Heron Therapeutics Announces Financial Results for the Three Months Ended March 31, 2018 and Recent Corporate Progress
Recent Corporate Progress
Pain Management Franchise
- Positive Topline Results from Pivotal Phase 3 Clinical Trials of
HTX-011 in Bunionectomy and Hernia Repair. HTX-011 achieved all
primary and key secondary endpoints in two completed pivotal Phase 3
trials, EPOCH1 for bunionectomy and EPOCH2 for hernia repair. In both
of these studies:
- HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours following surgery;
- HTX-011 significantly increased the proportion of patients who required no opioids for postoperative pain, thereby eliminating the risk of opioid-related side effects and addiction in these patients; and
- HTX-011 was well tolerated in both studies.
HTX-011 is the only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control, through 72 hours. In the second quarter of 2018, Heron expects to report topline Phase 2 data for HTX-011 in breast augmentation and total knee arthroplasty. In the second half of 2018, Heron expects to file a New Drug Application for HTX-011 with the
U.S. Food and Drug Administration( FDA).
- CINV Sales. Chemotherapy-induced nausea and vomiting (CINV)
franchise net product sales for the three months ended
March 31, 2018were $11.6 million. Heron reaffirms full-year 2018 CINV franchise net product sales guidance of $60 million to $70 million.
- SUSTOL Sales. Net product sales of SUSTOL (granisetron)
extended-release injection for the three months ended
March 31, 2018were $6.4 million. On January 1, 2018, Heron adopted Topic 606, the new revenue recognition standard now in effect. Under the prior revenue recognition standard, Heron would have recognized net product sales of $7.7 millionfor the same period. The entry of generic palonosetron in the first quarter of 2018 is expected to have a several-quarter negative impact on provider demand for SUSTOL.
- CINVANTI Sales. Net product sales of CINVANTI (aprepitant)
injectable emulsion for the three months ended
March 31, 2018were $5.2 million. CINVANTI is the only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and nausea and vomiting associated with moderately emetogenic chemotherapy (MEC). CINVANTI was approved by the FDAon November 9, 2017and became commercially available in the U.S. on January 4, 2018.
- SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended
“With more than 100 oncology clinics ordering CINVANTI in the first
quarter of launch and significant progress made toward formulary review
in the hospital segment, we are very pleased that providers are seeing
the value of CINVANTI, which is not formulated with a synthetic
“2018 is off to a great start for Heron. Our EPOCH1 and EPOCH2 Phase 3 results demonstrated HTX-011’s superiority over the standard-of-care in reducing both pain intensity and opioid use," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “Based on these results, we believe that HTX-011 can become the cornerstone of opioid-free pain management for many patients undergoing a wide range of surgical procedures.”
As of March 31, 2018, Heron had cash, cash equivalents and short-term
investments of $113.9 million. In April 2018, Heron received net cash
Net product sales for the three months ended
Heron’s net loss for the three months ended
Net cash used for operating activities for the three 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.
About CINVANTI (aprepitant) injectable emulsion
CINVANTI, in combination with other antiemetic agents, is indicated in
adults 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
nausea and vomiting in both the acute phase (0 – 24 hours after
chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy).
CINVANTI is the only IV formulation of an NK1 receptor
antagonist indicated for the prevention of acute and delayed nausea and
vomiting associated with HEC and nausea and vomiting associated with MEC
that is free of 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
trials of 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||$||11,567||$||3,632|
|Cost of product sales||3,133||1,186|
|Research and development||39,561||33,384|
|General and administrative||7,028||6,742|
|Sales and marketing||13,835||11,619|
|Total operating expenses||63,557||52,931|
|Loss from operations||(51,990||)||(49,299||)|
Other expense, net
|Basic and diluted net loss per share||$||(0.81||)||$||(1.00||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||113,938||$||172,379|
|Accounts receivable, net||37,713||41,874|
|Promissory note payable||25,000||25,000|
|Total stockholders’ equity||92,206||131,136|
Investor Relations and Media Contact:
Senior VP, General Counsel, Business Development and Corporate Secretary
Heron Therapeutics, Inc.