Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2017 and Recent Corporate Progress
Recent Corporate Progress
- SUSTOL® Sales. Net product sales of SUSTOL
(granisetron) extended-release injection for the three months ended
December 31, 2017were $10.1 million, up 17% from the net product sales for the three months ended September 30, 2017of $8.6 million. SUSTOL net product sales for the twelve months ended December 31, 2017were $30.8 million, versus guidance of $25 million to $30 million.
- 2018 CINV Sales Guidance. Net product sales guidance for
full-year 2018 for the CINV franchise is
$60 million to $70 million.
- Permanent J-Code Now Effective. On
January 1, 2018,a product-specific billing code, or permanent J-code, for SUSTOL became available. The new J-code was assigned by the Centers for Medicare and Medicaid Services(CMS) and will help simplify the billing and reimbursement process for prescribers of SUSTOL.
- CINVANTI™ Now Available. In
November 2017, the U.S. Food and Drug Administration( FDA) approved the Company’s New Drug Application (NDA) for CINVANTI (aprepitant) injectable emulsion, the first and only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI became commercially available in the United Stateson January 4, 2018.
Pain Management Franchise
- Enrollment Complete in Phase 3 Pivotal Trials for HTX-011 in
Postoperative Pain. Heron completed enrollment in its two pivotal
Phase 3 efficacy studies in bunionectomy and hernia repair. Heron
anticipates reporting top-line results in the first half of 2018 and
expects to file an NDA with the
FDAin the second half of 2018.
“2017 was an excellent year for Heron, with significant progress in both our CINV and pain management franchises,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “2018 should be an equally exciting year as we look forward to reporting top-line pivotal Phase 3 data and filing an NDA for HTX-011, while continuing to ramp up net product sales for our CINV franchise.”
Net product sales of SUSTOL for the three and twelve months ended
Heron’s net loss for the three and twelve months ended
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is an investigational, long-acting,
extended-release formulation of the local anesthetic bupivacaine in a
fixed-dose combination with the anti-inflammatory meloxicam for the
prevention of postoperative pain. By delivering sustained levels of both
a potent anesthetic and a local anti-inflammatory agent directly to the
site of tissue injury, HTX-011 was designed to deliver superior pain
relief while reducing the need for systemically administered pain
medications such as opioids, which carry the risk of harmful side
effects, abuse and addiction. The Phase 2 development program for
HTX-011 was designed to target the many patients undergoing a wide range
of surgeries who experience significant postoperative pain. Heron
completed enrollment in its two pivotal Phase 3 efficacy studies in
bunionectomy and hernia repair and anticipates reporting top-line
results in the first half of 2018 and expects to file an NDA with the
About CINVANTI (aprepitant) injectable emulsion
CINVANTI is indicated in adults, in combination with other antiemetic
agents, for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of highly emetogenic cancer
chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of
aprepitant, a substance P/neurokinin-1 (NK1) receptor
antagonist. CINVANTI is the first intravenous (IV) formulation to
directly deliver aprepitant, the active ingredient in EMEND®
capsules. Aprepitant (including its prodrug, fosaprepitant) is the only
single-agent NK1 receptor antagonist to significantly reduce
CINV in both the acute phase (0 – 24 hours after chemotherapy) and the
delayed phase (24 – 120 hours after chemotherapy). CINVANTI does not
contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical
formulations containing polysorbate 80 have been linked to
hypersensitivity reactions, including anaphylaxis and irritation of
blood vessels resulting in infusion-site pain.
Please see Full Prescribing Information at www.CINVANTI.com.
About SUSTOL (granisetron) extended-release injection
SUSTOL 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. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).
Please see Full Prescribing Information at www.SUSTOL.com.
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 2018 net product sales
guidance for the CINV franchise; the timing of completion and results of
the Phase 3 trials for HTX-011; the timing of the HTX-011 NDA filing and
review process; and other risks and uncertainties identified in the
Company's filings with the
HERON THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
|Net product sales||$||10,053||$||1,279||$||30,767||$||1,279|
|Cost of product sales||1,338||35||4,588||35|
|Research and development||47,757||29,505||138,582||103,125|
|General and administrative||6,165||5,892||25,554||21,366|
|Sales and marketing||16,683||12,650||56,601||47,668|
|Total operating expenses||71,943||48,082||225,325||172,194|
|Loss from operations||(61,890||)||(46,803||)||(194,558||)||(170,915||)|
|Interest expense, net||(600||)||(1,160||)||(2,926||)||(2,228||)|
|Basic and diluted net loss per share||$||(1.09||)||$||(1.22||)||$||(3.65||)||$||(4.56||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||172,379||$||51,138|
|Accounts receivable, net||41,874||1,960|
|Promissory note payable||25,000||50,000|
|Total stockholders’ equity (deficit)||131,136||(21,251||)|
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary