SAN DIEGO, Feb. 24, 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 and twelve months ended December 31,
2020 and highlighted recent corporate updates.
Recent Corporate Updates
Pain Management 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 Prescription Drug User Fee
Act (PDUFA) goal date of May 12,
2021.
- European Commission Authorization for ZYNRELEF™ for the
Treatment of Postoperative Pain: In September 2020, the European Commission (EC)
granted a marketing authorization for ZYNRELEF (formerly known as
HTX-011) for the treatment of somatic postoperative pain from
small- to medium-sized surgical wounds in adults. As Heron builds
large-scale manufacturing capacity to meet the anticipated
commercial demand in the U.S. and the rest of the world, we are
developing a coordinated global marketing strategy. At this time,
Heron anticipates making ZYNRELEF available to patients in
Europe during 2022.
- Low-Dose HTX-034 Produced Greater Pain Reduction Compared to
Bupivacaine, the Current Standard-of-Care, Through 96 Hours in
Bunionectomy Study: In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled,
dose-escalation study in 33 patients undergoing bunionectomy, the
reduction in pain intensity observed was greater with the lowest
dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus
meloxicam and aprepitant) than with the bupivacaine 50 mg solution
through 96 hours.
-
- In addition, 45.5% of HTX-034 patients remained opioid-free
through Day 15 with median opioid consumption of 2.5 mg morphine
equivalents (same as one 5 mg oxycodone pill) through 72 hours, a
71% reduction compared to bupivacaine solution.
- Heron expects to initiate the expanded Phase 2 portion of the
study for HTX-034 in the first quarter of 2021.
CINV Franchise
- CINV 2020 Net Product Sales: For the three and
twelve months ended December 31,
2020, chemotherapy-induced nausea and vomiting (CINV)
franchise net product sales were $20.6 million and $88.6 million, respectively, compared to
$35.1 million and $146.0 million for the same periods in 2019.
-
- CINVANTI® Net Product
Sales: Net product sales of CINVANTI (aprepitant)
injectable emulsion for the three and twelve months ended
December 31, 2020 were $20.3 million and $87.8
million, respectively, compared to $34.6 million and $132.2
million, respectively, for the same periods in 2019. 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 and twelve months ended
December 31, 2020 were $0.3 million and $0.8
million, respectively, compared to $0.5 million and $13.8
million for the same periods in 2019. On October 1, 2019, we discontinued all discounting
of SUSTOL to improve the reimbursement and net selling price of the
product, which resulted in significantly lower SUSTOL net product
sales in 2020. Heron expects SUSTOL to return to growth in 2021 and
beyond.
- Full-Year 2021 Net Product Sales Guidance: Heron
expects full-year 2021 net product sales for the CINV franchise of
$130 million to $145 million.
HTX-019 for PONV
- HTX-019 Achieved Bioequivalence to Approved Oral Aprepitant
40 mg Dose for Prevention of PONV: A new Investigational
New Drug application for HTX-019 (aprepitant injectable emulsion)
for postoperative nausea and vomiting (PONV) was approved by the
FDA in late September of 2020. In the Phase 1 bioequivalence study,
32 mg of HTX-019 as a 30-second intravenous (IV) injection was
bioequivalent to oral aprepitant 40 mg, which is approved for the
prevention of PONV. An NDA for HTX-019 is planned in late 2021 for
prevention of PONV in adults.
Corporate Update
- Year-End 2020 Cash Balance: Heron ended 2020 with
$208.5 million in cash, cash
equivalents and short-term investments.
"We are very pleased that we exceeded our CINV sales guidance
for the year, despite 2020 being a challenging year for Heron,
with our CINV franchise impacted by both the COVID-19 global
pandemic and the EMEND® IV generic arbitrage. We
also achieved several important milestones in 2020, including
the authorization of ZYNRELEF in Europe and the advancement of HTX-034 for
postoperative pain and HTX-019 for PONV into clinical development,"
said Barry Quart, Pharm.D., Chairman and Chief Executive
Officer of Heron. "We believe that 2021 will be a
transformational year for Heron, with significant growth expected
in our CINV products with net product sales guidance
of $130 million to $145 million, the anticipated FDA
approval and commercial launch of HTX-011 in the U.S., and the
submission of an NDA for HTX-019 for PONV in the fourth
quarter."
Financial Results
Net product sales for the three and twelve months ended
December 31, 2020 were $20.6 million and $88.6
million, respectively, compared to $35.1 million and $146.0
million, respectively, for the same periods in 2019.
