SAN DIEGO, May 6, 2020 /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 months ended March 31, 2020 and
highlighted recent corporate updates.
Recent Corporate Updates
Pain Management Franchise
- New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for HTX-011, an investigational agent for the management of
postoperative pain. The Prescription Drug User Fee Act (PDUFA) goal
date is June 26, 2020.
- Contract Manufacturing Site for HTX-011: In February 2020, Heron announced that the contract
manufacturing site used to manufacture HTX-011 has been reinspected
by the FDA with no Form 483 observations issued and with a
recommendation by the FDA inspector for approval of the site. Heron
has not been informed of any other manufacturing concerns.
- Marketing Authorisation Application for HTX-011 in the
European Union: In March 2019,
Heron's Marketing Authorisation Application (MAA) for HTX-011 for
the management of postoperative pain was validated by the European
Medicines Agency (EMA) for review under the Centralised Procedure.
The medical device certification required for approval in the
European Union (EU) for the custom Luer lock applicator developed
for application of HTX-011 without a needle was delayed. An opinion
from the EMA's Committee for Medicinal Products for Human Use
(CHMP) is now anticipated in the second half of 2020.
- New Drug Submission for HTX-011 in Canada: In December
2019, Heron's New Drug Submission (NDS) for HTX-011 for the
management of postoperative pain was granted Priority Review status
and accepted by Health Canada. Health Canada's Priority Review status provides an
accelerated 6-month review target for the NDS. Heron received the
Certificate of Registration for the custom Luer lock applicator
issued under the Medical Devices Single Audit Program for the
medical device license in Canada.
A decision by Health Canada on the NDS is anticipated in the third
quarter of 2020.
CINV Franchise
- CINV Net Product Sales: For the three months ended
March 31, 2020, chemotherapy-induced
nausea and vomiting (CINV) franchise net product sales were
$25.4 million, compared to
$31.6 million for the same period in
2019.
-
- CINVANTI® Net Product Sales: Net
product sales of CINVANTI (aprepitant) injectable emulsion for the
three months ended March 31, 2020
were $25.2 million, compared to
$28.0 million for the same period in
2019. Heron expects the impact of the generic arbitrage to be
resolved in 2020, with a return to growth in 2021 and beyond
- SUSTOL® Net Product Sales: Net product
sales of SUSTOL (granisetron) extended-release injection for the
three months ended March 31, 2020
were $0.2 million, compared to
$3.6 million for the same period in
2019. On October 1, 2019, the Company
discontinued all discounting of SUSTOL, which resulted in
significantly lower SUSTOL net product sales. Heron expects SUSTOL
to return to growth in 2021 and beyond.
- 2020 Net Product Sales Guidance: Heron expects 2020 net
product sales for the CINV franchise of $70
million to $80 million and the
CINV franchise to return to growth in 2021 and beyond.
"We are encouraged by a recent communication with the FDA where
they indicated that they continue on schedule with their review of
the NDA for HTX-011, with a PDUFA date of June 26, 2020," said Barry Quart, Pharm.D.,
President and Chief Executive Officer of Heron. "For the CINV
franchise, our customers are benefiting from the administration of
CINVANTI by 2-minute IV push, an important product advantage
compared to competitive products, which has led to strong
first-quarter net product sales of $25.4
million."
Financial Results
Net product sales for the three months ended March 31, 2020 were $25.4
million, compared to $31.6
million for the same period in 2019.
Heron's net loss for the three months ended March 31, 2020 was $51.6
million, or $0.57 per share,
compared to $63.0 million, or
$0.80 per share, for the same period
in 2019. Net loss for the three months ended March 31, 2020 included non-cash, stock-based
compensation expense of $12.0
million, compared to $17.9
million for the same period in 2019.
As of March 31, 2020, Heron had cash, cash equivalents and
short-term investments of $356.3 million, compared to
$391.0 million as of December 31, 2019. Net cash used for operating
activities for the three months ended March
31, 2020 was $32.9 million,
compared to $49.0 million for the
same period in 2019. Heron expects that its current cash, cash
equivalents and short-term investments will be sufficient to fund
its operations into 2022.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid, is a dual-acting,
fixed-dose combination of the local anesthetic bupivacaine with a
low dose of the nonsteroidal anti-inflammatory drug meloxicam.
It is the first and only extended-release local anesthetic to
demonstrate in Phase 3 studies significantly reduced pain and
opioid use through 72 hours compared to bupivacaine solution, the
current standard-of-care local anesthetic for postoperative pain
control. HTX-011 was granted Fast Track designation from the U.S.
Food and Drug Administration (FDA) in the fourth quarter of 2017
and Breakthrough Therapy designation in the second quarter of 2018.
Heron submitted a New Drug Application (NDA) to the FDA for HTX-011
in October of 2018 and received Priority Review designation in
December of 2018. A Complete Response Letter (CRL) was received
from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry,
manufacturing and controls and non-clinical information. No issues
related to clinical efficacy or safety were noted. Heron
resubmitted an NDA to the FDA for HTX-011 in September 2019. The Prescription Drug User Fee
Act (PDUFA) goal date is June 26, 2020. A Marketing
Authorisation Application (MAA) for HTX-011 was validated by the
European Medicines Agency (EMA) in March
2019 for review under the Centralised Procedure. Heron's New
Drug Submission (NDS) for HTX-011 for the management of
postoperative pain was granted Priority Review status by Health
Canada in October 2019 and accepted
by Health Canada in November
2019.
About CINVANTI (Aprepitant) Injectable Emulsion
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, a
substance P/neurokinin-1 (NK1) receptor antagonist (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 United States 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 (Granisetron) Extended-Release Injection
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-HT3 receptor antagonist 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. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents for patients suffering from
pain or cancer.
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, those associated with: whether the U.S. Food
and Drug Administration (FDA) approves the New Drug
Application (NDA) for HTX-011; the timing of the commercial launch
of HTX-011; the timing of the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) review
process for HTX-011; whether the European Commission
(EC) authorizes the Marketing Authorisation
Application (MAA) for HTX-011; the timing of Health
Canada's New Drug Submission (NDS) review process for HTX-011;
whether Health Canada issues a Notice of Compliance for the
NDS for HTX-011; the full-year 2020 net product sales guidance for
the CINV 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; 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 Balance
Sheets
|
|
(In
thousands)
|
|
|
|
March
31,
2020
|
|
|
December
31,
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
103,285
|
|
|
$
|
71,898
|
|
|
Short-term
investments
|
|
|
253,061
|
|
|
|
319,074
|
|
|
Accounts receivable,
net
|
|
|
34,811
|
|
|
|
39,879
|
|
|
Inventory
|
|
|
34,849
|
|
|
|
24,968
|
|
|
Prepaid expenses and
other current assets
|
|
|
12,442
|
|
|
|
23,245
|
|
|
Total current
assets
|
|
|
438,448
|
|
|
|
479,064
|
|
|
Property and
equipment, net
|
|
|
21,908
|
|
|
|
19,618
|
|
|
Right-of-use lease
assets
|
|
|
18,239
|
|
|
|
13,754
|
|
|
Other
assets
|
|
|
346
|
|
|
|
346
|
|
|
Total
assets
|
|
$
|
478,941
|
|
|
$
|
512,782
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
11,562
|
|
|
$
|
2,758
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
35,321
|
|
|
|
34,614
|
|
|
Accrued payroll and
employee liabilities
|
|
|
8,770
|
|
|
|
15,248
|
|
|
Other accrued
liabilities
|
|
|
32,423
|
|
|
|
36,535
|
|
|
Current lease
liabilities
|
|
|
2,755
|
|
|
|
1,926
|
|
|
Convertible notes
payable to related parties, net of discount
|
|
|
5,934
|
|
|
|
5,624
|
|
|
Total current
liabilities
|
|
|
96,765
|
|
|
|
96,705
|
|
|
Non-current lease
liabilities
|
|
|
16,708
|
|
|
|
12,242
|
|
|
Total
liabilities
|
|
|
113,473
|
|
|
|
108,947
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
906
|
|
|
|
903
|
|
|
Additional paid-in
capital
|
|
|
1,580,903
|
|
|
|
1,568,317
|
|
|
Accumulated other
comprehensive income
|
|
|
708
|
|
|
|
85
|
|
|
Accumulated
deficit
|
|
|
(1,217,049)
|
|
|
|
(1,165,470)
|
|
|
Total stockholders'
equity
|
|
|
365,468
|
|
|
|
403,835
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
478,941
|
|
|
$
|
512,782
|
|
|
|
|
|
|
|
|
|
|
|
|
HERON
THERAPEUTICS, INC.
|
|
Condensed
Consolidated Statements of Operations
|
|
(In thousands, except
per share amounts)
|
|
|
Three Months
Ended
March
31,
|
|
|
2020
|
|
2019
|
|
|
(Unaudited)
|
|
|
Revenues:
|
|
|
|
|
|
Net product sales
|
$
25,400
|
|
$
31,602
|
|
|
Operating
expenses:
|
|
|
|
|
|
Cost of product sales
|
10,622
|
|
14,962
|
|
|
Research and development
|
36,894
|
|
42,972
|
|
|
General and administrative
|
10,422
|
|
9,648
|
|
|
Sales and marketing
|
20,196
|
|
28,720
|
|
|
Total operating expenses
|
78,134
|
|
96,302
|
|
|
|
|
|
|
|
Loss from
operations
|
(52,734)
|
|
(64,700)
|
|
|
|
|
|
|
|
Other income,
net
|
1,155
|
|
1,688
|
|
|
|
|
|
|
|
Net loss
|
$
(51,579)
|
|
$
(63,012)
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.57)
|
|
$
(0.80)
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
90,409
|
|
78,419
|
|
|
HERON
THERAPEUTICS, INC.
|
|
Consolidated
Statements of Cash Flows
|
|
(In
thousands)
|
|
|
|
|
|
Three Months
Ended
March
31,
|
|
|
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
(Unaudited)
|
|
|
Operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(51,579)
|
|
|
$
|
(63,012)
|
|
|
Adjustments to
reconcile net loss to net cash used for operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
|
|
11,974
|
|
|
|
17,902
|
|
|
Depreciation and
amortization
|
|
|
|
|
621
|
|
|
|
467
|
|
|
Amortization of debt
discount
|
|
|
|
|
310
|
|
|
|
247
|
|
|
Realized gain on
available-for-sale securities
|
|
|
|
|
—
|
|
|
|
(8)
|
|
|
Accretion of discount
on short-term investments
|
|
|
|
|
(117)
|
|
|
|
(1,357)
|
|
|
Impairment of property
and equipment
|
|
|
|
|
27
|
|
|
|
27
|
|
|
Loss on disposal of
property and equipment
|
|
|
|
|
—
|
|
|
|
52
|
|
|
Change in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
|
5,068
|
|
|
|
(9,355)
|
|
|
Prepaid expenses and
other assets
|
|
|
|
|
10,803
|
|
|
|
(346)
|
|
|
Inventory
|
|
|
|
|
(9,881)
|
|
|
|
7,611
|
|
|
Accounts
payable
|
|
|
|
|
8,804
|
|
|
|
(6,052)
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
|
|
707
|
|
|
|
(868)
|
|
|
Accrued payroll and
employee liabilities
|
|
|
|
|
(6,478)
|
|
|
|
(6,757)
|
|
|
Other accrued
liabilities
|
|
|
|
|
(3,194)
|
|
|
|
12,425
|
|
|
Net cash used for
operating activities
|
|
|
|
|
(32,935)
|
|
|
|
(49,024)
|
|
|
Investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of
short-term investments
|
|
|
|
|
(28,922)
|
|
|
|
(127,763)
|
|
|
Maturities and sales
of short-term investments
|
|
|
|
|
95,675
|
|
|
|
164,009
|
|
|
Purchases of property
and equipment
|
|
|
|
|
(2,938)
|
|
|
|
(2,136)
|
|
|
Net cash provided by
investing activities
|
|
|
|
|
63,815
|
|
|
|
34,110
|
|
|
Financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from stock
option exercises
|
|
|
|
|
504
|
|
|
|
6,539
|
|
|
Proceeds from warrant
exercises
|
|
|
|
|
3
|
|
|
|
—
|
|
|
Net cash provided by
financing activities
|
|
|
|
|
507
|
|
|
|
6,539
|
|
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
|
|
31,387
|
|
|
|
(8,375)
|
|
|
Cash and cash
equivalents at beginning of year
|
|
|
|
|
71,898
|
|
|
|
31,836
|
|
|
Cash and cash
equivalents at end of period
|
|
|
|
$
|
103,285
|
|
|
$
|
23,461
|
|
Investor Relations and Media Contact:
David Szekeres
Chief Legal, Business and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
View original
content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-months-ended-march-31-2020-and-highlights-recent-corporate-updates-301053524.html
SOURCE Heron Therapeutics, Inc.