Heron Therapeutics Announces Fourth Quarter and Full Year 2016 Financial Results and Recent Corporate Progress
Recent Corporate Progress
- Advanced HTX-011 through Four Positive Phase 2 Studies. HTX-011 is Heron’s investigational, long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. In four Phase 2 studies, HTX-011 produced statistically significant reductions in both pain intensity and the need for opioids compared to saline placebo following procedures with incisions ranging from very large (abdominoplasty) to very small (hernia repair and bunionectomy surgeries). Statistically significant reductions in pain and opioid use were also demonstrated when compared against bupivacaine solution, the current standard-of-care. Heron anticipates initiating Phase 3 studies in 2017 and filing a New Drug Application (NDA) in 2018.
Established Synergyof Heron’s Novel Formulation of Bupivacaine and Meloxicam. HTX-011 demonstrated a statistically significant benefit over each individual component of the product alone, providing evidence of the synergistic activity of bupivacaine and meloxicam in the HTX-011 formulation.
Launched First Commercial Product, SUSTOL®.
SUSTOL (granisetron) extended-release injection 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. Heron launched SUSTOL in
October 2016, and we anticipate net sales of SUSTOL in 2017 to range from $15 to $25 million.
Submitted NDA for CINVANTITM (HTX-019). CINVANTI
is the first surfactant-free, intravenous formulation of aprepitant
for the prevention of chemotherapy-induced nausea and vomiting (CINV).
If approved by the
FDA, CINVANTI will strengthen Heron’s CINV portfolio by adding a second, complementary therapeutic agent. In January 2017, Heron submitted an NDA with the FDAfor CINVANTI and expects to receive approval in the fourth quarter of 2017.
“2016 was an exciting and transformational year for Heron, highlighted
by the release of our best-in-class Phase 2 data for HTX-011 and our
For the quarter and year ended
Our net loss for the quarter and year ended
Our net cash used for operating activities for the quarter and year
The increases in net loss and net cash used for operating activities in the 2016 periods as compared to the 2015 periods were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to the development of CINVANTI and HTX-011.
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with: the projected sufficiency of our capital position for
future periods, the potential market opportunity for SUSTOL, CINVANTI,
HTX-011 and new products generally, the sufficiency of the Phase 2 data
to allow the commencement of Phase 3 registration studies for HTX-011,
acceptance of the NDA for CINVANTI, whether the
HERON THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
|Net product sales||$||1,279||$||—||$||1,279||$||—|
|Cost of product sales||35||—||35||—|
|Research and development||29,505||16,263||103,125||61,183|
|General and administrative||5,892||6,599||21,366||18,395|
|Sales and marketing||12,650||8,198||47,668||17,347|
|Total operating expenses*||48,082||31,060||172,194||96,925|
|Loss from operations||(46,803||)||(31,060||)||(170,915||)||(96,925||)|
|Other expense, net||(1,160||)||(182||)||(2,228||)||(666||)|
|Basic and diluted net loss per share||$||(1.22||)||$||(0.87||)||$||(4.56||)||$||(2.95||)|
|Shares used in computing basic and diluted net loss per share||
* For the quarter and year ended
HERON THERAPEUTICS, INC.
Consolidated Balance Sheet Data
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||51,138||$||131,166|
|Promissory note payable||50,000||—|
|Total stockholders’ equity (deficit)||$||(21,251||)||$||118,110|
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary