· Net Product Sales for First Quarter of
2023 Grew 26% to $29.6 million,
Compared to First Quarter Net Product Sales in 2022
· Appointment of Craig Collard as Chief Executive Officer (CEO)
and Jason Grillot as Vice President
(VP), Sales and Marketing, of the Acute Care Franchise.
SAN
DIEGO, May 11, 2023 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) (the "Company"), a
commercial-stage biotechnology company focused on improving the
lives of patients by developing and commercializing therapeutic
innovations that improve medical care, today announced financial
results for the three months ended March 31,
2023 and highlighted recent corporate updates.
First quarter 2023 net product sales grew 26% to $29.6 million, compared to the first quarter of
2022. The sales growth was mainly driven by our oncology care
franchise, which increased 15%, compared to the same period in
2022. First quarter also reflected continued advancement of our
acute care franchise, with $3.5
million in net product sales from
ZYNRELEF® and initial orders from the launch of
APONVIE® in March.
With the appointment of Craig
Collard as CEO in April and the recent hiring of
Jason Grillot as VP of sales and
marketing of the acute care franchise, the team is conducting a
thorough review of the Company's business practices and strategies
to develop a long-term plan that maximizes the potential of the
Company. We have identified two areas of immediate priority for our
commercial team: first, is to enhance the value of ZYNRELEF through
a broader and deeper penetration of accounts; second, to address
application issues through training and expanded indications.
Further, we are looking at ways to reduce cash burn through
improved operational efficiency. We look forward to updating
investors on these fronts in the coming months.
Acute Care Franchise
- ZYNRELEF:
-
- Net product sales of ZYNRELEF (bupivacaine and meloxicam)
extended-release solution for the three months ended March 31, 2023 was $3.5 million.
- Since launch on July 1, 2021
through March 31, 2023, 907 unique
accounts purchased ZYNRELEF with 80% of those accounts reordering
the product.
- The supplemental New Drug Application (sNDA) for ZYNRELEF, to
support expanded use in soft tissue and orthopedic surgical
procedures remains on track for the Prescription Drug User Fee Act
(PDUFA) approval goal date of October 23,
2023.
- APONVIE:
-
- The APONVIE (aprepitant) injectable emulsion, the only
intravenous (IV) substance P/neurokinin-1 (NK1) receptor
antagonist (RA) indicated for the prevention of postoperative
nausea and vomiting (PONV) in adults, launched commercially in the
U.S. on March 6, 2023.
- Net product sales of APONVIE for the three months ended
March 31, 2023 were $0.3 million.
- The Centers for Medicare and Medicaid Services granted
pass-through payment status for APONVIE, effective April 1, 2023, under C-code C9145.
Oncology Care Franchise
- Oncology Care Franchise Net Product Sales: For the
three months ended March 31, 2023,
oncology care franchise net product sales were $25.8 million, which increased 15% from
$22.4 million for the same period in
2022.
- CINVANTI® Net Product
Sales: Net product sales of CINVANTI (aprepitant)
injectable emulsion for the three months ended March 31, 2023 were $22.8
million, compared to $20.3
million for the same period in 2022.
- SUSTOL® Net Product Sales: Net
product sales of SUSTOL (granisetron) extended-release injection
for the three months ended March 31,
2023 were $3.0 million,
compared to $2.1 million for the same
period in 2022.
"We continued to make steady progress in the first quarter of
2023 at Heron, highlighted by the approval and launch of our fourth
commercial product, APONVIE. We are pleased with the steady growth
in the oncology care franchise and remain encouraged by the market
potential for ZYNRELEF and APONVIE," said Craig Collard, new Chief Executive Officer of
Heron. "Looking ahead, we are focused on reducing our cash burn and
advancing a streamlined organization that we believe will begin to
show significant growth while also continuing to improve patient's
lives."
Financial Results
Net product sales for the three months ended March 31, 2023 were $29.6
million, compared to $23.5
million for the same period in 2022.
For the three months ended March 31,
2023, total operating expenses were $62.7 million,
compared to $86.4 million for the
same period in 2022, representing a decrease of $23.7 million,
or a 27% reduction year-over-year. This decrease was driven by cost
management efforts and a reduction in development projects, offset
by higher cost of goods sold and increased litigation expenses.
Cost of product sales were $16.9
million in the first quarter of 2023, compared to
$11.4 million for the same period in
the prior year. The product gross margin rate decreased
year-over-year primarily as a result of a one time inventory
write-off due to short-dated product. Sales and marketing expenses
decreased by $2.3
million, primarily due to a reduction in personnel
expenses and external costs to support the ongoing
commercialization of ZYNRELEF. Research and development expenses
decreased by $28.3
million, primarily driven by lower personnel and
project-related expenses, including manufacturing projects to
increase operational efficiencies. General and administrative
expenses increased by $1.3
million, primarily driven by increased litigation and
activist shareholder issues.
Heron's net loss for the three months ended March 31, 2023 was $32.8
million, or $0.27 per share,
compared to $63.9 million, or
$0.63 per share, for the same period
in 2022. Net loss for the three months ended March 31, 2023 included non-cash, stock-based
compensation expense of $7.9 million,
compared to $10.9 million for the
same period in 2022.
As of March 31, 2023, Heron had cash, cash equivalents and
short-term investments of $60.0 million, compared to
$84.9 million as of December 31, 2022. Net cash used for operating
activities for the three months ended March
31, 2023 was $24.9 million,
compared to $43.9 million for the
same period in 2022. The decrease in our net cash used for
operating activities was primarily due to a decrease in net loss,
the reduction in headcount implemented in June 2022 and changes in working capital.
Conference Call and Webcast
Heron will host a conference call and webcast on May 11, 2023 at 4:30 p.m.
ET. The conference call can be accessed by dialing (646)
307-1963 for domestic callers and (800) 715-9871 for international
callers. Please provide the operator with the passcode 1933547 to
join the conference call. The conference call will also be
available via webcast under the Investor Relations section of
Heron's website at www.herontx.com. An archive of the
teleconference and webcast will also be made available on Heron's
website for 60 days following the call.
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 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
initially 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. In December 2021, the FDA approved an expansion of
ZYNRELEF's indication. In December
2022, we submitted an sNDA to support the proposed
indication for greatly expanded use of ZYNRELEF in soft tissue and
orthopedic surgical procedures, and the FDA assigned a PDUFA goal
date of October 23, 2023. ZYNRELEF is
now indicated in the U.S. in adults for soft tissue or
periarticular instillation to produce postsurgical analgesia for up
to 72 hours after foot and ankle, small-to-medium open abdominal,
and lower extremity total joint arthroplasty surgical procedures.
Safety and efficacy have not been established in highly vascular
surgeries, such as intrathoracic, large multilevel spinal, and head
and neck procedures.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
About APONVIE for PONV
APONVIE is a substance NK1 RA, indicated for the
prevention of PONV in adults. Delivered via a 30-second IV push,
APONVIE 32 mg was demonstrated to be bioequivalent to oral
aprepitant 40 mg with rapid achievement of therapeutic drug levels.
APONVIE is the same formulation as Heron's approved drug product
CINVANTI. APONVIE is supplied in a single-dose vial that delivers
the full 32 mg dose for PONV. APONVIE was approved by the FDA in
September 2022.
Please see full prescribing information at www.APONVIE.com.
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
include 100 mg or 130 mg administered as 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 and commercializing therapeutic innovations that improve
medical care. 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, uncertainties related to market conditions; the
potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and
SUSTOL; the net product sales guidance for the oncology care
franchise and the acute care franchise; the results of the
commercial launch of APONVIE; the timing of the FDA's review
process and whether the FDA approves the sNDA for ZYNRELEF to
further expand the U.S. label; the potential additional market
opportunity for the expanded U.S. label, if approved; 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 ability for the Company to reach profitability; 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,
|
|
|
2023
|
|
2022
|
Revenues:
|
|
(unaudited)
|
Net product
sales
|
|
$
29,615
|
|
$
23,457
|
Operating
expenses:
|
|
|
|
|
Cost of product
sales
|
|
16,854
|
|
11,355
|
Research and
development
|
|
13,817
|
|
42,070
|
General and
administrative
|
|
10,853
|
|
9,533
|
Sales and
marketing
|
|
21,154
|
|
23,422
|
Total operating
expenses
|
|
62,678
|
|
86,380
|
Loss from
operations
|
|
(33,063)
|
|
(62,923)
|
Other income
(expense)
|
|
295
|
|
(965)
|
Net loss
|
|
$
(32,768)
|
|
$
(63,888)
|
Heron Therapeutics,
Inc.
Consolidated Balance
Sheets
(in
thousands)
|
|
|
|
March 31,
2023
|
|
December 31,
2022
|
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
27,090
|
|
$
15,364
|
Short-term
investments
|
|
32,932
|
|
69,488
|
Accounts receivable,
net
|
|
51,448
|
|
52,049
|
Inventory
|
|
52,059
|
|
54,573
|
Prepaid expenses and
other current assets
|
|
14,630
|
|
13,961
|
Total current
assets
|
|
178,159
|
|
205,435
|
Property and equipment,
net
|
|
21,512
|
|
22,160
|
Right-of-use lease
assets
|
|
7,071
|
|
7,645
|
Other assets
|
|
14,136
|
|
15,711
|
Total
assets
|
|
$
220,878
|
|
$
250,951
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
4,065
|
|
$
3,225
|
Accrued clinical and
manufacturing liabilities
|
|
21,273
|
|
24,468
|
Accrued payroll and
employee liabilities
|
|
9,510
|
|
13,416
|
Other accrued
liabilities
|
|
40,290
|
|
38,552
|
Current lease
liabilities
|
|
2,762
|
|
2,694
|
Total current
liabilities
|
|
77,900
|
|
82,355
|
Non-current lease
liabilities
|
|
4,831
|
|
5,499
|
Non-current
convertible notes payable, net
|
|
149,335
|
|
149,284
|
Other non-current
liabilities
|
|
241
|
|
241
|
Total
liabilities
|
|
232,307
|
|
237,379
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
|
1,193
|
|
1,191
|
Additional paid-in
capital
|
|
1,815,592
|
|
1,807,855
|
Accumulated other
comprehensive income (loss)
|
|
9
|
|
(19)
|
Accumulated
deficit
|
|
(1,828,223)
|
|
(1,795,455)
|
Total stockholders'
equity (deficit)
|
|
(11,429)
|
|
13,572
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
220,878
|
|
$
250,951
|
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.