- 2023 oncology care franchise revenue was $107.9 million, exceeding full-year 2023
guidance
- ZYNRELEF® achieved quarterly record of
$5.6 million in Q4 Net Product
Sales
- Ended 2023 with cash and cash equivalents of $80.4 million
- Announced partnership with CrossLink Life Sciences, LLC to
expand ZYNRELEF promotional efforts on January 7, 2024
- Received FDA approval for expanded indication of ZYNRELEF on
January 23, 2024
SAN
DIEGO, March 12, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a
commercial-stage biotechnology company, today announced financial
results for the three and twelve months ended December 31, 2023 and highlighted recent
corporate updates.
"In the fourth quarter of 2023, Heron saw continued positive
momentum and an increased sales trajectory in both our acute care
and oncology care franchises, illustrating how the strategic
decisions made over the past year have positioned the Company for
long-term success and profitability," said Craig Collard, Chief Executive Officer of Heron.
"I am pleased to share this quarterly update and look forward to
building upon what we achieved in the fourth quarter of 2023,
providing substantial value and meaningful solutions in the acute
care and oncology care settings."
Business Highlights
- The ZYNRELEF Vial Access Needle ("VAN") program, to allow for
the rapid preparation and administration of ZYNRELEF in the
operating room, remains on track for a Prior Approval Supplement
("PAS") submission in Q2 2024 and an anticipated launch in the
second half of 2024.
- The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate
use of ZYNRELEF, continues to progress with an expected submission
for approval in 2026.
- Gross Margin improved to 71% for the quarter, up from 58% in
the same period last year.
- ZYNRELEF generated record quarterly revenues of approximately
$5.6 million.
- The CrossLink Life Sciences, LLC partnership finalized on
January 7, 2024, will ultimately
provide up to 650 additional sales representatives promoting
ZYNRELEF to orthopedic surgeons.
- Received FDA approval of our supplemental New Drug Application
("sNDA") for ZYNRELEF which expands the ZYNRELEF label to
approximately 13 million procedures annually.
Financial Guidance for 2024
The Company reaffirms its full-year 2024 guidance for Product
Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Product Revenues,
Net
|
$138.0 to $158.0 million
|
|
|
Adjusted Operating
Expenses
(Excluding Stock-Based Compensation and Depreciation and
Amortization)
|
$108.0 to $116.0 million
|
|
|
Adjusted EBITDA
(Excluding Stock-Based Compensation and Depreciation and
Amortization)
|
$(22.0) to $3.0 million
|
Acute Care Franchise
- Acute Care Franchise Net Product Sales: For the three
and twelve months ended December 31,
2023, acute care franchise Net Product Sales were
$6.1 million and $19.1 million, respectively, which increased from
$3.9 million and $10.2 million, respectively, for the same periods
in 2022.
- ZYNRELEF Net Product Sales: Net Product Sales of
ZYNRELEF (bupivacaine and meloxicam) extended-release solution for
the three and twelve months ended December
31, 2023 were $5.6 million and
$17.7 million, respectively, which
increased from $3.9 million and
$10.2 million, respectively, for the
same periods in 2022.
- APONVIE® Net Product Sales: Net
Product Sales of APONVIE for the three and twelve months ended
December 31, 2023 were $0.5 million and $1.4
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 twelve months ended December 31,
2023, oncology care franchise Net Product Sales were
$28.1 million and $107.9 million, respectively, which increased
from $26.1 million and $97.5 million, respectively, for the same periods
in 2022.
- CINVANTI® Net Product Sales:
Net Product Sales of CINVANTI (aprepitant) injectable emulsion for
the three and twelve months ended December
31, 2023 were $24.3 million
and $94.9 million, respectively,
which increased from $23.1 million
and $87.3 million, respectively, for
the same periods in 2022.
- SUSTOL® Net Product Sales: Net Product
Sales of SUSTOL (granisetron) extended-release injection for the
three and twelve months ended December 31,
2023 were $3.8 million and
$13.0 million, respectively, which
increased from $3.0 million and
$10.2 million, respectively, for the
same periods in 2022.
Conference Call and Webcast
Heron will host a conference call and webcast on March 12th, 2024 at 4:30
pm 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 6135354 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
to include foot and ankle, small-to-medium open abdominal, and
lower extremity total joint arthroplasty surgical procedures. On
January 23, 2024, the FDA approved
ZYNRELEF for soft tissue and orthopedic surgical procedures
including foot and ankle, and other procedures in which direct
exposure to articular cartilage is avoided. 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.
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis,
we have included information about certain non-GAAP financial
measures. We believe the presentation of these non-GAAP financial
measures, when viewed with our results under GAAP and the
accompanying reconciliations, provide analysts, investors, lenders,
and other third parties with insights into how we evaluate normal
operational activities, including our ability to generate cash from
operations, on a comparable year-over-year basis and manage our
budgeting and forecasting.
In our quarterly and annual reports, earnings press releases and
conference calls, we may discuss the following financial measures
that are not calculated in accordance with GAAP, to supplement our
consolidated financial statements presented on a GAAP basis.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents
GAAP net income or loss adjusted to exclude interest expense,
interest income, the benefit from or provision for income taxes,
depreciation, amortization, stock-based compensation, and other
adjustments to reflect changes that occur in our business but do
not represent ongoing operations. Adjusted EBITDA, as used by us,
may be calculated differently from, and therefore may not be
comparable to, similarly titled measures used by other
companies.
There are several limitations related to the use of adjusted
EBITDA rather than net income or loss, which is the nearest GAAP
equivalent, such as:
- adjusted EBITDA excludes depreciation and amortization, and,
although these are non-cash expenses, the assets being depreciated
or amortized may have to be replaced in the future, the cash
requirements for which are not reflected in adjusted EBITDA;
- we exclude stock-based compensation expense from adjusted
EBITDA although: (i) it has been, and will continue to be for the
foreseeable future, a significant recurring expense for our
business and an important part of our compensation strategy; and
(ii) if we did not pay out a portion of our compensation in the
form of stock-based compensation, the cash salary expense included
in operating expenses would be higher, which would affect our cash
position;
- adjusted EBITDA does not reflect changes in, or cash
requirements for, working capital needs;
- adjusted EBITDA does not reflect the benefit from or provision
for income taxes or the cash requirements to pay taxes;
- adjusted EBITDA does not reflect historical cash expenditures
or future requirements for capital expenditures or contractual
commitments;
- we exclude restructuring expenses from adjusted EBITDA.
Restructuring expenses primarily include employee severance and
contract termination costs that are not related to acquisitions.
The amount and/or frequency of these restructuring expenses are not
part of our underlying business;
Adjusted Operating Expenses
Adjusted operating expenses is a non-GAAP financial measure that
represents GAAP operating expenses adjusted to exclude stock-based
compensation expense, depreciation and amortization, and other
adjustments to reflect changes that occur in our business but do
not represent ongoing operations.
Reconciliations of adjusted EBITDA and adjusted operating
expenses to the most directly comparable GAAP financial measures
are included in this press release.
The Company has not provided a reconciliation of its full-year
2024 guidance for adjusted EBITDA or adjusted operating expenses to
the most directly comparable forward-looking GAAP measures, in
reliance on the unreasonable efforts exception provided under Item
10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to
predict, without unreasonable efforts, the timing and amount of
items that would be included in such a reconciliation, including,
but not limited to, stock-based compensation expense, acquisition
related expense and litigation settlements. These items are
uncertain and depend on various factors that are outside of the
Company's control or cannot be reasonably predicted. While the
Company is unable to address the probable significance of these
items, they could have a material impact on GAAP net income and
operating expenses for the guidance period.
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. Therefore,
you should not place undue reliance on forward-looking statements.
Examples of forward-looking statements include, among others,
statements we make regarding the potential market opportunities for
ZYNRELEF, APONVIE, CINVANTI and SUSTOL; revenue, adjusted EBITDA
and other financial guidance provided by the Company; the results
of the commercial launch of APONVIE; the potential additional
market opportunity for the expanded U.S. label for ZYNRELEF; the
timing of the Company's development of the VAN program and receipt
of required regulatory approvals; our ability to establish and
maintain successful commercial arrangements like our co-promotion
agreement CrossLink Life Sciences; the outcome of the
Company's pending ANDA litigation; 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.
Important factors that could cause actual results to differ
materially from those in the forward-looking statements are set
forth in our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission, including under
the caption "Risk Factors." 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
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
(unaudited)
|
|
|
|
|
Net product
sales
|
|
$
34,233
|
|
$
30,028
|
|
$
127,044
|
|
$ 107,672
|
Cost of product
sales
|
|
9,885
|
|
12,627
|
|
65,105
|
|
54,874
|
Gross profit
|
|
24,348
|
|
17,401
|
|
61,939
|
|
52,798
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
10,950
|
|
11,057
|
|
55,897
|
|
107,506
|
General and
administrative
|
|
11,290
|
|
8,924
|
|
49,014
|
|
37,437
|
Sales and
marketing
|
|
12,328
|
|
17,775
|
|
67,643
|
|
82,513
|
Total operating
expenses
|
|
34,568
|
|
37,756
|
|
172,554
|
|
227,456
|
Loss from
operations
|
|
(10,220)
|
|
(20,355)
|
|
(110,615)
|
|
(174,658)
|
Other income
(expense), net
|
|
(504)
|
|
486
|
|
56
|
|
(7,366)
|
Net loss
|
|
$
(10,724)
|
|
$
(19,869)
|
|
$ (110,559)
|
|
$
(182,024)
|
Basic and diluted net
loss per share
|
|
$
(0.07)
|
|
$
(0.17)
|
|
$
(0.80)
|
|
$
(1.67)
|
Heron Therapeutics,
Inc.
Consolidated Balance
Sheets
(in
thousands)
|
|
|
|
December 31,
2023
|
|
December 31,
2022
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
28,677
|
|
$
15,364
|
Short-term
investments
|
|
51,732
|
|
69,488
|
Accounts receivable,
net
|
|
60,137
|
|
52,049
|
Inventory
|
|
42,110
|
|
54,573
|
Prepaid expenses and
other current assets
|
|
6,118
|
|
13,961
|
Total current
assets
|
|
188,774
|
|
205,435
|
Property and equipment,
net
|
|
20,166
|
|
22,160
|
Right-of-use lease
assets
|
|
5,438
|
|
7,645
|
Other assets
|
|
8,128
|
|
15,711
|
Total
assets
|
|
$
222,506
|
|
$
250,951
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
3,240
|
|
$
3,225
|
Accrued clinical and
manufacturing liabilities
|
|
22,291
|
|
24,468
|
Accrued payroll and
employee liabilities
|
|
9,224
|
|
13,416
|
Other accrued
liabilities
|
|
41,855
|
|
38,552
|
Current lease
liabilities
|
|
3,075
|
|
2,694
|
Total current
liabilities
|
|
79,685
|
|
82,355
|
Non-current lease
liabilities
|
|
2,800
|
|
5,499
|
Non-current notes
payable, net
|
|
24,263
|
|
—
|
Non-current
convertible notes payable, net
|
|
149,490
|
|
149,284
|
Other non-current
liabilities
|
|
241
|
|
241
|
Total
liabilities
|
|
256,479
|
|
237,379
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
1,503
|
|
1,191
|
Additional paid-in
capital
|
|
1,870,525
|
|
1,807,855
|
Accumulated other
comprehensive income (loss)
|
|
13
|
|
(19)
|
Accumulated
deficit
|
|
(1,906,014)
|
|
(1,795,455)
|
Total stockholders'
equity
|
|
(33,973)
|
|
13,572
|
Total liabilities and
stockholders' equity
|
|
$
222,506
|
|
$
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.