDA® (pembrolizumab) in gastric and non-small-cell lung cancer patients and in collaboration with Eisai in combination with HALAVEN® (eribulin) in breast cancer patients. Two new studies exploring four tumor types are planned to start in 2017 as part of a recently announced clinical collaboration with Genentech. Under the collaboration, Genentech will evaluate PEGPH20 in combination with its anti-PDL1 TECENTRIQ® (atezolizumab) in pancreas and gastric cancer and Halozyme will evaluate the same combination in gallbladder cancer and cholangiocarcinoma. Halozyme has also been included in an innovative, patient-centered clinical trial planned for initiation in 2017 called Precision Promise, led by the Pancreatic Cancer Action Network.

In the Halozyme ENHANZE™ platform business, the company announced in November 2016 that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications with an action date in June. This is a co-formulation with Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera® SC brand in countries outside the U.S.

In addition, Halozyme plans in 2017 to support ongoing development of subcutaneous formulations for Roche's PERJETA® and Janssen's DARZALEX®, work with existing ENHANZE platform partners to advance development of additional licensed targets, and seek to sign new global licensing and collaboration agreements.

The company also provided financial guidance for 2017 of:

• Revenue of $115 million to $130 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements that may be signed during the year. The company expects to report $20 million in 2016 revenue for reimbursed partner R&D expenses that will not recur in 2017;
• Operating Expenses of $240 million to $250 million, supporting the ongoing Phase 3 study in metastatic pancreatic cancer patients and the continued execution of clinical programs to study the pan-tumor potential of PEGPH20;
• Year-end cash balance of $100 million to $110 million.

(Street sees FY revenue of $173 million, estimates may not compare.)

Dr. Torley will present at 3 p.m. PST, Jan. 9 at the conference. Her presentation will be webcast through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on approximately fifteen minutes prior to the presentation to register and download any necessary audio software.

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