Heron Therapeutics Reports Financial Results for the Three and Six Months Ended June 30, 2017 and Recent Corporate Progress
-Strong SUSTOL Sales; Guidance Increased for 2017-
Recent Corporate Progress
Initiation of Phase 3
Program for HTX-011in Postoperative Pain Following Successful End-of-Phase 2 Meeting with FDA. Heron reached a general agreement with the U.S. Food and Drug Administration( FDA) on the design and key elements for HTX-011’s Phase 3 program that will be required to support a New Drug Application (NDA). The program includes two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair and an approximately 200-patient Phase 3 safety and pharmacokinetics study to meet the target patient numbers established by the FDAand to provide further evidence of the broad utility of HTX-011 across multiple surgical models. Importantly, the FDAnoted that, beyond the agreed-upon Phase 3 studies, no additional clinical work is needed to meet the “Combination Rule” for fixed-dose combination products. The Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain for 72 hours and reduce the need for opioid analgesic medications following surgery. Heron recently initiated patient enrollment in its Phase 3 program and anticipates completing the Phase 3 program in the first half of 2018. Heron expects to file an NDA in 2018.
Hired Key Talent.
Anita Gupta, D.O., Pharm.D. joined Heron as Senior Vice President, Medical Strategy and Government Affairs and will be a key team member providing medical and regulatory input, and working with governmental agencies to support the use of opioid alternatives for postoperative pain. Dr. Gupta has led influential research, advocacy, community and healthcare policy efforts in pain medicine, anesthesiology and opioid prevention. Dr. Gupta is a board-certified anesthesiologist and internationally recognized pain specialist. She recently served as a member of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committeeand is a fellow at Princeton Universityat the Woodrow Wilson School.
SUSTOL® Sales Increase. Net product
sales of SUSTOL (granisetron) extended-release injection for the three
June 30, 2017were $8.5 million, compared to $3.6 millionfor the three months ended March 31, 2017.
SUSTOL Guidance Increased. Based on results for the first half
of 2017, Heron has increased its full year 2017 net product sales of
SUSTOL guidance to a range of
$25 to $30 million.
CINVANTI™ (HTX-019) FDA Action Date in Q4 2017. The
FDAset a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017for a decision on the Company’s NDA for CINVANTI.
“The first half of 2017 has been very exciting for Heron with the submission of the CINVANTI NDA, a successful End-of-Phase 2 meeting for HTX-011, and the excellent growth in net product sales of SUSTOL,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We have made important progress in the launch of SUSTOL and plan to build upon our success with the anticipated approval of CINVANTI by year-end 2017, which would add a second, complementary commercial product.”
Net product sales of SUSTOL for the three months ended
Heron’s net loss for the three and six months ended
Heron’s net cash used for operating activities for the three months
Heron believes that its cash, cash equivalents and short-term
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with: our capital position and the sufficiency of our capital
to fund our operations in future periods, the market opportunity for
SUSTOL, whether the
HERON THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
Six Months Ended
|Net product sales||$||8,510||$||-||$||12,142||$||-|
|Cost of product sales||1,013||-||2,199||-|
|Research and development||28,597||27,286||61,981||43,378|
|General and administrative||6,185||4,774||12,927||10,141|
|Sales and marketing||14,770||11,006||26,389||22,859|
|Total operating expenses||50,565||43,066||103,496||76,378|
|Loss from operations||(42,055||)||(43,066||)||(91,354||)||(76,378||)|
|Interest expense, net||(744||)||(160||)||(1,774||)||(293||)|
|Basic and diluted net loss per share||$||(0.80||)||$||(1.17||)||$||(1.79||)||$||(2.09||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||109,263||$||51,138|
|Accounts receivable, net||18,616||1,960|
|Promissory note payable||25,000||50,000|
|Total stockholders’ equity (deficit)||$||69,075||$||(21,251||)|
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary