SAN DIEGO, May 10, 2021 /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 months ended March 31, 2021 and
highlighted recent corporate updates.
Recent Corporate Updates
Acute Care Franchise
- New Drug Application Resubmission for HTX-011 Under
Review: The New Drug Application (NDA) resubmission for
HTX-011, an investigational agent for the management of
postoperative pain, submitted November 12,
2020 to the U.S. Food and Drug Administration (FDA),
continues under review. The FDA set a PDUFA goal date of
May 12, 2021.
- Initiation of Expanded Phase 2 Clinical Study of HTX-034 for
the Treatment of Postoperative Pain: In March 2021, Heron initiated the expanded Phase 2
clinical study in patients undergoing bunionectomy with HTX-034,
Heron's next-generation product for the treatment of postoperative
pain.
- NDA for HTX-019 Planned in Late 2021 for Prevention of PONV
in Adults: In the Phase 1 bioequivalence study, HTX-019 32 mg
as a 30-second intravenous (IV) injection was bioequivalent to oral
aprepitant 40 mg, which is approved for the prevention of
postoperative nausea and vomiting (PONV). A 505(b)(2) NDA for
HTX-019 for PONV in adults is planned for late 2021.
Oncology Care Franchise
- 2021 Net Product Sales: For the three months ended
March 31, 2021, oncology care
franchise net product sales were $20.0
million, compared to $25.4
million for the same period in 2020. The Coronavirus Disease
2019 (COVID-19) pandemic reduced cancer screening procedures and
new patient treatment starts in 2020 resulting in fewer clinic
anti-emetic administrations during the first quarter of 2021
compared to the prior year and last quarter. Heron is assisting
Community Oncology Alliance with its campaign to get patients back
into screening. With the greater availability of COVID-19 vaccines
and the declining rates of infection, Heron believes that the
number of patients receiving cancer treatment will begin to return
to normal levels.
-
- CINVANTI® Net Product Sales: Net
product sales of CINVANTI (aprepitant) injectable emulsion for the
three months ended March 31, 2021
were $18.5 million, compared to
$25.2 million for the same period in
2020. Based on recently signed agreements with key customers, Heron
believes the most significant impact of the generic arbitrage is
over and expects to grow CINVANTI market share in 2021 and
beyond.
- SUSTOL® Net Product Sales: Net product
sales of SUSTOL (granisetron) extended-release injection for the
three months ended March 31, 2021
were $1.5 million, compared to
$0.2 million for the same period in
2020. In the first quarter of 2021, Heron reinstated promotion and
contracting of SUSTOL to restore growth in 2021 and beyond.
- Full-Year 2021 Net Product Sales Guidance: Heron expects
full-year 2021 net product sales for the oncology care franchise of
$130 million to $145 million.
"We have no outstanding questions on the pending NDA and are
currently in labelling discussions with the FDA, as we prepare for
the anticipated commercial launch of HTX-011 in the U.S.,"
said Barry Quart, Pharm.D., Chairman and Chief Executive
Officer of Heron. "For the oncology care franchise, we
expect the market to pick up in the second quarter and we recently
signed a large, multi-year contract for CINVANTI that will help
increase net product sales throughout 2021."
Financial Results
Net product sales for the three months ended March 31, 2021 were $20.0
million, compared to $25.4 million for the same period in
2020.
Heron's net loss for the three months ended March 31, 2021 was $52.6
million, or $0.58 per share,
compared to $51.6 million, or
$0.57 per share for the same period
in 2020. Net loss for the three months ended March 31, 2021 included non-cash, stock-based
compensation expense of $11.5
million, compared to $12.0
million for the same period in 2020.
As of March 31, 2021, Heron had cash, cash equivalents and
short-term investments of $166.5 million, compared to
$208.5 million as of December 31, 2020. Net cash used for operating
activities for the three months ended March
31, 2021 was $41.9 million,
compared to $32.9 million for the
same period in 2020. Heron expects that its current cash, cash
equivalents and short-term investments will be sufficient to fund
its operations into 2022.
About HTX-011 for Postoperative Pain (ZYNRELEF™ in
Europe)
HTX-011, an investigational non-opioid analgesic, 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. The FDA granted Breakthrough
Therapy designation to HTX-011 and the NDA received Priority Review
designation. A complete response letter was received from the FDA
regarding the NDA for HTX-011 in June 2020 relating to
non-clinical information. No clinical safety or efficacy issues and
no chemistry, manufacturing and controls issues were identified.
Heron resubmitted an NDA to the FDA for HTX-011 in November
2020 and the FDA set a PDUFA goal date of May 12, 2021.
In September 2020, the European Commission granted a
marketing authorization for ZYNRELEF (also known as HTX-011) for
the treatment of somatic postoperative pain from small- to
medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31
European countries including the countries of the European Union
and European Economic Area and the United Kingdom.
About HTX-034 for Postoperative Pain
HTX-034, an investigational non-opioid analgesic, is a
triple-acting, fixed-dose combination of the local anesthetic
bupivacaine with a low dose of the nonsteroidal anti-inflammatory
drug meloxicam and aprepitant, an additional agent that further
potentiates the activity of bupivacaine. HTX-034 is formulated in
the same proprietary polymer as HTX-011. By combining two different
mechanisms that each enhance the activity of the local anesthetic
bupivacaine, HTX-034 is designed to provide superior and prolonged
analgesia. Local administration of HTX-034 in a validated
preclinical postoperative pain model resulted in sustained
analgesia for 7 days.
About HTX-019 for PONV
HTX-019 is an IV injectable emulsion formulation designed to
directly deliver aprepitant, the active ingredient in
EMEND® (aprepitant) capsules, which is the only
substance P/neurokinin-1 (NK1) receptor antagonist (RA)
to be approved in the U.S. for the prevention of PONV in
adults. The FDA-approved dose of oral EMEND is 40 mg for PONV,
which is given within 3 hours prior to induction of
anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of
HTX-019 as a 30-second IV injection was demonstrated to be
bioequivalent to oral aprepitant 40 mg.
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
as a single-dose regimen, delayed nausea and vomiting associated
with initial and repeat courses of moderately emetogenic cancer
chemotherapy (MEC) as a single-dose regimen, and nausea and
vomiting associated with initial and repeat courses of MEC as a
3-day regimen. 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 U.S. prescribing information for CINVANTI
is a 30-minute IV infusion or a 2-minute IV injection.
CINVANTI is under investigation for the treatment of
COVID-19 as a daily 2-minute IV injection when added to the current
standard of care.
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-hydroxytryptamine type 3 RA 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. Our advanced science,
patented technologies, and innovative approach to drug
discovery and development have allowed us to create and
commercialize a portfolio of products that aim to advance the
standard of care for acute care and oncology patients. 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: whether the FDA approves
the NDA for HTX-011; whether the scope of the label for HTX-011, if
approved, will be as desired; the timing of the commercial launch
of HTX-011 in the U.S., if approved; the timing and results of
studies for the HTX-034 and HTX-019 development programs; the
full-year 2021 net product sales guidance for the oncology care
franchise; 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; the extent of the impact of the
ongoing COVID-19 pandemic on our business; 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.
|
Consolidated
Statements of Operations
|
(In thousands, except
per share amounts)
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
(Unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
20,018
|
|
|
$
|
25,400
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
|
9,207
|
|
|
|
10,622
|
|
Research and
development
|
|
|
38,116
|
|
|
|
36,894
|
|
General and
administrative
|
|
|
9,573
|
|
|
|
10,422
|
|
Sales and
marketing
|
|
|
15,236
|
|
|
|
20,196
|
|
Total operating
expenses
|
|
|
72,132
|
|
|
|
78,134
|
|
Loss from
operations
|
|
|
(52,114)
|
|
|
|
(52,734)
|
|
Other income
(expense)
|
|
|
(500)
|
|
|
|
1,155
|
|
Net loss
|
|
$
|
(52,614)
|
|
|
$
|
(51,579)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.58)
|
|
|
$
|
(0.57)
|
|
Shares used in
computing basic and diluted net
loss per
share
|
|
|
91,388
|
|
|
|
90,409
|
|
Heron
Therapeutics, Inc.
|
Consolidated Balance
Sheets
|
(in
thousands)
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
59,739
|
|
$
105,138
|
Short-term
investments
|
|
106,727
|
|
103,353
|
Accounts receivable,
net
|
|
38,525
|
|
41,850
|
Inventory
|
|
42,629
|
|
41,905
|
Prepaid expenses and
other current assets
|
|
24,668
|
|
21,950
|
Total current
assets
|
|
272,288
|
|
314,196
|
Property and
equipment, net
|
|
22,704
|
|
22,737
|
Right-of-use lease
assets
|
|
15,594
|
|
16,277
|
Other
assets
|
|
346
|
|
346
|
Total
assets
|
|
$
310,932
|
|
$
353,556
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,689
|
|
$
525
|
Accrued clinical and
manufacturing liabilities
|
|
54,219
|
|
49,962
|
Accrued payroll and
employee liabilities
|
|
9,629
|
|
13,597
|
Other accrued
liabilities
|
|
24,744
|
|
28,369
|
Current lease
liabilities
|
|
3,081
|
|
2,997
|
Convertible notes
payable to related parties
|
|
7,555
|
|
7,053
|
Total current
liabilities
|
|
100,917
|
|
102,503
|
Non-current lease
liabilities
|
|
13,790
|
|
14,561
|
Total
liabilities
|
|
114,707
|
|
117,064
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
914
|
|
913
|
Additional paid-in
capital
|
|
1,640,552
|
|
1,628,070
|
Accumulated other
comprehensive income
|
|
121
|
|
257
|
Accumulated
deficit
|
|
(1,445,362)
|
|
(1,392,748)
|
Total stockholders'
equity
|
|
196,225
|
|
236,492
|
Total liabilities and
stockholders' equity
|
|
$
310,932
|
|
$
353,556
|
Investor Relations and Media Contact:
David Szekeres
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.