On May 10, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results and recent highlights for the first quarter ended March 31 (Press release, Halozyme, MAY 10, 2018, View Source [SID1234526482]).
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"Reflecting the enthusiasm and opportunity for competitive differentiation that ENHANZE may provide, in the first quarter we supported our partners in planning for initiation of an unprecedented number of clinical study starts in 2018, including two additional Phase 1 studies that were not included in our forecast at the beginning of the year," said Dr. Helen Torley, president and chief executive officer. "The momentum we have with ENHANZE reinforces our conviction for the approximately $1 billion royalty revenue potential we outlined in January.
"For PEGPH20, we currently project we will achieve the target number of Progression-Free Survival (PFS) events in HALO-301 between December 2018 and February 2019. Upon achieving the target number of PFS events, final data collection and the steps required for database lock prior to the interim analysis will be initiated. With enrollment at the end of April on track with more than 350 patients, we continue to project approximately 500 patients will have been enrolled by year-end."
First Quarter 2018 and Recent Highlights include:
Two new ENHANZE Phase 1 clinical studies now planned for initiation in 2018 by collaboration partners, a result of momentum generated through new agreements in 2017. The eight ENHANZE-partnered products expected to be in a clinical study in 2018 is an increase from the company’s forecast in January of six.
Collaboration partner Bristol-Myers Squibb planning to initiate two Phase 1 studies in 2018, including a new study of an undisclosed target with Halozyme’s ENHANZE technology planned for Q2 and a study of nivolumab with ENHANZE planned for Q3.
Among the products in clinical study, Janssen continues in multiple ongoing trials of a subcutaneous formulation of DARZALEX (daratumumab) in support of plans for commercialization. Halozyme’s ENHANZE technology has the potential to enable a 15-ml injection to be delivered in five minutes or less. The ongoing or planned trials in patients with Multiple Myeloma, Amyloidosis and Smoldering Myeloma include four Phase 3 studies and two earlier stage studies.
Continued progress screening and enrolling patients in the HALO-301 study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in first-line metastatic pancreas cancer patients with high levels of tumor hyaluronan (HA-High). An interim analysis will be conducted for the first primary endpoint of PFS when the target number of events has been reached, which the company currently projects will occur between December 2018 and February 2019. Upon achieving the target number of PFS events, final data collection and the steps required for database lock prior to the interim analysis will be initiated.
Acceptance of an abstract for poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting examining Extracellular Matrix Circulating Peptide Biomarkers as Potential Predictors of Survival in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Receiving Pegvorhyaluronidase Alfa (PEGPH20), nab-Paclitaxel and Gemcitabine.
First Quarter 2018 Financial Highlights
Revenue for the first quarter was $30.9 million compared to $29.6 million for the first quarter of 2017. The year-over-year increase was driven by 50 percent growth in royalties on a reported basis from partner sales of Herceptin (trastuzumab) SC, MabThera (rituximab) SC, RITUXAN HYCELA and HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), offset by the expected decrease in bulk rHuPH20 sales to partners and research and development reimbursements. Revenue for the first quarter included $20.9 million in royalties, $3.4 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.4 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the first quarter were $38 million, compared to $36.9 million for the first quarter of 2017.
Selling, general and administrative expenses for the first quarter were $13.6 million, compared to $12.6 million for the first quarter of 2017. The increase was primarily due to personnel expenses, including stock compensation, for the period.
Net loss for the first quarter was $27.5 million, or $0.19 per share, compared to net loss in the first quarter of 2017 of $32.9 million, or $0.26 per share.
Cash, cash equivalents and marketable securities were $433.7 million at March 31, 2018, compared to $469.2 million at December 31, 2017.
Financial Outlook for 2018
Halozyme reiterated its financial guidance of:
Net revenue of $115 million to $125 million, including 25 to 30 percent royalty growth;
Operating expenses of $230 million to $240 million;
Operating cash burn of $75 million to $85 million; and
Year-end cash balance of $305 million to $315 million.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2018 today, Thursday, May 10 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording made available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 68917761.