HRTX Heron Therapeutics Inc.

13.55
-0.3  -2%
Previous Close 13.85
Open 13.58
52 Week Low 12.52
52 Week High 22.4
Market Cap $1,379,783,844
Shares 101,829,066
Float 89,006,422
Enterprise Value $1,268,292,564
Volume 2,284,905
Av. Daily Volume 1,507,376
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Upcoming Catalysts

Drug Stage Catalyst Date
HTX-019
Ppostoperative nausea and vomiting (PONV)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
ZYNRELEF (HTX-011)
Post operative pain
Approved
Approved
FDA approval announced May 13, 2021.
HTX-034
Postoperative Pain
Phase 1/2
Phase 1/2
Phase 2 portion of trial initiated March 2021.
CINVANTI (aprepitant) - (GUARDS-1)
COVID-19
Phase 2
Phase 2
Phase 2 initiation announced July 16, 2020.
HTX-011
Total knee arthroplasty
Phase 3
Phase 3
Phase 3b data released October 3, 2019.
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
FDA additional approval allowing IV injection in addition to current IV infusion.
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
CRL Mar 28 2013. Approved August 10 2016.

Latest News

  1. SAN DIEGO, May 13, 2021 /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 that the U.S. Food and Drug Administration (FDA) has approved ZYNRELEF (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and…

    SAN DIEGO, May 13, 2021 /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 that the U.S. Food and Drug Administration (FDA) has approved ZYNRELEF (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. The synergy between bupivacaine and meloxicam in ZYNRELEF has resulted in patients experiencing significantly less pain, including severe pain, and significantly more patients requiring no opioids (opioid-free) after surgery as compared to bupivacaine solution, the current standard-of-care. 

    "The approval of ZYNRELEF marks an exciting milestone for patients, healthcare providers and pain management. Not just because it can reduce postoperative pain for up to 72 hours, but because for many patients it can eliminate the need for opioids after surgery," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We are in a strong position to launch ZYNRELEF, given our highly successful hospital launch of CINVANTI and our pricing and unprecedented value proposition, which will ensure broad access for patients and healthcare providers. Our existing commercial team will immediately begin working with current accounts to gain formulary access, with full commercial availability expected by July 2021."

    ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution. ZYNRELEF demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids, with more patients opioid-free compared to bupivacaine solution. Clinical studies included over 1,000 patients, with the most common adverse reactions following ZYNRELEF administration being constipation, vomiting, and headache.

    "The first three days after surgery are when patients experience the most severe postsurgical pain and are most likely to receive opioids to manage that pain. With the impressive reduction in pain and opioid use demonstrated by ZYNRELEF, we now have an important new option to help many patients achieve an opioid-free recovery," said Roy G. Soto, M.D., anesthesiologist at Beaumont Health System. "The dramatic increase in opioid-related deaths last year highlights the significant need for safe, effective and non-addictive options to manage pain that decrease opioid exposure and reduce the need for opioid prescriptions after surgery."

    "Approximately 50 million Americans undergo surgery annually, and up to 67 percent of those patients receive opioids," said Alan Rechter, M.D., Orthopaedic Surgeon at Orthopaedic Associates LLP. "Inadequate postoperative pain management has been associated with poor patient outcomes, causing a substantial burden on public health and contributing to recovery delays. Through today's approval of ZYNRELEF, we now have a new therapy to offer patients, with the potential to meaningfully impact the postoperative pain management landscape and reduce, and even eliminate, unnecessary exposure to opioids in many patients."

    Conference Call and Webcast

    Heron will host a conference call and webcast on May 13, 2021 at 8:30 am ET. The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 3922347 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron's website for 60 days following the call.

    Important Safety Information for Patients

    ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

    • can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
    • cannot be used during heart bypass surgery.
    • can increase the risk of gastrointestinal bleeding, ulcers, and tears.

    ZYNRELEF should also not be used if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines; or as a paracervical block, during childbirth.

    The most common side effects of ZYNRELEF are constipation, vomiting, and headache.

    The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Please see full Prescribing Information, including Boxed Warning.

    About ZYNRELEFTM for Postoperative Pain

    ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. 

    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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. 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, the timing of the commercial launch of ZYNRELEF in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and Europe; the extent of the impact of the ongoing Coronavirus Disease 2019 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.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

     

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-us-fda-approval-of-zynrelef-htx-011-for-the-management-of-postoperative-pain-for-up-to-72-hours-301290467.html

    SOURCE Heron Therapeutics, Inc.

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  2. SAN DIEGO, May 10, 2021 /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 months ended March 31, 2021 and highlighted recent corporate updates.

    Recent Corporate Updates

    Acute Care Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a PDUFA goal date of May 12,

    SAN DIEGO, May 10, 2021 /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 months ended March 31, 2021 and highlighted recent corporate updates.

    Recent Corporate Updates

    Acute Care Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a PDUFA goal date of May 12, 2021.
    • Initiation of Expanded Phase 2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain: In March 2021, Heron initiated the expanded Phase 2 clinical study in patients undergoing bunionectomy with HTX-034, Heron's next-generation product for the treatment of postoperative pain.
    • NDA for HTX-019 Planned in Late 2021 for Prevention of PONV in Adults: In the Phase 1 bioequivalence study, HTX-019 32 mg as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of postoperative nausea and vomiting (PONV). A 505(b)(2) NDA for HTX-019 for PONV in adults is planned for late 2021.

    Oncology Care Franchise

    • 2021 Net Product Sales: For the three months ended March 31, 2021, oncology care franchise net product sales were $20.0 million, compared to $25.4 million for the same period in 2020. The Coronavirus Disease 2019 (COVID-19) pandemic reduced cancer screening procedures and new patient treatment starts in 2020 resulting in fewer clinic anti-emetic administrations during the first quarter of 2021 compared to the prior year and last quarter. Heron is assisting Community Oncology Alliance with its campaign to get patients back into screening. With the greater availability of COVID-19 vaccines and the declining rates of infection, Heron believes that the number of patients receiving cancer treatment will begin to return to normal levels.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2021 were $18.5 million, compared to $25.2 million for the same period in 2020. Based on recently signed agreements with key customers, Heron believes the most significant impact of the generic arbitrage is over and expects to grow CINVANTI market share in 2021 and beyond.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2021 were $1.5 million, compared to $0.2 million for the same period in 2020. In the first quarter of 2021, Heron reinstated promotion and contracting of SUSTOL to restore growth in 2021 and beyond.
    • Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the oncology care franchise of $130 million to $145 million.

    "We have no outstanding questions on the pending NDA and are currently in labelling discussions with the FDA, as we prepare for the anticipated commercial launch of HTX-011 in the U.S.," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "For the oncology care franchise, we expect the market to pick up in the second quarter and we recently signed a large, multi-year contract for CINVANTI that will help increase net product sales throughout 2021."

    Financial Results

    Net product sales for the three months ended March 31, 2021 were $20.0 million, compared to $25.4 million for the same period in 2020.

    Heron's net loss for the three months ended March 31, 2021 was $52.6 million, or $0.58 per share, compared to $51.6 million, or $0.57 per share for the same period in 2020. Net loss for the three months ended March 31, 2021 included non-cash, stock-based compensation expense of $11.5 million, compared to $12.0 million for the same period in 2020.

    As of March 31, 2021, Heron had cash, cash equivalents and short-term investments of $166.5 million, compared to $208.5 million as of December 31, 2020. Net cash used for operating activities for the three months ended March 31, 2021 was $41.9 million, compared to $32.9 million for the same period in 2020. 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 Europe)

    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 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 resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a PDUFA goal date of May 12, 2021. In September 2020, the European Commission 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. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid analgesic, is a triple-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, 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 HTX-019 for PONV

    HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND® (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg.

    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, 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 U.S. 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-hydroxytryptamine type 3 RA 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients. 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 FDA approves the NDA for HTX-011; whether the scope of the label for HTX-011, if approved, will be as desired; the timing of the commercial launch of HTX-011 in the U.S., if approved; the timing and results of studies for the HTX-034 and HTX-019 development programs; the full-year 2021 net product sales guidance for the oncology care 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.

    Consolidated Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended







    March 31,







    2021





    2020







    (Unaudited)



    Revenues:

















    Net product sales



    $

    20,018





    $

    25,400



    Operating expenses:

















    Cost of product sales





    9,207







    10,622



    Research and development





    38,116







    36,894



    General and administrative





    9,573







    10,422



    Sales and marketing





    15,236







    20,196



    Total operating expenses





    72,132







    78,134



    Loss from operations





    (52,114)







    (52,734)



    Other income (expense)





    (500)







    1,155



    Net loss



    $

    (52,614)





    $

    (51,579)



    Basic and diluted net loss per share



    $

    (0.58)





    $

    (0.57)



    Shares used in computing basic and diluted net

       loss per share





    91,388







    90,409



     

    Heron Therapeutics, Inc.

    Consolidated Balance Sheets

    (in thousands)







    March 31,

    2021



    December 31,

    2020





    (unaudited)





    ASSETS









    Current assets:









    Cash and cash equivalents



    $              59,739



    $            105,138

    Short-term investments



    106,727



    103,353

    Accounts receivable, net



    38,525



    41,850

    Inventory



    42,629



    41,905

    Prepaid expenses and other current assets



    24,668



    21,950

    Total current assets



    272,288



    314,196

    Property and equipment, net



    22,704



    22,737

    Right-of-use lease assets



    15,594



    16,277

    Other assets



    346



    346

    Total assets



    $            310,932



    $            353,556

    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $               1,689



    $                  525

    Accrued clinical and manufacturing liabilities



    54,219



    49,962

    Accrued payroll and employee liabilities



    9,629



    13,597

    Other accrued liabilities



    24,744



    28,369

    Current lease liabilities



    3,081



    2,997

    Convertible notes payable to related parties



    7,555



    7,053

    Total current liabilities



    100,917



    102,503

    Non-current lease liabilities



    13,790



    14,561

    Total liabilities



    114,707



    117,064











    Stockholders' equity:









    Common stock



    914



    913

    Additional paid-in capital



    1,640,552



    1,628,070

    Accumulated other comprehensive income



    121



    257

    Accumulated deficit



    (1,445,362)



    (1,392,748)

    Total stockholders' equity



    196,225



    236,492

    Total liabilities and stockholders' equity



    $            310,932



    $            353,556

     

     

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.



