SAN DIEGO, Nov. 12, 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 announced financial results for the
three and nine months ended September 30,
2019 and highlighted recent corporate updates.
Recent Corporate Updates
Pain Management Franchise
- FDA Acceptance of New Drug Application Resubmission for
HTX-011: In October 2019, the
U.S. Food and Drug Administration (FDA) accepted Heron's New Drug
Application (NDA) resubmission for HTX-011, an investigational
agent for the management of postoperative pain. The FDA set a
Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020.
- Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee
Arthroplasty: In October
2019, Heron reported positive topline results of a
multi-center postoperative pain management study in which 51
patients undergoing total knee arthroplasty (TKA) surgery received
HTX-011 together with a scheduled postoperative regimen of generic
oral analgesics (acetaminophen and celecoxib). In this study, 75%
of patients were discharged from the hospital without a
prescription for opioids.
CINV Franchise
- CINV 2019 Net Product Sales: For the three months
ended September 30, 2019,
chemotherapy-induced nausea and vomiting (CINV) franchise net
product sales were $42.6 million, up
115% from the same period in 2018, and up 16% from the three months
ended June 30, 2019. For the nine
months ended September 30, 2019, CINV
franchise net product sales were $110.9
million, up 128% from the same period in 2018. Heron is
raising its full-year 2019 CINV franchise net product sales
guidance from $115–120 million to $135
million.
-
- CINVANTI Net Product Sales: Net product sales of
CINVANTI (aprepitant) injectable emulsion for the three and nine
months ended September 30, 2019 were
$36.4 million and $97.6 million, respectively, compared to
$16.4 million and $32.8 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 nine months ended
September 30, 2019 were $6.2 million and $13.3
million, respectively, compared to $3.4 million and $15.8
million for the same periods in 2018.
- FDA Approval of Supplemental NDA for CINVANTI: In
October 2019, the FDA approved
Heron's supplemental New Drug Application (sNDA) for CINVANTI
(aprepitant) injectable emulsion for intravenous (IV) use. The sNDA
approval resulted in a CINVANTI label expansion that standardizes
the CINVANTI 130 mg single-dose regimen for patients receiving HEC
and/or MEC as an injection over 2 minutes or an infusion over 30
minutes, further simplifying dosing and administration and
eliminating the need to take oral aprepitant on Days 2 and 3 in
patients receiving MEC.
"We are pleased with the advances made during the third quarter
of 2019 in both our pain management and CINV franchises,
highlighted by the FDA acceptance of our recent NDA resubmission
for HTX-011 and strong net product sales for our CINV franchise,
even amid the launch of generic fosaprepitant," said Barry Quart,
Pharm.D., President and Chief Executive Officer of Heron
Therapeutics. "We look forward to continuing our commercial
momentum with the launch of HTX-011 for postoperative pain
management in the second quarter of 2020, pending FDA
approval."
Financial Results
Net product sales for the three and nine months ended
September 30, 2019 were $42.6 million and $110.9
million, respectively, compared to $19.8 million and $48.6
million, respectively, for the same periods in 2018.
Heron's net loss for the three and nine months ended
September 30, 2019 was $33.6 million and $146.8
million, or $0.42 per share
and $1.85 per share, respectively,
compared to $38.3 million and
$129.3 million, or $0.49 per share and $1.81 per share, respectively, for the same
periods in 2018. Net loss for the three and nine months ended
September 30, 2019 included non-cash,
stock-based compensation expense of $9.7
million and $40.3 million,
respectively, compared to $8.1
million and $23.6 million,
respectively, for the same periods in 2018.
As of September 30, 2019, Heron had cash, cash equivalents
and short-term investments of $256.3 million. Adjusting for
net proceeds of $162.2 million from
our October 2019 public offering of
common stock, Heron had pro-forma cash, cash equivalents and
short-term investments of $418.5
million. This compares to $332.4 million in cash,
cash equivalents and short-term investments as of December 31,
2018. Net cash used for operating activities for the nine months
ended September 30, 2019 was
$97.6 million, compared to
$158.3 million for the same period in
2018.
