SAN DIEGO, Aug. 5, 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 six months ended June 30,
2019 and highlighted recent corporate updates.
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) on April 30, 2019 regarding the Company's New Drug
Application (NDA) for HTX-011 for postoperative pain management.
The CRL stated that the FDA 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, the FDA 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 ended March 31, 2019. For the six months ended
June 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 FDA shortly to discuss our responses
to the CRL for HTX-011, and we remain focused on resubmitting the
NDA as soon as possible," said Barry Quart, Pharm.D., President and
Chief Executive Officer of Heron. "Our CINV franchise continues to
perform well, highlighted by strong net product sales in the second
quarter."
Financial Results
Net product sales for the three and six months ended
June 30, 2019 were $36.7 million and $68.3
million, respectively, compared to $17.3 million and $28.8
million, respectively, for the same periods in 2018.
Heron's net loss for the three and six months ended June 30, 2019 was $50.2
million and $113.2 million, or
$0.63 per share and $1.43 per share, respectively, compared to
$38.7 million and $90.9 million, or $0.54 per share and $1.33 per share, respectively, for the same
periods in 2018. Net loss for the three and six months ended
June 30, 2019 included non-cash,
stock-based compensation expense of $12.7
million and $30.6 million,
respectively, compared to $7.8
million and $15.5 million,
respectively, for the same periods in 2018.
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
June 30, 2019 was $72.1 million compared to $122.4 million for the same period in 2018. Heron
expects to end the year with more than $190
million in cash, cash equivalents and short-term
investments.
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 FDA
regarding the NDA for HTX-011 on April 30,
2019 relating to CMC and non-clinical information. No issues
related to clinical efficacy or safety were noted. An MAA for
HTX-011 was validated by the 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 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
FDA-approved dosing administration included in the United States prescribing information for
CINVANTI is a 30-minute infusion or a 2-minute 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)
|
|
|
Three Months
Ended June
30,
|
|
Six Months
Ended June
30,
|
|
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.
|
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:
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.