Heron Therapeutics Reports Financial Results for the Three Months Ended March 31, 2017 and Recent Corporate Progress
05/10/2017
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Recent Corporate Progress
Pain Franchise
- Expanded Phase 2 Program of HTX-011 with Initiation of TKA and Nerve Block Studies. Heron initiated Phase 2 studies of HTX-011 in two new surgical models, total knee arthroplasty (TKA) and breast augmentation (pectoral pocket nerve block), to complement its four successful Phase 2 studies in abdominoplasty, bunionectomy, and hernia repair. Heron anticipates initiating Phase 3 studies of HTX-011 this year and filing a New Drug Application (NDA) in 2018.
CINV Franchise
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SUSTOL® Sales Increase; Product Added to
National Comprehensive Cancer Network (NCCN®)
Antiemesis Guidelines. Net product sales of SUSTOL
(granisetron) extended-release injection for the three months ended
March 31, 2017 were$3.6 million , compared to$1.3 million for the three months endedDecember 31, 2016 . In addition, SUSTOL was granted a Category 1 recommendation by the NCCN for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). The NCCN guidelines identify SUSTOL as a "preferred" agent for preventing CINV following MEC and highlight the unique, extended-release formulation of SUSTOL. -
Received Notice of CINVANTI™ (HTX-019) PDUFA Date.
The U.S. Food and Drug Administration (FDA ) set a Prescription Drug User Fee Act (PDUFA) goal date ofNovember 12, 2017 for a decision on the Company's NDA for CINVANTI. If approved, CINVANTI will strengthen Heron's CINV portfolio by adding a second, complementary therapeutic agent in this category.
"The first quarter of 2017 was a productive period for Heron, highlighted by the completion of several highly-successful Phase 2 studies of HTX-011 in multiple post-operative pain models and the inclusion of SUSTOL in the NCCN guidelines," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "Looking ahead, we are focused on the commencement of Phase 3 studies of HTX-011, as well as the approval of CINVANTI by year-end 2017."
Financial Results
In
Net product sales of SUSTOL for the three months ended
Heron's net loss for the three months ended
Heron's net cash used for operating activities for the three months
ended
The increases in net loss and net cash used for operating activities for
the three months ended
About
Forward-Looking Statements
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 market opportunity for SUSTOL, CINVANTI, HTX-011 and
new products generally, timing of potential generic forms of
palonosetron and the potential impact on sales of SUSTOL, the timing and
outcome of the End of Phase 2 meeting with the
HERON THERAPEUTICS, INC. | ||||||||||
Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Three Months Ended | ||||||||||
March 31, | ||||||||||
(unaudited) | ||||||||||
2017 | 2016 | |||||||||
Revenues: | ||||||||||
Net product sales | $ | 3,632 | $ | — | ||||||
Operating expenses: | ||||||||||
Cost of product sales | 1,186 | — | ||||||||
Research and development | 33,384 | 16,092 | ||||||||
General and administrative | 6,742 | 5,367 | ||||||||
Sales and marketing | 11,619 | 11,853 | ||||||||
Total operating expenses* | 52,931 | 33,312 | ||||||||
Loss from operations | (49,299 | ) | (33,312 | ) | ||||||
Other expense, net | (1,030 | ) | (133 | ) | ||||||
Net loss | $ | (50,329 | ) | $ | (33,445 | ) | ||||
Basic and diluted net loss per share | $ | (1.00 | ) | $ | (0.92 | ) | ||||
Shares used in computing basic and diluted net loss per share | 50,530 | 36,229 |
* For the three months ended March 31, 2017, operating expenses included non-cash, stock-based compensation expense of $8.0 million compared to $5.4 million for the same period in 2016. |
HERON THERAPEUTICS, INC. |
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Consolidated Balance Sheet Data |
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(in thousands) |
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March 31, |
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(unaudited) |
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2017 |
2016 |
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Cash, cash equivalents and short-term investments | $ | 165,216 | $ | 51,138 | |||||
Total assets | 189,558 | 67,482 | |||||||
Promissory note payable | 50,000 | 50,000 | |||||||
Total stockholders' equity (deficit) | $ | 102,160 | $ | (21,251 | ) | ||||
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Source:
Investor Relations and Media Contact:
David Szekeres,
858-251-4447
Senior VP, General Counsel, Business Development and
Corporate Secretary
dszekeres@herontx.com