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Heron Therapeutics Announces Financial Results for the Three and Six Months Ended

Key Takeaway: Heron Therapeutics Announces Financial Results for the Three and Six Months Ended June 30, 2018 and Recent Corporate Progress SAN DIEGO, Calif. (BUSINESS WIRE) August 8, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving

Full Press Release Details

Heron Therapeutics Announces Financial Results for the Three and Six Months
Ended June 30, 2018 and Recent Corporate Progress
SAN DIEGO, Calif. (BUSINESS WIRE) August 8, 2018 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 reported financial results for
the three and six months ended June 30, 2018 and highlighted recent corporate progress.
Recent Corporate Progress
Pain Management Franchise
In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.
We are pleased with the progress we have made in the first half of 2018. In our pain
management franchise, the results of completed Phase 2 and Phase 3 studies and the Breakthrough Therapy designation by the FDA of HTX-011 further confirm our belief in the superiority of HTX-011 over the standard of care in reducing pain intensity and opioid use across multiple diverse surgical models. In our CINV franchise, providers are continuing to realize the value of CINVANTI over other
injectable NK1 receptor antagonists, and the number of oncology clinics ordering CINVANTI has increased, said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics.
We look forward to submitting an NDA for HTX-011 to the FDA in the second half of this year and achieving full-year CINV net product sales in the upper end of our $60 million to $70 million
for the three and six months ended June 30, 2018 were $17.3 million and $28.8 million, respectively, compared to $8.5 million and $12.1 million for the same periods in 2017, respectively.
Heron s net loss for the three and six months ended June 30, 2018 was $38.7 million and $90.9 million, or $0.54 per share and $1.33 per
share, respectively, compared to $42.8 million and $93.1 million, or $0.80 per share and $1.79 per share, for the same periods in 2017, respectively. Net loss for the three and six months ended June 30, 2018, included non-cash, stock-based compensation expense of $7.8 million and $15.5 million, respectively, compared to $8.2 million and $16.2 million, for the same periods in 2017, respectively.
As of June 30, 2018, Heron had cash, cash equivalents and short-term investments
of $423.0 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the six months ended June 30, 2018 was $122.4 million, compared to $82.6 million for the same
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 alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from FDA in the
fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.
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 intravenous
formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly
deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent
NK1 receptor antagonist 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 receptor antagonist 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. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood
vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.
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 cancer or pain.
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 2018 net product sales guidance for the CINV franchise; the timing of the HTX-011 NDA filing and review process; 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
except per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Revenues:
Net product sales $ 17,277 $ 8,510 $ 28,844 $ 12,142
Operating expenses:
Cost of product sales 5,231 1,013 8,364 2,199
Research and development 30,159 28,597 69,720 61,981
General and administrative 6,209 6,185 13,237 12,927
Sales and marketing 14,531 14,770 28,366 26,389
Total operating expenses 56,130 50,565 119,687 103,496
Loss from operations (38,853 ) (42,055 ) (90,843 ) (91,354 )
Other income (expense), net 183 (744 ) (92 ) (1,774 )
Net loss $ (38,670 ) $ (42,799 ) $ (90,935 ) $ (93,128 )
Basic and diluted net loss per share $ (0.54 ) $ (0.80 ) $ (1.33 ) $ (1.79 )
Shares used in computing basic and diluted net loss per share 71,952 53,791 68,358 52,170
HERON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
June 30, 2018 December 31, 2017
(unaudited)
Cash, cash equivalents and short-term investments $ 422,964 $ 172,379
Accounts receivable, net 45,886 41,874
Total assets 510,556 234,307
Promissory note payable 25,000 25,000
Total stockholders equity 431,891 131,136
Investor Relations and Media Contact:
Senior VP, General Counsel, Business
Development and Corporate Secretary
Heron Therapeutics, Inc.
Last updated: Aug 8, 2018