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Heron Therapeutics Announces Financial Results for the Three Months Ended

Key Takeaway: Heron Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019 and Highlights Recent Corporate Progress SAN DIEGO, Calif. (BUSINESS WIRE) May 9, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improvin

Full Press Release Details

Heron Therapeutics Announces Financial Results for the Three Months Ended
March 31, 2019 and Highlights Recent Corporate Progress
SAN DIEGO, Calif. (BUSINESS WIRE) May 9, 2019 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, 2019 and highlighted recent corporate progress.
Recent Corporate Progress
Pain Management Franchise
We are focused on resubmitting
the NDA for HTX-011 as soon as possible to bring this important medicine to market to help patients manage their postoperative pain without the need for opioids, said Barry Quart, Pharm.D.,
President and Chief Executive Officer of Heron. Our CINV franchise remains strong, highlighted by our strong net product sales in the first quarter and our label expansion for CINVANTI for IV push.
Net product sales for the three months
ended March 31, 2019 were $31.6 million compared to $11.6 million for the same period in 2018.
Heron s net loss for the three months
ended March 31, 2019 was $63.0 million, or $0.80 per share, compared to $52.3 million, or $0.81 per share for the same period in 2018. Net loss for the three months ended March 31, 2019 included
non-cash, stock-based compensation expense of $17.9 million compared to $7.7 million for the same period in 2018.
As of March 31, 2019, Heron had cash, cash equivalents and short-term investments
of $289.2 million, compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the three months ended March 31, 2019 was $49.0 million compared to $61.7 million for the same
Heron expects to end the year with more than $190 million in cash, cash equivalents and short-term investments.
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron s proprietary Biochronomer
drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering
sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for
systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or
bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA
in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review
designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to CMC and non-clinical information. No
issues related to clinical efficacy or safety were noted. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.
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, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). 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). CINVANTI is the only IV formulation of an NK1 RA indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic
surfactant. The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion or a 2-minute 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: the full-year 2019 net product sales guidance for the CINV franchise; whether the
FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011; the timing of the CHMP s review process for
HTX-011; whether the European Commission authorizes the MAA 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.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended March 31,
2019 2018
(unaudited)
Revenues:
Net product sales $ 31,602 $ 11,567
Operating expenses:
Cost of product sales 14,962 3,133
Research and development 42,972 39,561
General and administrative 9,648 7,028
Sales and marketing 28,720 13,835
Total operating expenses 96,302 63,557
Loss from operations (64,700 ) (51,990 )
Other income (expense), net 1,688 (275 )
Net loss $ (63,012 ) $ (52,265 )
Basic and diluted net loss per share $ (0.80 ) $ (0.81 )
Shares used in computing basic and diluted net loss per share 78,419 64,724
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
March 31, 2019 December 31, 2018
(unaudited)
Cash, cash equivalents and short-term investments $ 289,238 $ 332,371
Accounts receivable, net 74,007 64,652
Total assets 435,794 462,179
Total stockholders equity 331,814 370,160
Investor Relations and Media Contact:
Senior VP, General Counsel, Business
Development and Corporate Secretary
Heron Therapeutics, Inc.
Last updated: May 9, 2019