- Company is well capitalized after signing $50 million working capital credit facility and
recent $30 million equity
raise
- Favorable outcome at Markman hearing in pending
CINVANTI® ANDA patent litigation
- New management team in place
- Reiterating full-year net product sales guidance for the
oncology care franchise of $99-$103
million
SAN
DIEGO, Aug. 14, 2023 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or 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 and six months ended June 30, 2023 and highlighted recent corporate
updates.
"During the second quarter of 2023, the new executive management
team has been focused on resizing the business and recently
announced a cost reduction program that is anticipated to save the
Company approximately $75 million in
cash spend through 2025," said Craig
Collard, Chief Executive Officer of Heron. "We are in the
early stages of revamping Heron into a commercially focused company
with efficient operations. As we move through the remainder of
2023, our team is focused on commercial execution and we look
forward to updating you on those efforts in the near-term. In
addition to the cost-cutting, we were able to bolster the balance
sheet by completing a $30 million
equity financing with some of our largest shareholders, as well as
closing on a $50 million working
capital facility. Based on our current operational plan, we expect
that this will provide the Company with enough capital to achieve
profitability."
Recent Corporate Updates
- Financings:
-
- In July 2023, Heron completed a
private placement equity financing with estimated net proceeds from
the sale of Company common stock and pre-funded warrants of
$29.7 million.
- In August 2023, Heron entered
into a working capital facility, providing for an aggregate gross
principal amount of up to $50.0
million in working capital for the Company, subject to
certain terms and conditions, with approximately $24.5 million in net proceeds drawn at
closing.
Acute Care Franchise
- Acute Care Franchise Net Product Sales: For the three
and six months ended June 30, 2023,
acute care franchise net product sales were $4.5 million and $8.3
million, respectively, which increased from $2.5 million and $3.5
million, respectively, for the same periods in 2022.
- ZYNRELEF® Net Product Sales and
PDUFA Update:
-
- Net product sales of ZYNRELEF (bupivacaine and meloxicam)
extended-release solution for the three and six months ended
June 30, 2023 were $4.2 million and $7.7
million, respectively, which increased from $2.5 million and $3.5
million, respectively, for the same periods in 2022.
- On July 31, 2023, Heron was
notified by the U.S. Food and Drug Administration (FDA) that the
Prescription Drug User Fee Act (PDUFA) approval goal date for the
supplemental New Drug Application (sNDA) for ZYNRELEF was extended
by three months to provide for a full review of the submission. The
FDA has set a new extended PDUFA approval goal date of January 23, 2024.
- APONVIE® Net Product
Sales:
-
- Net product sales of APONVIE for the three and six months
ended June 30, 2023 were $0.3 million and $0.6
million, respectively, with no sales in the comparable prior
year periods. APONVIE became commercially available in the U.S. on
March 6, 2023.
Oncology Care Franchise
- Oncology Care Franchise Net Product Sales: For the three
and six months ended June 30, 2023,
oncology care franchise net product sales were $27.3 million and $53.1
million, respectively, which increased from $25.1 million and $47.5
million, respectively, for the same periods in 2022.
- CINVANTI Net Product Sales: Net product
sales of CINVANTI (aprepitant) injectable emulsion for the three
and six months ended June 30, 2023
were $24.5 million and $47.3 million, respectively, which increased from
$22.7 million and $43.0 million, respectively, for the same periods
in 2022.
- CINVANTI ANDA Litigation: Heron recently had a favorable
outcome at the Markman hearing in the pending Hatch-Waxman
Abbreviated New Drug Application litigation against Fresenius Kabi
to enforce our CINVANTI patents. We are pleased with the outcome
and will continue to vigorously enforce and defend our patent
portfolio.
- SUSTOL® Net Product Sales: Net product
sales of SUSTOL (granisetron) extended-release injection for the
three and six months ended June 30,
2023 were $2.8 million
and $5.8 million, respectively, which
increased from $2.4 million and
$4.5 million, respectively, for the
same periods in 2022.
- 2023 Oncology Care Franchise Net Product Sales
Guidance: Heron is reiterating full-year 2023 net product
sales guidance for the oncology care franchise of $99 million to $103
million.
The Company also recently granted equity awards to four new
employees, with grant dates ranging from July 31 through August 14, 2023, as equity
inducement awards outside of the Company's Amended and Restated
2007 Equity Incentive Plan. The employees received, in the
aggregate, options to purchase up to 710,000 shares of the
Company's common stock. The options subject to each respective
award have an exercise price equal to the closing price per share
of the Company's common stock as reported on the Nasdaq Capital
Market on each employee's respective employment start date. The
options subject to these awards each have a 10-year term with a
four-year vesting schedule, with 25% of the shares subject to the
option vesting on the first anniversary of the grant date and the
remaining 75% vesting on a monthly basis over the next three years,
subject to each respective employee's continuous service through
each vesting date. In accordance with Nasdaq Listing Rule
5635(c)(4), the inducement award grants were approved by Heron's
Compensation Committee of the Board of Directors and made as a
material inducement to each employee entering into employment with
the Company.
Conference Call and Webcast
Heron will host a conference call and webcast on August 14, 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 5410567 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. On July 31,
2023, the FDA notified Heron of an extension of the PDUFA
approval goal date by three months to provide for a full review of
the submission. The FDA has set a new extended PDUFA approval goal
date of January 23, 2024. 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. ZYNRELEF was granted a marketing authorization
by the European Commission in September
2020 and by the United Kingdom Regulatory Authority in
January 2021. In August 2023, we cancelled the U.K. marketing
authorization for ZYNRELEF, as we do not plan to commercially
launch ZYNRELEF in the U.K. As of August 2,
2023, ZYNRELEF is approved in 30 European countries
including the countries of the European Union and the European
Economic Area. ZYNRELEF is indicated in Europe for the treatment of somatic
postoperative pain from small- to medium-sized surgical wounds in
adults.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
About APONVIE for Postoperative Nausea and Vomiting
(PONV)
APONVIE is a substance NK1 Receptor Antagonist (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 and became commercially available in the U.S. on
March 6, 2023.
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 for ZYNRELEF, 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 and the risk that future equity financings may
be needed; failure to realize the expected benefits from the cost
reduction plan and restructuring; any inability or delay in
achieving 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
31,762
|
|
$ 27,630
|
|
$ 61,377
|
|
$
51,087
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
20,158
|
|
16,175
|
|
37,012
|
|
27,530
|
Research and
development
|
|
17,572
|
|
28,834
|
|
31,389
|
|
70,904
|
General and
administrative
|
|
15,230
|
|
9,181
|
|
26,083
|
|
18,714
|
Sales and
marketing
|
|
21,205
|
|
22,938
|
|
42,359
|
|
46,360
|
Total operating
expenses
|
|
74,165
|
|
77,128
|
|
136,843
|
|
163,508
|
Loss from
operations
|
|
(42,403)
|
|
(49,498)
|
|
(75,466)
|
|
(112,421)
|
Other income
(expense), net
|
|
344
|
|
(6,861)
|
|
639
|
|
(7,826)
|
Net loss
|
|
$(42,059)
|
|
$(56,359)
|
|
$(74,827)
|
|
$(120,247)
|
Basic and diluted net
loss per share
|
|
$
(0.35)
|
|
$
(0.55)
|
|
$
(0.63)
|
|
$ (1.18)
|
Weighted average common
shares outstanding, basic and diluted
|
|
119,719
|
|
102,405
|
|
119,484
|
|
102,265
|
Heron
Therapeutics, Inc.
|
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
June 30,
2023
|
|
December 31,
2022
|
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
13,462
|
|
$
15,364
|
Short-term
investments
|
|
19,782
|
|
69,488
|
Accounts receivable,
net
|
|
76,693
|
|
52,049
|
Inventory
|
|
44,623
|
|
54,573
|
Prepaid expenses and
other current assets
|
|
10,720
|
|
13,961
|
Total current
assets
|
|
165,280
|
|
205,435
|
Property and equipment,
net
|
|
20,873
|
|
22,160
|
Right-of-use lease
assets
|
|
6,488
|
|
7,645
|
Other assets
|
|
8,583
|
|
15,711
|
Total
assets
|
|
$
201,224
|
|
$
250,951
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,957
|
|
$
3,225
|
Accrued clinical and
manufacturing liabilities
|
|
19,881
|
|
24,468
|
Accrued payroll and
employee liabilities
|
|
9,856
|
|
13,416
|
Other accrued
liabilities
|
|
52,448
|
|
38,552
|
Current lease
liabilities
|
|
2,580
|
|
2,694
|
Total current
liabilities
|
|
86,722
|
|
82,355
|
Non-current lease
liabilities
|
|
4,158
|
|
5,499
|
Non-current
convertible notes payable, net
|
|
149,387
|
|
149,284
|
Other non-current
liabilities
|
|
241
|
|
241
|
Total
liabilities
|
|
240,508
|
|
237,379
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
|
1,199
|
|
1,191
|
Additional paid-in
capital
|
|
1,829,805
|
|
1,807,855
|
Accumulated other
comprehensive loss
|
|
(6)
|
|
(19)
|
Accumulated
deficit
|
|
(1,870,282)
|
|
(1,795,455)
|
Total stockholders'
equity (deficit)
|
|
(39,284)
|
|
13,572
|
Total liabilities and
stockholders' equity
|
|
$
201,224
|
|
$
250,951
|
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.