SAN DIEGO, March 2, 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 and twelve months ended December 31,
2019 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. In February 2020,
Heron announced that the FDA has extended the review period for the
NDA for HTX-011 by up to three months. The new 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.
An opinion from the EMA's Committee for Medicinal Products for
Human Use (CHMP) is anticipated in the second quarter 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. A decision by Health
Canada is anticipated in the third quarter of 2020.
CINV Franchise
- CINV 2019 Net Product Sales: For the three months ended
December 31, 2019,
chemotherapy-induced nausea and vomiting (CINV) franchise net
product sales were $35.1 million, up
22% from the same period in 2018. For the twelve months ended
December 31, 2019, CINV franchise net
product sales were $146.0 million, up
88% from the same period in 2018.
-
- CINVANTI® Net Product
Sales: Net product sales of CINVANTI (aprepitant)
injectable emulsion for the three and twelve months ended
December 31, 2019 were $34.6 million and $132.2
million, respectively, compared to $23.4 million and $56.2
million, respectively, for the same periods in 2018.
- SUSTOL® Net Product
Sales: Net product sales of SUSTOL (granisetron)
extended-release injection for the three and twelve months ended
December 31, 2019 were $0.5 million and $13.8
million, respectively, compared to $5.4 million and $21.3
million for the same periods in 2018. On October 1, 2019, the Company made a business
decision to discontinue all discounting of SUSTOL, which resulted
in significantly lower SUSTOL net product sales.
- 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 have made important advances in 2019 in both our pain
management and CINV franchises, highlighted by the advancement of
HTX-011 toward marketing approvals and strong sales for our CINV
franchise," said Barry Quart, Pharm.D., President and Chief
Executive Officer of Heron Therapeutics. "We look forward to
launching HTX-011 for postoperative pain management in the second
half of 2020, pending FDA approval."
Financial Results
Net product sales for the three and twelve months ended
December 31, 2019 were $35.1 million and $146.0
million, respectively, compared to $28.8 million and $77.5
million, respectively, for the same periods in 2018.
Heron's net loss for the three and twelve months ended
December 31, 2019 was $57.9 million and $204.7
million, or $0.65 per share
and $2.50 per share, respectively,
compared to $49.6 million and
$178.8 million, or $0.63 per share and $2.44 per share, respectively, for the same
periods in 2018. Net loss for the three and twelve months ended
December 31, 2019 included non-cash,
stock-based compensation expense of $11.1
million and $51.4 million,
respectively, compared to $9.8
million and $33.4 million,
respectively, for the same periods in 2018.
As of December 31, 2019, Heron had cash, cash equivalents
and short-term investments of $391.0 million compared to
$332.4 million as of December 31, 2018. Net cash used for operating
activities for the twelve months ended December 31, 2019 was $124.6 million, compared to $191.8 million for the same period in 2018. 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 agent, 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 (MMA) 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 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, except
par value amounts)
|
|
|
|
December
31,
2019
|
|
|
December
31,
2018
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
71,898
|
|
|
$
|
31,836
|
|
|
Short-term
investments
|
|
|
319,074
|
|
|
|
300,535
|
|
|
Accounts receivable,
net
|
|
|
39,879
|
|
|
|
64,652
|
|
|
Inventory
|
|
|
24,968
|
|
|
|
39,032
|
|
|
Prepaid expenses and
other current assets
|
|
|
23,245
|
|
|
|
11,193
|
|
|
Total current
assets
|
|
|
479,064
|
|
|
|
447,248
|
|
|
Property and
equipment, net
|
|
|
19,618
|
|
|
|
14,677
|
|
|
Right-of-use lease
assets
|
|
|
13,754
|
|
|
|
—
|
|
|
Other
assets
|
|
|
346
|
|
|
|
254
|
|
|
Total
assets
|
|
$
|
512,782
|
|
|
$
|
462,179
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,758
|
|
|
$
|
16,863
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
34,614
|
|
|
|
24,470
|
|
|
Accrued payroll and
employee liabilities
|
|
|
15,248
|
|
|
|
13,397
|
|
|
Other accrued
liabilities
|
|
|
36,535
|
|
|
|
32,715
|
|
|
Current lease
liabilities
|
|
|
1,926
|
|
|
|
—
|
|
|
Convertible notes
payable to related parties, net of discount
|
|
|
5,624
|
|
|
|
4,574
|
|
|
Total current
liabilities
|
|
|
96,705
|
|
|
|
92,019
|
|
|
Non-current lease
liabilities
|
|
|
12,242
|
|
|
|
—
|
|
|
Total
liabilities
|
|
|
108,947
|
|
|
|
92,019
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01
par value: 2,500 shares authorized; no shares issued or outstanding
at December 31, 2019 and 2018
|
|
|
—
|
|
|
|
—
|
|
|
Common stock, $0.01
par value: 150,000 shares authorized; 90,304 and 78,174 shares
issued and outstanding at December 31, 2019 and 2018,
respectively
|
|
|
903
|
|
|
|
782
|
|
|
Additional paid-in
capital
|
|
|
1,568,317
|
|
|
|
1,330,186
|
|
|
Accumulated other
comprehensive income (loss)
|
|
|
85
|
|
|
|
(87)
|
|
|
Accumulated
deficit
|
|
|
(1,165,470)
|
|
|
|
(960,721)
|
|
|
Total stockholders'
equity
|
|
|
403,835
|
|
|
|
370,160
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
512,782
|
|
|
$
|
462,179
|
|
|
HERON
THERAPEUTICS, INC.
