Heron Therapeutics Announces First Quarter 2016 Financial Results and Recent Corporate Progress
Recent Corporate Progress:
April 18, 2016, Heron announced that the U.S. Food and Drug Administration( FDA) has indicated that there are no substantive deficiencies in the New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release, Heron’s lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients, and has begun labeling discussions with the Company.
Heron has continued to implement a broad-based Phase 2 clinical
program of HTX-011, its lead product candidate for the prevention of
post-operative pain. In
February 2016, Heron initiated a Phase 2 clinical trial of HTX-011 in patients undergoing abdominoplasty, and in April 2016, Heron initiated a Phase 2 clinical trial of HTX-011 in patients undergoing bunionectomy. In addition, the Company continues to enroll patients in an ongoing Phase 2 clinical trial in patients undergoing inguinal hernia repair.
“We continue to work closely with the
Results of Operations
Heron’s net cash used for operating activities for the quarter ended
Heron’s net loss for the quarter ended
The increase in net cash used for operating activities and net loss in the first quarter of 2016 as compared to the same period in 2015 were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to our Phase 2 clinical studies for HTX-011 and costs associated with the development of HTX-019.
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, but
are not limited to, those associated with: financial estimates, the
projected sufficiency of our capital position for future periods, the
review of the SUSTOL NDA by the
HERON THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended|
|Research and development||$||16,092||$||14,504|
|General and administrative||5,367||3,587|
|Sales and marketing||11,853||2,269|
|Total operating expenses||33,312||20,360|
|Loss from operations||(33,312||)||(20,360||)|
|Interest expense, net||(133||)||(210||)|
|Basic and diluted net loss per share||$||(0.92||)||$||(0.70||)|
|Shares used in computing basic and diluted net loss per share||36,229||29,392|
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||100,407||$||131,166|
|Total stockholders’ equity||$||92,676||$||118,110|
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations
Barry D. Quart, 650-366-2626
Pharm D., Chief Executive Officer