Heron Therapeutics Reports Financial Results for the Three and Nine Months Ended September 30, 2016 and Recent Corporate Progress
Recent Corporate Progress:
Heron commenced U.S. commercial sales of SUSTOL® (granisetron)
extended-release injection in
October 2016. SUSTOL was approved by the U.S. Food and Drug Administrationin August 2016. SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
- Positive results from the Company's Phase 2 clinical study of HTX-011, its lead product candidate for the management of post-operative pain, in patients undergoing inguinal hernia repair (Study 202) were presented at PAINWeek 2016. The primary and important secondary endpoints were achieved, and HTX-011 was generally well tolerated. Furthermore, HTX-011 administered via instillation was shown to be equally effective to administration via injection.
- Heron reported positive, top-line results from the Company's second Phase 2 clinical study of HTX-011 in patients undergoing bunionectomy (Study 208). The primary and important secondary endpoints were achieved, and HTX-011 was generally well tolerated.
“The second half of 2016 is off to an exciting start for Heron,
highlighted by the
Results of Operations
Heron’s net cash used for operating activities for the three and nine
Heron’s net loss for the three and nine months ended
The increases in net cash used for operating activities and net loss in the 2016 periods as compared to the 2015 periods were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to the development of HTX-019 and HTX-011.
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: the projected sufficiency of
our capital position for future periods, our ability to repay any
indebtedness, the potential market opportunity for SUSTOL, HTX-011,
HTX-019 and new products generally, the timing of the NDA filing for
HTX-019, whether the Phase 2 study results are indicative of the results
in future studies related to HTX-011, the sufficiency of the Phase 2
data to allow the commencement of Phase 3 registration studies for
HTX-011, the progress in the research and development of HTX-011 and our
other programs, including the timing of preclinical, clinical, and
manufacturing activities, safety and efficacy results from our studies,
and other risks and uncertainties identified in the Company's filings
HERON THERAPEUTICS, INC.
Three Months Ended
Nine Months Ended
|Research and development||$||30,242||$||14,241||$||73,620||$||44,920|
|General and administrative||5,333||4,127||15,474||11,796|
|Sales and marketing||12,159||4,123||35,018||9,149|
|Total operating expenses||47,734||22,491||124,112||65,865|
|Loss from operations||(47,734||)||(22,491||)||(124,112||)||(65,865||)|
|Other expense, net||(775||)||(181||)||(1,068||)||(484||)|
|Basic and diluted net loss per share||$||(1.24||)||$||(0.63||)||$||(3.34||)||$||(2.07||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||88,919||$||131,166|
|Promissory note payable||50,000||—|
|Total stockholders’ equity||$||17,880||$||118,110|
Heron Therapeutics, Inc.
Investor Relations and Media Contact:
David Szekeres, 858-356-4778
SVP, General Counsel, Business Development & Corporate Secretary