Heron Therapeutics Announces Fourth Quarter and Full Year 2015 Financial Results and Recent Corporate Progress
Recent Corporate Progress:
February 2016, Heron successfully demonstrated bioequivalence of HTX-019 to intravenous (IV) fosaprepitant in a study that included 100 healthy volunteers. In this study, HTX-019 demonstrated a substantially improved safety profile compared to IV fosaprepitant, which contains polysorbate 80. HTX-019, a polysorbate 80-free, IV formulation of the neurokinin-1 (NK1) receptor antagonist aprepitant, is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).
February 2016, Heron initiated a placebo-controlled, dose-finding, Phase 2 clinical trial of HTX-011 for the treatment of post-operative pain in approximately 100 patients undergoing abdominoplasty. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam formulated with Heron’s Biochronomer® drug delivery technology.
January 2016, the U.S. Food and Drug Administration( FDA) informed Heron that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection, extended release and was unable to take action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. The FDAstated that it is targeting taking action in late February 2016.
“While we were disappointed that the
Results of Operations
Heron’s net cash used for operating activities for the quarter and year
Heron’s net loss for the quarter and year ended
The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 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 1 and 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: whether the
|HERON THERAPEUTICS, INC.|
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
|December 31,||Years Ended|
|Research and development||$||16,263||$||14,195||$||61,183||$||54,833|
|General and administrative||14,797||5,300||35,742||19,728|
Total operating expenses
|Loss from operations||(31,060)||(19,495)||(96,925)||(74,561)|
|Other expense, net||(182)||(1,129)||(666)||(1,806)|
|Basic and diluted net loss per share||$||(0.87)||$||(0.71)||$||(2.95)||$||(2.87)|
|Shares used in computing basic and diluted net loss per share||
|HERON THERAPEUTICS, INC.|
Condensed Consolidated Balance Sheet Data
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||131,166||$||72,675|
|Total stockholders’ equity||$||118,110||$||63,062|
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