Heron Therapeutics Reports Financial Results for the Three Months Ended March 31, 2017 and Recent Corporate
Progress
Heron Therapeutics, Inc. (Nasdaq:HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing
novel best-in-class treatments to address some of the biggest unmet patient needs, today reported financial results for the three
months ended March 31, 2017 and highlighted recent corporate progress.
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
- 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 ended December 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 of November 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 January 2017, Heron completed an underwritten public offering of its common stock for net proceeds of $163.7 million. As of
March 31, 2017, the Company had cash, cash equivalents and short-term investments of $165.2 million, compared to $51.1 million as
of December 31, 2016. Based on the Company’s current operating plan and projections, it believes that available cash, cash
equivalents and short-term investments are sufficient to fund operations for at least one year.
Net product sales of SUSTOL for the three months ended March 31, 2017 were $3.6 million, which represents 184% sequential
quarter-over-quarter growth over the $1.3 million of net product sales of SUSTOL for the three months ended December 31, 2016.
Heron’s net loss for the three months ended March 31, 2017 was $50.3 million, or $1.00 per share, compared to $33.4 million, or
$0.92 per share for the same period in 2016. Net loss for the three months ended March 31, 2017, included non-cash, stock-based
compensation expense of $8.0 million compared to $5.4 million for the same period in 2016.
Heron’s net cash used for operating activities for the three months ended March 31, 2017 was $50.6 million, compared to $32.4
million for the same period in 2016.
The increases in net loss and net cash used for operating activities for the three months ended March 31, 2017 compared to the
same period in 2016 were primarily due to increased clinical and manufacturing costs related to the development of HTX-011 and
CINVANTI.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing
best-in-class treatments that address some of the biggest unmet patient needs. Heron is developing novel, patient-focused solutions
that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or
pain. For more information, visit www.herontx.com.
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 FDA for HTX-011, whether the
FDA approves the CINVANTI NDA as submitted, the timing of the NDA filing 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 with the Securities and Exchange
Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or
revise these statements except as may be required by law.
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| HERON THERAPEUTICS, INC. |
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Consolidated Statements of Operations
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(in thousands, except per share amounts)
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Three Months Ended |
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March 31, |
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(unaudited) |
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2017 |
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2016 |
| Revenues: |
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| Net product sales |
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$ |
3,632 |
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$ |
— |
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| Operating expenses: |
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| Cost of product sales |
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1,186 |
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— |
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| Research and development |
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33,384 |
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16,092 |
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| General and administrative |
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6,742 |
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5,367 |
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| Sales and marketing |
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11,619 |
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11,853 |
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| Total operating expenses* |
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52,931 |
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33,312 |
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| Loss from operations |
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(49,299 |
) |
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(33,312 |
) |
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| Other expense, net |
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(1,030 |
) |
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(133 |
) |
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| Net loss |
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$ |
(50,329 |
) |
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$ |
(33,445 |
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| Basic and diluted net loss per share |
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$ |
(1.00 |
) |
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$ |
(0.92 |
) |
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| Shares used in computing basic and diluted net loss per share |
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50,530 |
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36,229 |
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| * For the three months ended March 31, 2017, operating expenses included non-cash,
stock-based compensation expense of $8.0 million compared to $5.4 million for the same period in 2016. |
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HERON THERAPEUTICS, INC.
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Consolidated Balance Sheet Data
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(in thousands)
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March 31,
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(unaudited)
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2017
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2016
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| Cash, cash equivalents and short-term investments |
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$ |
165,216 |
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$ |
51,138 |
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| Total assets |
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189,558 |
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67,482 |
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| Promissory note payable |
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50,000 |
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50,000 |
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| Total stockholders’ equity (deficit) |
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$ |
102,160 |
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$ |
(21,251 |
) |
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Investor Relations and Media Contact:
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary
dszekeres@herontx.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20170510005461/en/