|
|
Condensed
Consolidated Statements of Operations
|
|
(In thousands, except
per share amounts)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months Ended
December
31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
(unaudited)
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product sales
|
$
35,083
|
|
$
28,844
|
|
$
145,968
|
|
$
77,474
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product sales
|
15,874
|
|
11,572
|
|
61,619
|
|
27,512
|
|
Research and development
|
48,277
|
|
39,891
|
|
167,382
|
|
140,032
|
|
General and administrative
|
9,874
|
|
8,738
|
|
37,897
|
|
29,263
|
|
Sales and marketing
|
20,420
|
|
19,957
|
|
89,764
|
|
64,604
|
|
Total operating expenses
|
94,445
|
|
80,158
|
|
356,662
|
|
261,411
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(59,362)
|
|
(51,314)
|
|
(210,694)
|
|
(183,937)
|
|
|
|
|
|
|
|
|
|
Other income,
net
|
1,442
|
|
1,755
|
|
5,945
|
|
5,097
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(57,920)
|
|
$
(49,559)
|
|
$
(204,749)
|
|
$
(178,840)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.65)
|
|
$
(0.63)
|
|
$
(2.50)
|
|
$
(2.44)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
89,112
|
|
78,086
|
|
81,779
|
|
73,193
|
|
HERON
THERAPEUTICS, INC.
|
|
Consolidated
Statements of Cash Flows
|
|
(In
thousands)
|
|
|
|
Years Ended
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
Operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(204,749)
|
|
|
$
|
(178,840)
|
|
|
$
|
(197,484)
|
|
|
Adjustments to
reconcile net loss to net cash used for operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
51,411
|
|
|
|
33,367
|
|
|
|
30,538
|
|
|
Depreciation and
amortization
|
|
|
2,044
|
|
|
|
1,513
|
|
|
|
1,531
|
|
|
Amortization of debt
discount
|
|
|
1,050
|
|
|
|
890
|
|
|
|
773
|
|
|
Accretion of discount
on short-term investments
|
|
|
(3,730)
|
|
|
|
(3,412)
|
|
|
|
(278)
|
|
|
Realized gain on
available-for-sale investments
|
|
|
(8)
|
|
|
|
—
|
|
|
|
—
|
|
|
Impairment of property
and equipment
|
|
|
107
|
|
|
|
72
|
|
|
|
—
|
|
|
Loss on disposal of
property and equipment
|
|
|
62
|
|
|
|
29
|
|
|
|
39
|
|
|
Change in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
24,773
|
|
|
|
(22,778)
|
|
|
|
(39,914)
|
|
|
Prepaid expenses and
other assets
|
|
|
(12,052)
|
|
|
|
(7,482)
|
|
|
|
3
|
|
|
Inventory
|
|
|
14,064
|
|
|
|
(29,122)
|
|
|
|
(4,768)
|
|
|
Accounts
payable
|
|
|
(14,105)
|
|
|
|
(1,906)
|
|
|
|
11,955
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
10,144
|
|
|
|
(3,614)
|
|
|
|
13,713
|
|
|
Accrued payroll and
employee liabilities
|
|
|
1,851
|
|
|
|
4,537
|
|
|
|
446
|
|
|
Deferred
revenue
|
|
|
—
|
|
|
|
—
|
|
|
|
1,664
|
|
|
Other accrued
liabilities
|
|
|
4,558
|
|
|
|
14,941
|
|
|
|
11,482
|
|
|
Net cash used for
operating activities
|
|
|
(124,580)
|
|
|
|
(191,805)
|
|
|
|
(170,300)
|
|
|
Investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of
short-term investments
|
|
|
(477,035)
|
|
|
|
(497,104)
|
|
|
|
(121,570)
|
|
|
Maturities and sales
of short-term investments
|
|
|
462,406
|
|
|
|
227,700
|
|
|
|
131,783
|
|
|
Purchases of property
and equipment
|
|
|
(7,154)
|
|
|
|
(9,171)
|
|
|
|
(2,553)
|
|
|
Proceeds from the
sale of property and equipment
|
|
|
—
|
|
|
|
25
|
|
|
|
78
|
|
|
Net cash (used for)
provided by investing activities
|
|
|
(21,783)
|
|
|
|
(278,550)
|
|
|
|
7,738
|
|
|
Financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from
sale of common stock and/or pre-funded warrants
|
|
|
162,151
|
|
|
|
363,128
|
|
|
|
306,279
|
|
|
Proceeds from
purchases under the Employee Stock Purchase Plan
|
|
|
2,109
|
|
|
|
1,179
|
|
|
|
989
|
|
|
Proceeds from stock
option exercises
|
|
|
22,164
|
|
|
|
18,301
|
|
|
|
11,463
|
|
|
Proceeds from warrant
exercises
|
|
|
1
|
|
|
|
—
|
|
|
|
—
|
|
|
Repayment of
promissory note payable to related party
|
|
|
—
|
|
|
|
(25,000)
|
|
|
|
(25,000)
|
|
|
Net cash provided by
financing activities
|
|
|
186,425
|
|
|
|
357,608
|
|
|
|
293,731
|
|
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
40,062
|
|
|
|
(112,747)
|
|
|
|
131,169
|
|
|
Cash and cash
equivalents at beginning of year
|
|
|
31,836
|
|
|
|
144,583
|
|
|
|
13,414
|
|
|
Cash and cash
equivalents at end of year
|
|
$
|
71,898
|
|
|
$
|
31,836
|
|
|
$
|
144,583
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
$
|
—
|
|
|
$
|
1,183
|
|
|
$
|
2,789
|
|
|
Cumulative effect of
adoption of new accounting standard
|
|
$
|
—
|
|
|
$
|
1,574
|
|
|
$
|
—
|
|
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-and-twelve-months-ended-december-31-2019-and-highlights-recent-corporate-updates-301013982.html
SOURCE Heron Therapeutics, Inc.