Heron Therapeutics Announces Financial Results for the Three and Six Months Ended June 30, 2019 and Highlights Recent Corporate Updates
08/05/2019
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Recent Corporate Updates
Pain Management Franchise
- Complete Response Letter Received from the FDA Regarding the NDA for HTX-011: A Complete Response Letter (CRL) was received from the
U.S. Food and Drug Administration (FDA ) onApril 30, 2019 regarding the Company's New Drug Application (NDA) for HTX-011 for postoperative pain management. The CRL stated that theFDA is unable to approve the NDA in its present form based on the need for additional Chemistry, Manufacturing and Controls (CMC) and non-clinical information. Based on the complete review of the NDA, theFDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses. - 95% of Postoperative Patients Remain Opioid-Free when HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in Real-world Study in Hernia Repair Surgery: In
May 2019 , we announced the results of a multi-center postoperative pain management study in 93 patients that provides real-world evidence of opioid-free recovery in patients undergoing outpatient inguinal hernia repair surgery who received the investigational agent, HTX-011, together with a scheduled background regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). Ninety-one percent (91%) of patients receiving HTX-011 with the OTC analgesic regimen were discharged without an opioid prescription, and none of these patients subsequently requested an opioid for postoperative pain. - Results of Phase 3 EPOCH 1 Study Published: In
May 2019 , the results from the pivotal Phase 3 EPOCH 1 bunionectomy study of HTX-011 were published by the Regional Anesthesia & Pain Medicine journal.
CINV Franchise
- CINV 2019 Net Product Sales: For the three months ended
June 30, 2019 , chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were$36.7 million , up 112% from the same period in 2018, and up 16% from the three months endedMarch 31, 2019 . For the six months endedJune 30, 2019 , CINV franchise net product sales were$68.3 million , up 137% from the same period in 2018. Heron reaffirms full-year 2019 CINV franchise net product sales guidance of$115 million to $120 million . - CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended
June 30, 2019 were$33.2 million and$61.2 million , respectively, compared to$11.2 million and$16.4 million , respectively, for the same periods in 2018. - SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended
June 30, 2019 were$3.5 million and$7.1 million , respectively, compared to$6.1 million and$12.4 million for the same periods in 2018.
"We expect to meet with the
Financial Results
Net product sales for the three and six months ended
Heron's net loss for the three and six months ended
As of June 30, 2019, Heron had cash, cash equivalents and short-term investments of $276.0 million, compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the six 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 management 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. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA for HTX-011 to the FDA in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the
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 IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA 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 RA 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. The
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® 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.
About
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 full-year 2019 net product sales guidance for the CINV franchise; whether the
HERON THERAPEUTICS, INC. |
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Condensed Consolidated Statements of Operations |
|||||||
(in thousands, except per share amounts) |
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Three Months Ended |
Six Months Ended |
||||||
2019 |
2018 |
2019 |
2018 |
||||
Revenues: |
|||||||
Net product sales |
$ 36,659 |
$ 17,277 |
$ 68,261 |
$ 28,844 |
|||
Operating expenses: |
|||||||
Cost of product sales |
13,588 |
5,231 |
28,550 |
8,364 |
|||
Research and development |
41,425 |
30,159 |
84,397 |
69,720 |
|||
General and administrative |
9,778 |
6,209 |
19,426 |
13,237 |
|||
Sales and marketing |
23,647 |
14,531 |
52,367 |
28,366 |
|||
Total operating expenses |
88,438 |
56,130 |
184,740 |
119,687 |
|||
Loss from operations |
(51,779) |
(38,853) |
(116,479) |
(90,843) |
|||
Other income (expense), net |
1,557 |
183 |
3,245 |
(92) |
|||
Net loss |
$ (50,222) |
$ (38,670) |
$ (113,234) |
$ (90,935) |
|||
Basic and diluted net loss per share |
$ (0.63) |
$ (0.54) |
$ (1.43) |
$ (1.33) |
|||
Shares used in computing basic and diluted net loss per share |
79,548 |
71,952 |
78,987 |
68,358 |
HERON THERAPEUTICS, INC. |
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Condensed Consolidated Balance Sheet Data |
|||
(in thousands) |
|||
June 30, |
December 31, |
||
2019 |
2018 |
||
(unaudited) |
|||
Cash, cash equivalents and short-term investments |
$ 276,005 |
$ 332,371 |
|
Accounts receivable, net |
66,821 |
64,652 |
|
Total assets |
411,666 |
462,179 |
|
Total stockholders' equity |
305,359 |
370,160 |
Investor Relations and Media Contact:
Senior VP, General Counsel, Business Development and Corporate Secretary
dszekeres@herontx.com
858-251-4447
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