SAN DIEGO, Aug. 5, 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 six months ended June 30,
2020 and highlighted recent corporate updates.
Recent Corporate Updates
Pain Management Franchise
- Positive CHMP Opinion Received for ZYNRELEF™ for the
Management of Postoperative Pain: In July 2020, the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion, recommending the granting of a marketing
authorisation for ZYNRELEF (formerly known as HTX-011),
intended for the treatment of postoperative pain. The CHMP's
positive opinion will now be reviewed by the European Commission
(EC), with a final decision on the Marketing Authorisation
Application expected in the coming months. An EC marketing
authorisation through the centralized procedure is valid in all 27
European Union (EU) member countries as well as the European
Economic Area countries. The CHMP recommended that ZYNRELEF be
indicated for treatment of somatic postoperative pain from small-
to medium-sized surgical wounds in adults.
- Complete Response Letter Received from the FDA Regarding the
NDA for HTX-011 for the Management of Postoperative
Pain: In June 2020, Heron
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding the New Drug Application (NDA)
for HTX-011. The CRL stated that the FDA is unable to approve the
NDA in its present form based on the need for additional
non-clinical information. Based on the complete review of the NDA,
the FDA did not identify any clinical safety or efficacy issues or
chemistry, manufacturing and controls (CMC) issues. There are four
non-clinical issues in the CRL, none of which relate to any
observed toxicity. Three relate to confirming exposure of
excipients in preclinical reproductive toxicology studies, and the
fourth relates to changing the manufacturing release specification
of the allowable level of an impurity based on animal toxicology
coverage. We do not believe that any of the issues are significant
barriers to ultimate approval, as all of the excipients have
extensive histories of use in pharmaceuticals and the specification
can be revised.
- Initiation of Phase 1b/2
Clinical Study of HTX-034 for the Treatment of Postoperative
Pain: In May 2020,
Heron initiated a Phase 1b/2 clinical
study in patients undergoing bunionectomy of HTX-034, Heron's
next-generation product for the treatment of postoperative pain.
The study initiation followed clearance from the FDA of Heron's
Investigational New Drug (IND) application for HTX-034 for the
treatment of postoperative pain.
CINV Franchise
- Initiation of Phase 2 Clinical Study of CINVANTI®
for the Treatment of COVID-19: In July 2020, Heron initiated the GUARDS-1 Study, a
Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable
emulsion in early hospitalized patients with Coronavirus Disease
2019 (COVID-19). The study initiation followed clearance from the
FDA of Heron's IND application for CINVANTI for the treatment of
COVID-19.
- CINV Net Product Sales: For the three and six
months ended June 30, 2020,
chemotherapy–induced nausea and vomiting (CINV) franchise net
product sales were $22.7 million and
$48.1 million, respectively, compared
to $36.7 million and $68.3 million, respectively, for the same periods
in 2019.
-
- CINVANTI Net Product Sales: Net product sales of
CINVANTI for the three and six months ended June 30, 2020 were $22.6
million and $47.8 million,
respectively, compared to $33.2
million and $61.2 million,
respectively, for the same periods 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 and six months ended
June 30, 2020 were $0.1 million and $0.3
million, respectively, compared to $3.5 million and $7.1
million, respectively, for the same periods 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: Although Heron
anticipates a decrease in new diagnoses and chemotherapy patient
starts because of the onging COVID-19 pandemic, the Company is
maintaining its 2020 guidance for net product sales for the CINV
franchise of $70 million to
$80 million.
"We are pleased with the CHMP's recent positive opinion for
ZYNRELEF in the EU, and we remain committed to bringing this
important non-opioid analgesic to patients in the U.S. as soon as
possible. We have submitted a request for a Type A meeting with the
FDA and look forward to working with the FDA to achieve this goal,"
said Barry Quart, Pharm.D., President and Chief Executive Officer
of Heron. "In our CINV franchise, we are encouraged by the
continued performance of CINVANTI during both a generic arbitrage
period and the COVID-19 pandemic and are maintaining our 2020 net
product sales guidance of $70 million
to $80 million."
Financial Results
Net product sales for the three and six months ended
June 30, 2020 were $22.7 million and $48.1
million, respectively, compared to $36.7 million and $68.3
million, respectively, for the same periods in 2019.
Heron's net loss for the three and six months ended June 30, 2020 was $55.2
million and $106.8 million, or
$0.61 per share and $1.18 per share, respectively, compared to
$50.2 million and $113.2 million, or $0.63 per share and $1.43 per share, respectively, for the same
periods in 2019. Net loss for the three and six months ended
June 30, 2020 included non-cash,
stock-based compensation expense of $11.1
million and $23.1 million,
respectively, compared to $12.7
million and $30.6 million,
respectively, for the same periods in 2019.
As of June 30, 2020, Heron had cash, cash equivalents and
short-term investments of $300.8 million, compared to
$391.0 million as of December 31, 2019. Net cash used for operating
activities for the six months ended June 30,
2020 was $90.2 million,
compared to $72.1 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 (ZYNRELEF in the European Union) for
Postoperative Pain
HTX-011 (ZYNRELEF in the European Union), an investigational
non-opioid analgesic, 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 2018 and
received Priority Review designation in December 2018. A complete response letter (CRL)
was received from the FDA regarding the NDA for HTX-011 on
June 26, 2020 relating to
non–clinical information. No clinical safety or efficacy issues and
no chemistry, manufacturing and controls (CMC) issues were
identified. The European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
for ZYNRELEF in July 2020. 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. Heron is working to
respond to a list of questions received from Health Canada in
July 2020.
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.
CINVANTI is under investigation for the treatment of COVID-19 as
a daily 2-minute IV injection when added to the current standard of
care.
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 HTX-034 for Postoperative Pain
HTX-034, an investigational non-opioid, is a fixed-dose
combination, extended–release solution of the local anesthetic
bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam
and an additional agent that further potentiates the activity
of bupivacaine. HTX-034 is formulated in the same proprietary
polymer as HTX-011. By combining two different mechanisms that each
enhance the activity of the local anesthetic bupivacaine, HTX-034
is designed to provide superior and prolonged analgesia. Local
administration of HTX-034 in a validated preclinical postoperative
pain model resulted in sustained analgesia for 7 days.
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 in the U.S.; the timing of the European Commission's
(EC) review process for ZYNRELEF; whether
the EC authorizes the Marketing Authorisation
Application for ZYNRELEF; the timing of the commercial launch
of ZYNRELEF in Europe; the timing
of Health Canada's 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; the extent of the impact of the
ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our
business; 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)
|
|
|
|
|
|
June
30,
2020
|
|
December
31,
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
80,728
|
|
$
|
71,898
|
|
|
Short-term
investments
|
|
|
220,114
|
|
|
319,074
|
|
|
Accounts receivable,
net
|
|
|
37,502
|
|
|
39,879
|
|
|
Inventory
|
|
|
41,442
|
|
|
24,968
|
|
|
Prepaid expenses and
other current assets
|
|
|
13,109
|
|
|
23,245
|
|
|
Total current
assets
|
|
|
392,895
|
|
|
479,064
|
|
|
Property and
equipment, net
|
|
|
21,886
|
|
|
19,618
|
|
|
Right-of-use lease
assets
|
|
|
17,594
|
|
|
13,754
|
|
|
Other
assets
|
|
|
346
|
|
|
346
|
|
|
Total
assets
|
|
$
|
432,721
|
|
$
|
512,782
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
18,458
|
|
$
|
2,758
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
30,173
|
|
|
34,614
|
|
|
Accrued payroll and
employee liabilities
|
|
|
11,193
|
|
|
15,248
|
|
|
Other accrued
liabilities
|
|
|
23,728
|
|
|
36,535
|
|
|
Current lease
liabilities
|
|
|
2,830
|
|
|
1,926
|
|
|
Convertible notes
payable to related parties, net of discount
|
|
|
6,269
|
|
|
5,624
|
|
|
Total current
liabilities
|
|
|
92,651
|
|
|
96,705
|
|
|
Non-current lease
liabilities
|
|
|
16,012
|
|
|
12,242
|
|
|
Total
liabilities
|
|
|
108,663
|
|
|
108,947
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
908
|
|
|
903
|
|
|
Additional paid-in
capital
|
|
|
1,594,436
|
|
|
1,568,317
|
|
|
Accumulated other
comprehensive income
|
|
|
953
|
|
|
85
|
|
|
Accumulated
deficit
|
|
|
(1,272,239)
|
|
|
(1,165,470)
|
|
|
Total stockholders'
equity
|
|
|
324,058
|
|
|
403,835
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
432,721
|
|
$
|
512,782
|
|
|
|
|
|
|
|
|
|
|
HERON
THERAPEUTICS, INC.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
Three Months
Ended
June
30,
|
|
Six Months Ended
June
30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product sales
|
$ 22,668
|
|
$
36,659
|
|
$
48,068
|
|
$
68,261
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product sales
|
9,005
|
|
13,588
|
|
19,627
|
|
28,550
|
|
Research and development
|
44,004
|
|
41,425
|
|
80,898
|
|
84,397
|
|
General and administrative
|
9,819
|
|
9,778
|
|
20,241
|
|
19,426
|
|
Sales and marketing
|
15,589
|
|
23,647
|
|
35,785
|
|
52,367
|
|
Total operating expenses
|
78,417
|
|
88,438
|
|
156,551
|
|
184,740
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(55,749)
|
|
(51,779)
|
|
(108,483)
|
|
(116,479)
|
|
|
|
|
|
|
|
|
|
Other income,
net
|
559
|
|
1,557
|
|
1,714
|
|
3,245
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(55,190)
|
|
$
(50,222)
|
|
$
(106,769)
|
|
$
(113,234)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.61)
|
|
$
(0.63)
|
|
$
(1.18)
|
|
$
(1.43)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
90,753
|
|
79,548
|
|
90,581
|
|
78,987
|
|
HERON
THERAPEUTICS, INC.
