Heron Therapeutics Announces Financial Results for the Three and Nine Months Ended September 30, 2020 and Highlights Recent Corporate Updates

 

SAN DIEGO, Nov. 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 nine months ended September 30, 2020 and highlighted recent corporate updates.

Recent Corporate Updates

Pain Management Franchise

  • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's positive opinion from the Committee for Medicinal Products for Human Use in July 2020. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union (EU), and the other countries in the European Economic Area (EEA). We are currently assessing the evolving global environment for pharmaceuticals and developing a coordinated global marketing strategy, and at this time we anticipate making ZYNRELEF available to patients in Europe during the second half of 2021.
     
  • Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain: In September 2020, we announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for Heron to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of 2020.

CINV Franchise

  • CINV Net Product Sales: For the three and nine months ended September 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

     
    • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2020 were $19.8 million and $67.6 million, respectively, compared to $36.4 million and $97.6 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 nine months ended September 30, 2020 were $0.2 million and $0.4 million, respectively, compared to $6.2 million and $13.3 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 ongoing COVID-19 pandemic (COVID-19), the Company has increased its 2020 guidance for net product sales for the CINV franchise from a range of $70 million to $80 million to net product sales of $85 million.

"The third quarter was highlighted by the authorization of ZYNRELEF in the EU and we remain focused on resubmitting the New Drug Application for HTX-011 in the U.S. as quickly as possible in order to bring this innovative non-opioid medicine to patients suffering from postoperative pain," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In addition, our CINV franchise is advancing well, with continued strong performance of CINVANTI against a backdrop of arbitrage and the ongoing global pandemic. Based on the strong commercial execution, we are very pleased to increase our guidance for 2020 to $85 million in net product sales."

Financial Results

Net product sales for the three and nine months ended September 30, 2020 were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

Heron's net loss for the three and nine months ended September 30, 2020 was $58.2 million and $165.0 million, or $0.64 per share and $1.82 per share, respectively, compared to $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, for the same periods in 2019. Net loss for the three and nine months ended September 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $34.2 million, respectively, compared to $9.7 million and $40.3 million, respectively, for the same periods in 2019.

As of September 30, 2020, Heron had cash, cash equivalents and short-term investments of $258.1 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the nine months ended September 30, 2020 was $132.3 million, compared to $97.6 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 for Postoperative Pain (ZYNRELEF in the EU and EEA)

HTX-011, 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. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the EC granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the EU, and the other countries in the EEA.

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 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 timing of the NDA resubmission to the FDA; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; 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 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.

Condensed Consolidated Balance Sheets

(In thousands)

 
   

September 30,

2020

 

December 31,

2019

   

(Unaudited)

   

ASSETS

           

Current assets:

           

Cash and cash equivalents

 

$

95,141

 

$

71,898

Short-term investments

   

163,005

   

319,074

Accounts receivable, net

   

33,654

   

39,879

Inventory

   

42,749

   

24,968

Prepaid expenses and other current assets

   

16,446

   

23,245

Total current assets

   

350,995

   

479,064

Property and equipment, net

   

21,741

   

19,618

Right-of-use lease assets

   

16,941

   

13,754

Other assets

   

346

   

346

Total assets

 

$

390,023

 

$

512,782

LIABILITIES AND STOCKHOLDERS' EQUITY

           

Current liabilities:

           

Accounts payable

 

$

12,067

 

$

2,758

Accrued clinical and manufacturing liabilities

   

40,718

   

34,614

Accrued payroll and employee liabilities

   

13,235

   

15,248

Other accrued liabilities

   

22,009

   

36,535

Current lease liabilities

   

2,912

   

1,926

Convertible notes payable to related parties, net of discount

   

6,637

   

5,624

Total current liabilities

   

97,578

   

96,705

Non-current lease liabilities

   

15,298

   

12,242

Total liabilities

   

112,876

   

108,947

Stockholders' equity:

           

Common stock

   

909

   

903

Additional paid-in capital

   

1,606,165

   

1,568,317

Accumulated other comprehensive income

   

540

   

85

Accumulated deficit

   

(1,330,467)

   

(1,165,470)

Total stockholders' equity

   

277,147

   

403,835

Total liabilities and stockholders' equity

 

$

390,023

 

$

512,782

 

HERON THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

 
   

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

   

2020

 

2019

 

2020

 

2019

   

(unaudited)

Revenues:

                       

Net product sales

 

$

19,965

 

$

42,624

 

$

68,033

 

$

110,885

Operating expenses:

                       

Cost of product sales

   

7,170

   

17,195

   

26,797

   

45,745

Research and development

   

49,182

   

34,708

   

130,080

   

119,105

General and administrative

   

9,482

   

8,597

   

29,723

   

28,023

Sales and marketing

   

12,515

   

16,977

   

48,300

   

69,344

Total operating expenses

   

78,349

   

77,477

   

234,900

   

262,217

Loss from operations

   

(58,384)

   

(34,853)

   

(166,867)

   

(151,332)

Other income, net

   

156

   

1,258

   

1,870

   

4,503

Net loss

 

$

(58,228)

 

$

(33,595)

 

$

(164,997)

 

$

(146,829)

                         

Basic and diluted net loss per share

 

$

(0.64)

 

$

(0.42)

 

$

(1.82)

 

$

(1.85)

                         

Shares used in computing basic and diluted net loss per share

   

90,849

   

79,940

   

90,671

   

79,308

 

HERON THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

 
   

Nine Months Ended

September 30,

   

2020

 

2019

   

(unaudited)

Operating activities:

           

Net loss

 

$

(164,997)

 

$

(146,829)

Adjustments to reconcile net loss to net cash used for operating activities:

           

Stock-based compensation expense

   

34,183

   

40,312

Depreciation and amortization

   

2,135

   

1,480

Amortization of debt discount

   

1,013

   

780

Realized gain on available-for-sale securities

   

   

(8)

Amortization of premium (accretion of discount) on short-term investments

   

39

   

(3,264)

Impairment of property and equipment

   

61

   

80

Loss on disposal of property and equipment

   

   

53

Change in operating assets and liabilities:

           

Accounts receivable

   

6,225

   

(2,303)

Inventory

   

(17,781)

   

14,860

Prepaid expenses and other assets

   

6,799

   

(5,549)

Accounts payable

   

9,309

   

(15,236)

Accrued clinical and manufacturing liabilities

   

6,104

   

1,603

Accrued payroll and employee liabilities

   

(2,013)

   

(3,263)

Other accrued liabilities

   

(13,343)

   

19,681

Net cash used for operating activities

   

(132,266)

   

(97,603)

Investing activities:

           

Purchases of short-term investments

   

(92,040)

   

(287,579)

Maturities and sales of short-term investments

   

248,525

   

395,406

Purchases of property and equipment

   

(4,319)

   

(3,251)

Net cash provided by investing activities

   

152,166

   

104,576

Financing activities:

           

Net proceeds from sale of common stock

   

   

(110)

Proceeds from stock option exercises

   

1,833

   

20,239

Proceeds from purchases under the Employee Stock Purchase Plan

   

1,507

   

1,170

Proceeds from warrant exercises

   

3

   

Net cash provided by financing activities

   

3,343

   

21,299

Net increase in cash and cash equivalents

   

23,243

   

28,272

Cash and cash equivalents at beginning of year

   

71,898

   

31,836

Cash and cash equivalents at end of period

 

$

95,141

 

$

60,108

Investor Relations and Media Contact:
David Szekeres
EVP, Chief Operating Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com 
858-251-4447

Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-and-nine-months-ended--september-30-2020-and-highlights-recent-corporate-updates-301166525.html

SOURCE Heron Therapeutics, Inc.

 
 
Company Codes: NASDAQ-SMALL:HRTX
 

Back to news