SAN DIEGO, Aug. 9, 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 six months ended June 30,
2021 and highlighted recent corporate updates.
Recent Corporate Updates
Acute Care Franchise
- ZYNRELEF Now Available: In May
2021, the U.S. Food and Drug Administration (FDA) approved
the Company's New Drug Application (NDA) for ZYNRELEF (bupivacaine
and meloxicam) extended-release solution. ZYNRELEF is indicated for
use in adults for soft tissue or periarticular instillation to
produce postsurgical analgesia for up to 72 hours after
bunionectomy, open inguinal herniorrhaphy and total knee
arthroplasty. ZYNRELEF became commercially available in the U.S. on
July 1, 2021. During the initial
weeks of commercial launch, the reception to ZYNRELEF has been
positive with 61 unique accounts already purchasing the product.
The Company has applied for a unique C-code for ZYNRELEF, which
would provide 3-year Medicare reimbursement outside the surgical
bundle payment for outpatient procedures. In the interim, Medicare
will reimburse ZYNRELEF under a miscellaneous C-code. In addition,
multiple payers covering over 86 million commercial and Medicaid
lives have already agreed to reimburse ZYNRELEF outside the
surgical bundle payment for surgeries performed in ambulatory
surgical centers, with many of these covered lives also having
their hospital outpatient procedures reimbursed outside the
surgical bundle payment.
- NDA for HTX-019 for Prevention of PONV in Adults Planned in
Late 2021: A 505(b)(2) NDA for HTX-019 for prevention of
postoperative nausea and vomiting (PONV) in adults is on track for
filing in late 2021.
Oncology Care Franchise
- 2021 Net Product Sales: For the three and six months
ended June 30, 2021, oncology care
franchise net product sales were $22.4
million and $42.5 million,
respectively, compared to $22.7
million and $48.1 million,
respectively, for the same periods in 2020. During the second
quarter of 2021, the net product sales increased by 12% compared to
the prior quarter and this increase was in-line with the 10% to 20%
growth anticipated for the quarter. Heron continues to expect
growth of the oncology care franchise net product sales, but at a
slower rate than originally projected. Key factors influencing our
growth rate projections are the lower rate of new cancer patient
treatment starts due to the COVID-19 pandemic, fewer clinic
anti-emetic administrations during the first half of 2021 compared
to the prior year, stronger than expected competition, and the
impact of value-based payer reimbursement.
-
- CINVANTI® Net Product Sales: Net
product sales of CINVANTI (aprepitant) injectable emulsion for the
three and six months ended June 30,
2021 were $19.7 million and
$38.2 million, respectively, compared
to $22.6 million and $47.8 million, respectively, for the same periods
in 2020. During the second quarter of 2021, CINVANTI demand units
increased by 22% over the prior quarter, which was partially offset
by a lower net selling price.
- SUSTOL® Net Product Sales: Net product
sales of SUSTOL (granisetron) extended-release injection for the
three and six months ended June 30,
2021 were $2.7 million and
$4.3 million, respectively, compared
to $0.1 million and $0.3 million, respectively, for the same periods
in 2020. During the second quarter of 2021, SUSTOL demand units
increased by 108% over the prior quarter, which was partially
offset by a lower net selling price.
- 2021 Oncology Care Franchise Net Product Sales Guidance:
Heron currently expects third quarter of 2021 net product sales for
the oncology care franchise to increase approximately 5% to 10%
compared to the prior quarter. The Company is withdrawing its
full-year 2021 net product sales guidance for the oncology care
franchise based on the uncertainty associated with the rate of new
cancer patient treatment starts and the impact of value-based
contracting reimbursement.
"The reception in the marketplace for ZYNRELEF has been
outstanding, with a large number of ordering accounts for the first
weeks of a launch. Another important accomplishment in these first
weeks of launch has been securing an unprecedented number of
commercial and Medicaid payers agreeing to reimburse ZYNRELEF
outside the surgical bundled payment. We are currently working with
the FDA to determine the requirements to expand the drug's label
for use in additional indications," said Barry Quart, Pharm.D.,
Chairman and Chief Executive Officer of Heron. "For the oncology
care franchise, our net product sales for the first half of 2021
were $42.5 million, and we expect
sales for CINVANTI and SUSTOL to continue to grow in the
second half of the year. In addition, we continue to advance
HTX-019 and remain on track to submit an NDA to the FDA for PONV
prevention in Q4 2021."
Financial Results
Net product sales for the three and six months ended
June 30, 2021 were $22.4 million and $42.5
million, respectively, compared to $22.7 million and $48.1 million, respectively, for the same periods
in 2020.
Heron's net loss for the three and six months ended June 30, 2021 was $61.0
million and $113.6 million, or
$0.62 per share and $1.20 per share, respectively, compared to
$55.2 million and $106.8 million, or $0.61 per share and $1.18 per share, respectively, for the same
periods in 2020. Net loss for the three and six months ended
June 30, 2021 included non-cash,
stock-based compensation expense of $11.2
million and $22.7 million,
respectively, compared to $11.1
million and $23.1 million,
respectively, for the same periods in 2020.