Consolidated
Statements of Cash Flows
(In
thousands)
|
|
|
|
|
|
|
|
|
Six Months
Ended
June
30,
|
|
|
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
(Unaudited)
|
|
|
Operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(106,769)
|
|
|
$
|
(113,234)
|
|
|
Adjustments to
reconcile net loss to net cash used for operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
|
|
23,088
|
|
|
|
30,608
|
|
|
Depreciation and
amortization
|
|
|
|
|
1,366
|
|
|
|
959
|
|
|
Amortization of debt
discount
|
|
|
|
|
645
|
|
|
|
507
|
|
|
Realized gain on
available-for-sale securities
|
|
|
|
|
—
|
|
|
|
(8)
|
|
|
Accretion of discount
on short-term investments
|
|
|
|
|
(82)
|
|
|
|
(2,437)
|
|
|
Impairment of property
and equipment
|
|
|
|
|
53
|
|
|
|
54
|
|
|
Loss on disposal of
property and equipment
|
|
|
|
|
—
|
|
|
|
53
|
|
|
Change in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
|
2,377
|
|
|
|
(2,169)
|
|
|
Inventory
|
|
|
|
|
(16,474)
|
|
|
|
9,762
|
|
|
Prepaid expenses and
other assets
|
|
|
|
|
10,136
|
|
|
|
2,454
|
|
|
Accounts
payable
|
|
|
|
|
15,700
|
|
|
|
(8,866)
|
|
|
Accrued clinical and
manufacturing liabilities
|
|
|
|
|
(4,441)
|
|
|
|
913
|
|
|
Accrued payroll and
employee liabilities
|
|
|
|
|
(4,055)
|
|
|
|
(4,415)
|
|
|
Other accrued
liabilities
|
|
|
|
|
(11,756)
|
|
|
|
13,687
|
|
|
Net cash used for
operating activities
|
|
|
|
|
(90,212)
|
|
|
|
(72,132)
|
|
|
Investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of
short-term investments
|
|
|
|
|
(66,915)
|
|
|
|
(204,358)
|
|
|
Maturities and sales
of short-term investments
|
|
|
|
|
166,825
|
|
|
|
284,606
|
|
|
Purchases of property
and equipment
|
|
|
|
|
(3,687)
|
|
|
|
(4,299)
|
|
|
Net cash provided by
investing activities
|
|
|
|
|
96,223
|
|
|
|
75,949
|
|
|
Financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from stock
option exercises
|
|
|
|
|
1,309
|
|
|
|
16,215
|
|
|
Proceeds from
purchases under Employee Stock Purchase Plan
|
|
|
|
|
1,507
|
|
|
|
1,170
|
|
|
Proceeds from warrant
exercises
|
|
|
|
|
3
|
|
|
|
—
|
|
|
Net cash provided by
financing activities
|
|
|
|
|
2,819
|
|
|
|
17,385
|
|
|
Net increase in cash
and cash equivalents
|
|
|
|
|
8,830
|
|
|
|
21,202
|
|
|
Cash and cash
equivalents at beginning of year
|
|
|
|
|
71,898
|
|
|
|
31,836
|
|
|
Cash and cash
equivalents at end of period
|
|
|
|
$
|
80,728
|
|
|
$
|
53,038
|
|
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-six-months-ended--june-30-2020-and-highlights-recent-corporate-updates-301106977.html
SOURCE Heron Therapeutics, Inc.