SAN DIEGO, Feb. 22, 2019 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company focused on improving the lives of patients by developing
best-in-class treatments to address some of the most important
unmet patient needs, today reported financial results for the three
and twelve months ended December 31,
2018 and highlighted recent corporate progress.
Recent Corporate Progress
Pain Management Franchise
- Acceptance of HTX-011 NDA for Postoperative Pain Management
with Priority Review Designation; PDUFA Date of April 30, 2019: The U.S. Food and Drug
Administration (FDA) recently accepted the new drug application
(NDA) for Heron's investigational agent, HTX-011, and has granted
it a Priority Review designation. The FDA set a Prescription Drug
User Fee Act (PDUFA) goal date of April 30,
2019 and indicated that it is not currently planning an
advisory committee meeting to discuss this application.
- 90% of Patients Treated with HTX-011 Opioid-Free 72 Hours
Post-Surgery in New Multi-center Clinical Study: In this study,
63 patients undergoing hernia repair surgery received HTX-011
together with a regimen of generic, over-the-counter, oral
analgesics (acetaminophen and ibuprofen). Ninety percent (90%) of
patients were opioid-free 72 hours post-surgery, and 81% were still
opioid-free 28 days post-surgery.
- Formal Development Initiated on HTX-034, Our Next-Generation
Product Candidate for Postoperative Pain Management: Based on
the positive results of preclinical studies in which HTX-034
demonstrated significant pain reduction for 7 days, Heron has
initiated formal development of this next-generation postoperative
pain management product candidate.
CINV Franchise
- 2018 Net Sales: Fourth-quarter 2018 net sales for the
chemotherapy-induced nausea and vomiting (CINV) franchise were
$28.8 million, up 187% year-over-year
and up 46% from the third quarter of 2018. This included net sales
of $23.4 million for
CINVANTI® (aprepitant) injectable emulsion and
$5.4 million for SUSTOL®
(granisetron) extended-release injection. Full-year 2018 net sales
for the CINV franchise were $77.5
million, up 152% year-over-year. This included net sales of
$56.2 million for CINVANTI and
$21.3 million for SUSTOL.
- 2019 Net Sales Guidance: Heron expects 2019 net sales
for the CINV franchise of $115
million to $120 million.
"2018 was a year of significant growth for our CINV franchise,
and we look forward to continued strong performance this
year," said Barry Quart, Pharm.D., President and Chief
Executive Officer of Heron. "In pain management, Heron remains
committed to making a significant impact on the opioid epidemic
through the development and commercialization of innovative
non-opioid pain management products. With a PDUFA goal date of
April 30, 2019, we look forward to
launching HTX-011 in the U.S. later this year, if approved."
Financial Results
Net product sales for the three and twelve months ended
December 31, 2018 were $28.8 million and $77.5
million, respectively, compared to $10.1 million and $30.8
million for the same periods in 2017, respectively.
Heron's net loss for the three and twelve months ended
December 31, 2018 was $49.6 million and $178.8
million, or $0.63 per share
and $2.44 per share, respectively,
compared to $62.5 million and
$197.5 million, or $1.09 per share and $3.65 per share, for the same periods in 2017,
respectively. Net loss for the three and twelve months ended
December 31, 2018 included non-cash,
stock-based compensation expense of $9.8
million and $33.4 million,
respectively, compared to $6.9
million and $30.5 million, for
the same periods in 2017, respectively.
As of December 31, 2018, Heron had cash, cash equivalents
and short-term investments of $332.4 million, compared
to $172.4 million as of December 31, 2017. Net
cash used for operating activities for the three and twelve months
ended December 31, 2018 was
$33.5 million and $191.8 million, respectively, compared to
$47.1 million and $170.3 million for the same periods in 2017,
respectively.
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 postoperative pain management. 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 to the FDA for HTX-011 in October
of 2018 and received Priority Review designation in December of
2018. The FDA set a PDUFA goal date of April
30, 2019.
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. FDA-approved dosing
administration included in the United
States prescribing information for CINVANTI is a 30-minute
infusion.
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 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 to address some of the most important
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
pain or cancer.
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
sales guidance for the CINV franchise; whether the FDA approves the
HTX-011 NDA as submitted; the timing of the FDA's review process
for HTX-011; whether the FDA will require an advisory committee
meeting for HTX-011 in the future; the anticipated commercial
launch of HTX-011; the timing and results of the studies in the
HTX-034 development program; and other risks and uncertainties
identified in the Company's filings with the U.S. 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.
HERON
THERAPEUTICS, INC.
|
Condensed
Consolidated Statements of Operations
|
(in thousands, except
per share amounts)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Net
product sales
|
$ 28,844
|
|
$
10,053
|
|
$
77,474
|
|
$
30,767
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
product sales
|
11,572
|
|
1,338
|
|
27,512
|
|
4,588
|
Research
and development
|
39,891
|
|
47,757
|
|
140,032
|
|
138,582
|
General
and administrative
|
8,738
|
|
6,165
|
|
29,263
|
|
25,554
|
Sales
and marketing
|
19,957
|
|
16,683
|
|
64,604
|
|
56,601
|
Total operating
expenses
|
80,158
|
|
71,943
|
|
261,411
|
|
225,325
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(51,314)
|
|
(61,890)
|
|
(183,937)
|
|
(194,558)
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
1,755
|
|
(600)
|
|
5,097
|
|
(2,926)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(49,559)
|
|
$
(62,490)
|
|
$
(178,840)
|
|
$(197,484)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.63)
|
|
$
(1.09)
|
|
$
(2.44)
|
|
$
(3.65)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and
diluted net loss per share
|
78,086
|
|
57,585
|
|
73,193
|
|
54,040
|
HERON
THERAPEUTICS, INC.
|
Condensed
Consolidated Balance Sheet Data
|
(in
thousands)
|
|
|
December
31,
|
|
December
31,
|
2018
|
|
2017
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
332,371
|
|
$
172,379
|
Accounts receivable,
net
|
64,652
|
|
41,874
|
Total
assets
|
462,179
|
|
234,307
|
Promissory note
payable
|
-
|
|
25,000
|
Total stockholders'
equity
|
370,160
|
|
131,136
|
|
|
|
|
Investor Relations and Media Contact:
David Szekeres
Senior VP, General Counsel, Business Development and Corporate
Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.