Heron Therapeutics Reports Financial Results for the Three and Nine Months Ended September 30, 2017 and Recent Corporate Progress
Recent Corporate Progress
- Initiated Phase 3
Program for HTX-011in Postoperative Pain. Heron is enrolling patients in two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron’s Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain and the need for opioid analgesics for 72 hours following surgery. Heron anticipates completing the pivotal Phase 3 efficacy studies in the first half of 2018 and expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration( FDA) in 2018.
- Fast Track Designation Granted for HTX-011. The
FDAhas granted Fast Track designation for HTX-011 for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is intended to facilitate the development and expedite the review of new therapies to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA. HTX-011 is the first opioid alternative for local administration into the surgical site to receive Fast Track designation.
- Patent Issued Covering Novel Bupivacaine/Meloxicam Combination. The U.S. Patent and Trademark Office issued to Heron U.S. Patent No. 9,801,945, which covers HTX-011 and all clinically relevant combinations of bupivacaine and meloxicam for the prevention of postoperative pain.
- SUSTOL® Sales. Net product sales of
SUSTOL (granisetron) extended-release injection for the three and nine
September 30, 2017were $8.6 millionand $20.7 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Guidance for full-year 2017 net product sales of SUSTOL remains $25 million to $30 million.
- CINVANTI™ FDA Action Date in Q4 2017. The
FDAset a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017for a decision on the Company’s NDA for CINVANTI.
“Heron made good progress in the third quarter of 2017, highlighted by
the start of Phase 3 studies for HTX-011, which recently has been
granted Fast Track designation, and SUSTOL’s continued commercial
success, outperforming all other CINV new drug launches in the last
decade,” said Barry D. Quart, Pharm.D., Chief Executive Officer of
Heron. “Looking ahead, we are focused on
Net product sales of SUSTOL for the three months ended
Heron’s net loss for the three and nine months ended
Heron’s cash, cash equivalents and short-term investments were
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with: our capital position and the sufficiency of our capital
to fund our operations in future periods; the market opportunity for
SUSTOL; whether the
HERON THERAPEUTICS, INC.
Three Months Ended
Nine Months Ended
|Net product sales||$||8,572||$||-||$||20,714||$||-|
|Cost of product sales||1,051||-||3,250||-|
|Research and development||28,844||30,242||90,825||73,620|
|General and administrative||6,462||5,333||19,389||15,474|
|Sales and marketing||13,529||12,159||39,918||35,018|
|Total operating expenses||49,886||47,734||153,382||124,112|
|Loss from operations||(41,314||)||(47,734||)||(132,668||)||(124,112||)|
|Interest expense, net||(552||)||(775||)||(2,326||)||(1,068||)|
|Basic and diluted net loss per share||$||(0.77||)||$||(1.24||)||$||(2.55||)||$||(3.34||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||74,016||$||51,138|
|Accounts receivable, net||28,851||1,960|
|Promissory note payable||25,000||50,000|
|Total stockholders’ equity (deficit)||40,053||(21,251||)|
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary