- Heron is increasing full-year 2023 Net Product Sales
guidance for the oncology care franchise to a range of $104 million to $106
million from a prior range of $99
million to $103
million
- We anticipate full-year 2023 Net Product Sales to be in the
range of $123 million to $125 million and full-year 2024 Net Product Sales
to be in the range of $138 million to
$158 million
- Full-year 2024 EBITDA (excluding stock compensation)
expected to be in the range of ($22
million) to $3
million
- Cost reduction plan implemented decreasing operating
expenses (excluding stock compensation and depreciation and
amortization) by 26% in 2023 compared to 2022 and full-year 2024
operating expenses (excluding stock compensation and depreciation
and amortization) are expected to be in the range of $108 million to $116
million
SAN
DIEGO, Nov. 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 nine months ended September 30, 2023 and highlighted recent
corporate updates.
Craig Collard, Chief Executive
Officer, commented, "In just six months of initiating our corporate
restructuring plan, I am pleased to announce its near completion.
The enhanced clarity in our sales projections and operational
visibility brings optimism for our path to profitability. I
am delighted to offer this quarterly update on our expectations for
the fourth quarter and to unveil our 2024 guidance. Heron is
now strategically positioned to deliver substantial value in the
coming years, boasting a robust balance sheet, a dedicated
management team, and a steadfast commitment to operational
excellence."
Corporate Updates
- Guidance for 2023 and 2024:
-
- The Company is updating guidance for the remainder of 2023 and
establishing guidance for the full year 2024 that reflects the
growth potential of the product portfolio and the output of our
continual operational improvements. Based on our current
operational plan, we expect the Company to have sufficient capital
to achieve profitability:
- Full-year 2023 net product sales are expected to be in the
range of $123 million to $125 million.
- Full-year 2023 net product sales guidance for the oncology care
franchise is being increased to a range of $104 million to $106
million from a prior range of $99
million to $103 million.
- EBITDA (excluding stock compensation) expected in the range of
($10 million) to ($6 million) in the fourth quarter of 2023.
- Full-year 2024 net product sales are expected to be in the
range of $138 million to $158 million, with our oncology care franchise
growing 3% to 5% in 2024 over 2023. and the acute care franchise
growing in excess of 48% year-over-year.
- Full-year 2024 operating expenses (excluding stock
compensation, depreciation and amortization) are expected to be in
the range of $108 million to
$116 million
- Full-year 2024 EBITDA (excluding stock compensation) expected
to be in the range of ($22 million)
to $3 million.
- Positive EBITDA (excluding stock compensation) is expected
during the fourth quarter of 2024.
- Expected year-end 2023 cash, cash equivalents, and short-term
investments to exceed $65 million
with additional access to $25 million
from our working capital facility.
- Gross margin is expected to improve from 41% in 2023 to 69% in
2024, and to over 75% in 2025 and beyond.
- Adjustments during Third Quarter 2023:
- Inventory write-offs during the quarter totaled $7.5 million as a reflection of our reforecast of
the ZYNRELEF® product launch. Had we not incurred
the write-offs, gross profit for the quarter would have been
$20.7 million, or a gross margin of
approximately 66%. We do not currently anticipate additional
inventory write-offs in the future.
- One-time expenses during the quarter were $4.1 million, consisting of reorganization costs
and severance charges.
- Loss from operations was $24.9
million for the quarter. Excluding inventory write-offs and
one-time expenses, loss from operations would have been
$13.3 million.
- Financings:
- In July 2023, Heron completed a
private placement equity financing with net proceeds from the sale
of Company's common stock and pre-funded warrants of $29.8 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 $24.4
million in net proceeds drawn at closing.
- Product Development: The Vial Access Needle ("VAN")
program remains on track for a Prior Approval Supplement ("PAS")
submission in early 2024 and an anticipated launch in the third
quarter of 2024.
Acute Care Franchise
- Acute Care Franchise Net Product Sales: For the three
and nine months ended September 30,
2023, acute care franchise net product sales were
$4.7 million and $12.9 million, respectively, which increased from
$2.7 million and $6.3 million, respectively, for the same periods
in 2022.
- ZYNRELEF Net Product Sales and PDUFA Date:
- Net product sales of ZYNRELEF (bupivacaine and meloxicam)
extended-release solution for the three and nine months ended
September 30, 2023 were $4.4 million and $12.0
million, respectively, which increased from $2.7 million and $6.3
million, respectively, for the same periods in 2022.
- The Prescription Drug User Fee Act ("PDUFA") action date for
the supplemental New Drug Application ("sNDA") for the ZYNRELEF
expanded label is on track for January 23,
2024.
- APONVIE® Net Product Sales: Net
product sales of APONVIE for the three and nine months ended
September 30, 2023 were $0.3 million and $0.9
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 nine months ended September 30,
2023, oncology care franchise net product sales were
$26.7 million and $79.9 million, respectively, which increased from
$23.9 million and $71.3 million, respectively, for the same periods
in 2022.
- CINVANTI® Net Product Sales:
Net product sales of CINVANTI (aprepitant) injectable emulsion for
the three and nine months ended September
30, 2023 were $23.3 million
and $70.6 million, respectively,
which increased from $21.2 million
and $64.2 million, respectively, for
the same periods in 2022.
- CINVANTI ANDA Litigation: Heron 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 nine months ended September 30,
2023 were $3.4 million and
$9.3 million, respectively, which
increased from $2.7 million and
$7.1 million, respectively, for the
same periods in 2022.
Conference Call and Webcast
Heron will host a conference call and webcast on November 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 5940799 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 U.S. Food and Drug Administration (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 ZYNRELEF U.K. marketing authorization
and, in October 2023, we cancelled
the ZYNRELEF European Union (EU) marketing authorization, as we do
not plan to commercially launch ZYNRELEF in the U.K. or the EU.
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 EBITDA guidance
provided by the Company; 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 timing of the Company's
development of the VAN program; the timing of the Company's
submission of the PAS to the FDA for the VAN; the timing of the
FDA's review process and whether the FDA approves the PAS for the
VAN; the outcome of the Company's pending ANDA litigation related
to CINVANTI; whether the Company is required to write-off any
additional inventory in the future; 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; 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
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
31,434
|
|
$
26,557
|
|
$ 92,811
|
|
$ 77,644
|
Cost of product
sales
|
|
18,208
|
|
14,717
|
|
55,220
|
|
42,247
|
Gross
profit
|
|
13,226
|
|
11,840
|
|
37,591
|
|
35,397
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
13,558
|
|
25,545
|
|
44,947
|
|
96,449
|
General and
administrative
|
|
11,641
|
|
9,799
|
|
37,724
|
|
28,513
|
Sales and
marketing
|
|
12,956
|
|
18,378
|
|
55,315
|
|
64,738
|
Total operating
expenses
|
|
38,155
|
|
53,722
|
|
137,986
|
|
189,700
|
Loss from
operations
|
|
(24,929)
|
|
(41,882)
|
|
(100,395)
|
|
(154,303)
|
Other income
(expense), net
|
|
(79)
|
|
(26)
|
|
560
|
|
(7,852)
|
Net loss
|
|
$
(25,008)
|
|
$
(41,908)
|
|
$
(99,835)
|
|
$
(162,155)
|
Basic and diluted net
loss per share
|
|
$ (0.17)
|
|
$ (0.38)
|
|
$
(0.75)
|
|
$
(1.54)
|
Heron Therapeutics,
Inc. Consolidated Balance Sheets
(in thousands)
|
|
|
|
September 30,
2023
|
|
December 31,
2022
|
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
34,859
|
|
$
15,364
|
Short-term
investments
|
|
42,553
|
|
69,488
|
Accounts receivable,
net
|
|
63,795
|
|
52,049
|
Inventory
|
|
42,007
|
|
54,573
|
Prepaid expenses and
other current assets
|
|
10,765
|
|
13,961
|
Total current
assets
|
|
193,979
|
|
205,435
|
Property and equipment,
net
|
|
20,785
|
|
22,160
|
Right-of-use lease
assets
|
|
6,069
|
|
7,645
|
Other assets
|
|
8,366
|
|
15,711
|
Total
assets
|
|
$
229,199
|
|
$
250,951
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,860
|
|
$
3,225
|
Accrued clinical and
manufacturing liabilities
|
|
24,740
|
|
24,468
|
Accrued payroll and
employee liabilities
|
|
10,376
|
|
13,416
|
Other accrued
liabilities
|
|
39,770
|
|
38,552
|
Current lease
liabilities
|
|
2,999
|
|
2,694
|
Total current
liabilities
|
|
79,745
|
|
82,355
|
Non-current lease
liabilities
|
|
3,537
|
|
5,499
|
Non-current notes
payable, net
|
|
24,023
|
|
—
|
Non-current
convertible notes payable, net
|
|
149,439
|
|
149,284
|
Other non-current
liabilities
|
|
241
|
|
241
|
Total
liabilities
|
|
256,985
|
|
237,379
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
|
1,411
|
|
1,191
|
Additional paid-in
capital
|
|
1,866,094
|
|
1,807,855
|
Accumulated other
comprehensive loss
|
|
(1)
|
|
(19)
|
Accumulated
deficit
|
|
(1,895,290)
|
|
(1,795,455)
|
Total stockholders'
equity (deficit)
|
|
(27,786)
|
|
13,572
|
Total liabilities and
stockholders' equity
|
|
$
229,199
|
|
$
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.