About HTX-011 for Postoperative Pain
HTX-011, an investigational agent, is a dual-acting, fixed-dose
combination of the local anesthetic bupivacaine with a low dose of
the nonsteroidal anti-inflammatory drug meloxicam. It is the
first and only extended-release local anesthetic to demonstrate in
Phase 3 studies significantly reduced pain and opioid use through
72 hours compared to bupivacaine solution, the current
standard-of-care local anesthetic for postoperative pain control.
HTX-011 was granted Fast Track designation from the U.S. Food and
Drug Administration (FDA) in the fourth quarter of 2017 and
Breakthrough Therapy designation in the second quarter of 2018.
Heron submitted a New Drug Application (NDA) to the FDA for HTX-011
in October of 2018 and received Priority Review designation in
December of 2018. A Complete Response Letter (CRL) was received
from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry,
manufacturing and controls and non-clinical information. No issues
related to clinical efficacy or safety were noted. Heron
resubmitted an NDA to the FDA for HTX-011 in September 2019, and the FDA set a PDUFA goal date
of March 26, 2020. A Marketing
Authorisation Application (MAA) for HTX-011 was validated by the
European Medicines Agency (EMA) in March
2019 for review under the Centralised Procedure.
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 HEC,
including high-dose cisplatin, and nausea and vomiting associated
with initial and repeat courses of MEC. CINVANTI is an IV
formulation of aprepitant, an NK1 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). The FDA-approved dosing administration
included in the United States prescribing information for
CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.
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
product sales guidance for the CINV franchise; whether the FDA
approves the NDA for HTX-011; the timing of the commercial launch
of HTX-011; the timing of the CHMP's review process for HTX-011;
whether the European Commission authorizes the MAA for HTX-011; the
expected future balances of Heron's cash, cash equivalents and
short-term investments; the expected duration over which Heron's
cash, cash equivalents and short-term investments balances will
fund its operations; 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)
(unaudited)
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Net
product sales
|
$
42,624
|
|
$
19,786
|
|
$
110,885
|
|
$
48,630
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
product sales
|
17,195
|
|
7,576
|
|
45,745
|
|
15,940
|
Research
and development
|
34,708
|
|
30,421
|
|
119,105
|
|
100,141
|
General
and administrative
|
8,597
|
|
7,288
|
|
28,023
|
|
20,525
|
Sales
and marketing
|
16,977
|
|
16,281
|
|
69,344
|
|
44,647
|
Total operating
expenses
|
77,477
|
|
61,566
|
|
262,217
|
|
181,253
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(34,853)
|
|
(41,780)
|
|
(151,332)
|
|
(132,623)
|
|
|
|
|
|
|
|
|
Other income,
net
|
1,258
|
|
3,434
|
|
4,503
|
|
3,342
|
|
|
|
|
|
|
|
|
Net loss
|
$
(33,595)
|
|
$
(38,346)
|
|
$
(146,829)
|
|
$
(129,281)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.42)
|
|
$
(0.49)
|
|
$
(1.85)
|
|
$
(1.81)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and
diluted net loss per share
|
79,940
|
|
77,811
|
|
79,308
|
|
71,544
|
HERON
THERAPEUTICS, INC.
Condensed
Consolidated Balance Sheet Data
(in
thousands)
|
|
|
September
30,
|
|
December
31,
|
2019
|
|
2018
|
|
(unaudited)
|
|
|
Cash, cash
equivalents and short-term investments
|
$
256,278
|
|
$
332,371
|
Accounts receivable,
net
|
66,955
|
|
64,652
|
Total
assets
|
392,962
|
|
462,179
|
Total stockholders'
equity
|
285,442
|
|
370,160
|
|
|
|
|
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.