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In July 2019, ENHANZE® collaborator Janssen Biotech, Inc. (Janssen) submitted a Biologics License Application to the U.S. Food and Drug Administration and an extension application to the European Medicines Agency for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma. Janssen’s regulatory submissions followed the announcement and subsequent presentation of positive results from its phase 3 COLUMBA study at the American Society of Clinical Oncology Annual Meeting in June 2019. The COLUMBA study investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed or refractory multiple myeloma.
In July 2019, argenx dosed the first subject in a phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113), using Halozyme's proprietary ENHANZE® drug delivery technology, triggering a $5 million payment to Halozyme. Additionally, in May 2019, argenx nominated a second target to be studied using ENHANZE® technology, a human complement factor C2 associated with the product
In June 2019, the target number of 330 overall survival events in the HALO-301 clinical trial was reached. The company plans to conduct the final overall survival analysis upon data maturity which will occur when all patients enrolled in the study have been followed for at least 8.5 months. Accordingly, data maturity is projected to be achieved in mid-September 2019. Based on this timing of data maturity, the company expects to announce topline results for the HALO-301 clinical trial by December 2019.
In June 2019, a Cooperative Research and Development Agreement (CRADA) was announced with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC), part of the National Institute of Health, enabling the VRC’s use of ENHANZE® technology to develop subcutaneous formulations of broadly neutralizing antibodies (bnAbs) against HIV for HIV treatment.
Revenue for the second quarter was $39.1 million compared to $35.2 million for the second quarter of 2018. The year-over-year increase was primarily driven by higher ENHANZE® license payments. Revenue for the quarter included $18.1 million in royalties and $5.8 million in product sales, which compared to $20.0 million and $4.5 million, respectively, in the prior year period. The decrease in royalties was mainly driven by lower sales of Herceptin® SC by Roche, partially offset by higher sales of RITUXAN HYCELA™ in the U.S. by Roche and higher sales of HyQvia by Takeda.
Research and development expenses for the second quarter were $33.9 million, compared to $40.1 million for the second quarter of 2018. The decline in expenses was driven by reduced clinical trial activity due to the completion of enrollment in HALO-301.
Selling, general and administrative expenses for the second quarter were $17.3 million, compared to $14.4 million for the second quarter of 2018. The increase is related to an increase in personnel expenses as well as preparations for the potential commercial launch of PEGPH20.
Net loss for the second quarter was $14.6 million, or $0.10 per share, compared to a net loss in the second quarter of 2018 of $22.9 million, or $0.16 per share.
Cash, cash equivalents and marketable securities were $287.5 million at June 30, 2019, compared to $354.5 million at December 31, 2018.
Total revenues unchanged from prior guidance of $205 million to $215 million, including revenue from royalties of $72 million to $74 million;
Operating expenses of $255 million to $265 million, down from prior guidance of $265 million to $275 million, or operating expenses excluding cost of goods sold $215 million to $225;
Operating cash burn of $40 million to $50 million, down from prior guidance of $45 million to $55 million;
Debt repayment of approximately $90 million; the company now expects to pay off the remainder of the royalty-backed debt by the end of the second quarter of 2020;
Year-end cash, cash equivalents and marketable securities balance of $220 million to $230 million, up from prior guidance of $210 million to $220 million.
Three Months Ended
Six Months Ended
Product sales, net
Revenues under collaborative agreements
Cost of product sales
Research and development
Selling, general and administrative
Total operating expenses
Other income (expense):
Investment and other income, net
Net loss before income taxes
Income tax expense
Net loss per share:
Basic and diluted
Shares used in computing net loss per share:
Basic and diluted
Cash and cash equivalents
Marketable securities, available-for-sale
Accounts receivable, net and other contract assets
Prepaid expenses and other assets
Total current assets
Property and equipment, net
Prepaid expenses and other assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Deferred revenue, current portion
Current portion of long-term debt, net
Total current liabilities
Deferred revenue, net of current portion
Long-term debt, net
Other long-term liabilities
Additional paid-in capital
Accumulated other comprehensive income (loss)
Total stockholders’ equity
Total liabilities and stockholders’ equity
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