Heron's net loss for the three and twelve months ended
December 31, 2020 was $62.3 million and $227.3
million, or $0.68 per share
and $2.50 per share, respectively,
compared to $57.9 million and
$204.7 million, or $0.65 per share and $2.50 per share, respectively, for the same
periods in 2019. Net loss for the three and twelve months ended
December 31, 2020 included non-cash,
stock-based compensation expense of $16.0
million and $50.2 million,
respectively, compared to $11.1
million and $51.4 million,
respectively, for the same periods in 2019.
As of December 31, 2020, Heron had cash, cash equivalents
and short-term investments of $208.5 million compared to
$391.0 million as of December 31, 2019. Net cash used for operating
activities for the twelve months ended December 31, 2020 was $184.8 million, compared to $124.6 million for the same period in 2019. 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.
Heron is working to respond to a list of questions received
from Health Canada in July 2020. In September
2020, the EC 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. The EC's centralized marketing authorization is
valid for the 27 countries that are members of the European
Union, the other countries in the 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 Postoperative Nausea and Vomiting
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-HT3 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. 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: whether the FDA approves
the NDA for HTX-011; the timing of the commercial launch of HTX-011
in the U.S., if approved; the timing of the commercial launch
of ZYNRELEF in Europe; the timing of Health
Canada's New Drug Submission (NDS) review process for HTX-011;
whether Health Canada issues a Notice of Compliance for
the NDS for HTX-011; 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 CINV 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 Coronavirus
Disease 2019 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
|
|
Twelve Months
Ended
|
|
|
December 31,
|
|
December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
(Unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
20,605
|
|
$
35,083
|
|
$
88,638
|
|
$
145,968
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
9,392
|
|
15,874
|
|
36,189
|
|
61,619
|
Research and
development
|
|
44,453
|
|
48,277
|
|
174,533
|
|
167,382
|
General and
administrative
|
|
12,503
|
|
9,874
|
|
42,226
|
|
37,897
|
Sales and
marketing
|
|
15,553
|
|
20,420
|
|
63,853
|
|
89,764
|
Total operating
expenses
|
|
81,901
|
|
94,445
|
|
316,801
|
|
356,662
|
Loss from
operations
|
|
(61,296)
|
|
(59,362)
|
|
(228,163)
|
|
(210,694)
|
Other income
(expense), net
|
|
(985)
|
|
1,442
|
|
885
|
|
5,945
|
Net loss
|
|
$
(62,281)
|
|
$
(57,920)
|
|
$
(227,278)
|
|
$
(204,749)
|
Basic and diluted net
loss per share
|
|
$
(0.68)
|
|
$
(0.65)
|
|
$
(2.50)
|
|
$
(2.50)
|
Shares used in
computing basic and diluted net loss per share
|
|
91,081
|
|
89,112
|
|
90,774
|
|
81,779
|
Heron
Therapeutics, Inc.
|
Consolidated Balance
Sheets
|
(in
thousands)
|
|
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
105,138
|
|
$
71,898
|
Short-term
investments
|
|
103,353
|
|
319,074
|
Accounts receivable,
net
|
|
41,850
|
|
39,879
|
Inventory
|
|
41,905
|
|
24,968
|
Prepaid expenses and
other current assets
|
|
21,950
|
|
23,245
|
Total current
assets
|
|
314,196
|
|
479,064
|
Property and
equipment, net
|
|
22,737
|
|
19,618
|
Right-of-use lease
assets
|
|
16,277
|
|
13,754
|
Other
assets
|
|
346
|
|
346
|
Total
assets
|
|
$
353,556
|
|
$
512,782
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
525
|
|
$
2,758
|
Accrued clinical and
manufacturing liabilities
|
|
49,962
|
|
34,614
|
Accrued payroll and
employee liabilities
|
|
13,597
|
|
15,248
|
Other accrued
liabilities
|
|
28,369
|
|
36,535
|
Current lease
liabilities
|
|
2,997
|
|
1,926
|
Convertible notes
payable to related parties
|
|
7,053
|
|
5,624
|
Total current
liabilities
|
|
102,503
|
|
96,705
|
Non-current lease
liabilities
|
|
14,561
|
|
12,242
|
Total
liabilities
|
|
117,064
|
|
108,947
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Preferred
stock
|
|
—
|
|
—
|
Common
stock
|
|
913
|
|
903
|
Additional paid-in
capital
|
|
1,628,070
|
|
1,568,317
|
Accumulated other
comprehensive income
|
|
257
|
|
85
|
Accumulated
deficit
|
|
(1,392,748)
|
|
(1,165,470)
|
Total stockholders'
equity
|
|
236,492
|
|
403,835
|
Total liabilities and
stockholders' equity
|
|
$
353,556
|
|
$
512,782
|
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.