As of June 30, 2021, Heron had cash, cash equivalents and
short-term investments of $257.7 million, compared to
$208.5 million as of December 31, 2020. Net cash used for operating
activities for the six months ended June 30,
2021 was $104.9 million,
compared to $90.2 million for the
same period in 2020. The increase in our net cash used for
operating activities was primarily due to changes in working
capital to prepare for the launch of ZYNRELEF in July 2021, including manufacturing of commercial
inventory. We expect our net cash used for operating activities to
moderate later this year.
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic that
delivers a fixed-dose combination of the local anesthetic
bupivacaine and a low dose of nonsteroidal anti-inflammatory drug
meloxicam. ZYNRELEF is the first modified-release local anesthetic
to be classified by FDA as an "extended-release" product because
ZYNRELEF is also the first and only extended-release local
anesthetic to demonstrate in Phase 3 studies significantly reduced
pain and significantly increased proportion of patients requiring
no opioids through the first 72 hours following surgery
compared to bupivacaine solution, the current standard-of-care
local anesthetic for postoperative pain control. ZYNRELEF was
approved by the FDA in May 2021 for use in adults for
soft tissue or periarticular instillation to produce postsurgical
analgesia for up to 72 hours after bunionectomy, open inguinal
herniorrhaphy and total knee arthroplasty. Safety and efficacy have
not been established in highly vascular surgeries, such as
intrathoracic, large multilevel spinal, and head and neck
procedures. In September 2020, the European
Commission granted a marketing authorization for ZYNRELEF 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.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
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 for Chemotherapy Induced Nausea and Vomiting
(CINV) Prevention
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.
Please see full prescribing information
at www.CINVANTI.com.
About SUSTOL for CINV Prevention
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, the timing of the commercial launch of ZYNRELEF
in Europe; the potential market
opportunities for ZYNRELEF in the U.S. and Europe; the timing and results of studies for
the potential expansion of the U.S. label for ZYNRELEF and for the
HTX-019 development program; whether the FDA approves ZYNRELEF for
additional indications; the timing of the NDA filing and review
process for HTX-019; the 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
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
22,443
|
|
$
22,668
|
|
$
42,461
|
|
$
48,068
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
14,522
|
|
9,005
|
|
23,729
|
|
19,627
|
Research and
development
|
|
35,233
|
|
44,004
|
|
73,349
|
|
80,898
|
General and
administrative
|
|
10,907
|
|
9,819
|
|
20,480
|
|
20,241
|
Sales and
marketing
|
|
22,250
|
|
15,589
|
|
37,486
|
|
35,785
|
Total operating
expenses
|
|
82,912
|
|
78,417
|
|
155,044
|
|
156,551
|
Loss from
operations
|
|
(60,469)
|
|
(55,749)
|
|
(112,583)
|
|
(108,483)
|
Other income
(expense)
|
|
(546)
|
|
559
|
|
(1,046)
|
|
1,714
|
Net loss
|
|
$
(61,015)
|
|
$
(55,190)
|
|
$(113,629)
|
|
$(106,769)
|
Basic and diluted net
loss per share
|
|
$
(0.62)
|
|
$
(0.61)
|
|
$
(1.20)
|
|
$
(1.18)
|
Shares used in
computing basic and
diluted net loss per share
|
|
98,459
|
|
90,753
|
|
94,943
|
|
90,581
|
Heron
Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands)
|
|
|
|
June
30,
2021
|
|
December 31,
2020
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
191,173
|
|
$
105,138
|
Short-term
investments
|
|
66,505
|
|
103,353
|
Accounts receivable,
net
|
|
42,615
|
|
41,850
|
Inventory
|
|
42,800
|
|
41,905
|
Prepaid expenses and
other current assets
|
|
23,733
|
|
21,950
|
Total current
assets
|
|
366,826
|
|
314,196
|
Property and
equipment, net
|
|
22,175
|
|
22,737
|
Right-of-use lease
assets
|
|
14,903
|
|
16,277
|
Other
assets
|
|
346
|
|
346
|
Total
assets
|
|
$
404,250
|
|
$
353,556
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
11,242
|
|
$
525
|
Accrued clinical and
manufacturing liabilities
|
|
23,907
|
|
49,962
|
Accrued payroll and
employee liabilities
|
|
13,681
|
|
13,597
|
Other accrued
liabilities
|
|
30,151
|
|
28,369
|
Current lease
liabilities
|
|
3,162
|
|
2,997
|
Convertible notes
payable to related parties, net of discount
|
|
—
|
|
7,053
|
Total current
liabilities
|
|
82,143
|
|
102,503
|
Non-current lease
liabilities
|
|
13,013
|
|
14,561
|
Non-current
convertible notes payable, net
|
|
148,982
|
|
—
|
Total
liabilities
|
|
244,138
|
|
117,064
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
1,019
|
|
913
|
Additional paid-in
capital
|
|
1,665,429
|
|
1,628,070
|
Accumulated other
comprehensive income
|
|
41
|
|
257
|
Accumulated
deficit
|
|
(1,506,377)
|
|
(1,392,748)
|
Total stockholders'
equity
|
|
160,112
|
|
236,492
|
Total liabilities and
stockholders' equity
|
|
$
404,250
|
|
$
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.