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Heron Therapeutics Announces Financial Results for the Three and Nine Months Ended September 30, 2019 and Highlights Recent Corporate Updates

November 12, 2019 GMT

SAN DIEGO, Nov. 12, 2019 /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 nine months ended September 30, 2019 and highlighted recent corporate updates.

Recent Corporate Updates

Pain Management Franchise

CINV Franchise

“We are pleased with the advances made during the third quarter of 2019 in both our pain management and CINV franchises, highlighted by the FDA acceptance of our recent NDA resubmission for HTX-011 and strong net product sales for our CINV franchise, even amid the launch of generic fosaprepitant,” said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. “We look forward to continuing our commercial momentum with the launch of HTX-011 for postoperative pain management in the second quarter of 2020, pending FDA approval.”

Financial Results

Net product sales for the three and nine months ended September 30, 2019 were $42.6 million and $110.9 million, respectively, compared to $19.8 million and $48.6 million, respectively, for the same periods in 2018.

Heron’s net loss for the three and nine months ended September 30, 2019 was $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, compared to $38.3 million and $129.3 million, or $0.49 per share and $1.81 per share, respectively, for the same periods in 2018. Net loss for the three and nine months ended September 30, 2019 included non-cash, stock-based compensation expense of $9.7 million and $40.3 million, respectively, compared to $8.1 million and $23.6 million, respectively, for the same periods in 2018.

As of September 30, 2019, Heron had cash, cash equivalents and short-term investments of $256.3 million. Adjusting for net proceeds of $162.2 million from our October 2019 public offering of common stock, Heron had pro-forma cash, cash equivalents and short-term investments of $418.5 million. This compares to $332.4 million in cash, cash equivalents and short-term investments as of December 31, 2018. Net cash used for operating activities for the nine months ended September 30, 2019 was $97.6 million, compared to $158.3 million for the same period in 2018.

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, and the FDA set a PDUFA goal date of March 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.

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 HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 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: 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)

(unaudited)



Three Months Ended

September 30,


Nine Months Ended

September 30,


2019


2018


2019


2018









Revenues:








Net product sales

$ 42,624


$ 19,786


$ 110,885


$ 48,630

Operating expenses:








Cost of product sales

17,195


7,576


45,745


15,940

Research and development

34,708


30,421


119,105


100,141

General and administrative

8,597


7,288


28,023


20,525

Sales and marketing

16,977


16,281


69,344


44,647

Total operating expenses

77,477


61,566


262,217


181,253









Loss from operations

(34,853)


(41,780)


(151,332)


(132,623)









Other income, net

1,258


3,434


4,503


3,342









Net loss

$ (33,595)


$ (38,346)


$ (146,829)


$ (129,281)









Basic and diluted net loss per share

$ (0.42)


$ (0.49)


$ (1.85)


$ (1.81)









Shares used in computing basic and
diluted net loss per share

79,940


77,811


79,308


71,544

HERON THERAPEUTICS, INC.

Condensed Consolidated Balance Sheet Data

(in thousands)



September 30,


December 31,

2019


2018


(unaudited)



Cash, cash equivalents and short-term investments

$ 256,278


$ 332,371

Accounts receivable, net

66,955


64,652

Total assets

392,962


462,179

Total stockholders' equity

285,442


370,160





Investor Relations and Media Contact:
David Szekeres
Senior VP, General Counsel, Business Development and Corporate Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447

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SOURCE Heron Therapeutics, Inc.