    858-251-4447

     

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-months-ended-march-31-2021-and-highlights-recent-corporate-updates-301287172.html

    SOURCE Heron Therapeutics, Inc.

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  3. SAN DIEGO, Feb. 24, 2021 /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 twelve months ended December 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription…

    SAN DIEGO, Feb. 24, 2021 /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 twelve months ended December 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.
    • 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. As Heron builds large-scale manufacturing capacity to meet the anticipated commercial demand in the U.S. and the rest of the world, we are developing a coordinated global marketing strategy. At this time, Heron anticipates making ZYNRELEF available to patients in Europe during 2022.
    • Low-Dose HTX-034 Produced Greater Pain Reduction Compared to Bupivacaine, the Current Standard-of-Care, Through 96 Hours in Bunionectomy Study: In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled, dose-escalation study in 33 patients undergoing bunionectomy, the reduction in pain intensity observed was greater with the lowest dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus meloxicam and aprepitant) than with the bupivacaine 50 mg solution through 96 hours.
      • In addition, 45.5% of HTX-034 patients remained opioid-free through Day 15 with median opioid consumption of 2.5 mg morphine equivalents (same as one 5 mg oxycodone pill) through 72 hours, a 71% reduction compared to bupivacaine solution.
      • Heron expects to initiate the expanded Phase 2 portion of the study for HTX-034 in the first quarter of 2021.

    CINV Franchise

    • CINV 2020 Net Product Sales: For the three and twelve months ended December 31, 2020, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $20.6 million and $88.6 million, respectively, compared to $35.1 million and $146.0 million for the same periods in 2019.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2020 were $20.3 million and $87.8 million, respectively, compared to $34.6 million and $132.2 million, respectively, for the same periods in 2019. Heron believes the most significant impact of the generic arbitrage is over and expects to grow CINVANTI market share in 2021 and beyond.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2020 were $0.3 million and $0.8 million, respectively, compared to $0.5 million and $13.8 million for the same periods in 2019. On October 1, 2019, we discontinued all discounting of SUSTOL to improve the reimbursement and net selling price of the product, which resulted in significantly lower SUSTOL net product sales in 2020. Heron expects SUSTOL to return to growth in 2021 and beyond.
    • Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the CINV franchise of $130 million to $145 million.

    HTX-019 for PONV

    • HTX-019 Achieved Bioequivalence to Approved Oral Aprepitant 40 mg Dose for Prevention of PONV: A new Investigational New Drug application for HTX-019 (aprepitant injectable emulsion) for postoperative nausea and vomiting (PONV) was approved by the FDA in late September of 2020. In the Phase 1 bioequivalence study, 32 mg of HTX-019 as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of PONV. An NDA for HTX-019 is planned in late 2021 for prevention of PONV in adults.

    Corporate Update

    • Year-End 2020 Cash Balance: Heron ended 2020 with $208.5 million in cash, cash equivalents and short-term investments.

    "We are very pleased that we exceeded our CINV sales guidance for the year, despite 2020 being a challenging year for Heron, with our CINV franchise impacted by both the COVID-19 global pandemic and the EMEND® IV generic arbitrage. We also achieved several important milestones in 2020, including the authorization of ZYNRELEF in Europe and the advancement of HTX-034 for postoperative pain and HTX-019 for PONV into clinical development," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We believe that 2021 will be a transformational year for Heron, with significant growth expected in our CINV products with net product sales guidance of $130 million to $145 million, the anticipated FDA approval and commercial launch of HTX-011 in the U.S., and the submission of an NDA for HTX-019 for PONV in the fourth quarter."                                                         

    Financial Results

    Net product sales for the three and twelve months ended December 31, 2020 were $20.6 million and $88.6 million, respectively, compared to $35.1 million and $146.0 million, respectively, for the same periods in 2019.

    Heron's net loss for the three and twelve months ended December 31, 2020 was $62.3 million and $227.3 million, or $0.68 per share and $2.50 per share, respectively, compared to $57.9 million and $204.7 million, or $0.65 per share and $2.50 per share, respectively, for the same periods in 2019. Net loss for the three and twelve months ended December 31, 2020 included non-cash, stock-based compensation expense of $16.0 million and $50.2 million, respectively, compared to $11.1 million and $51.4 million, respectively, for the same periods in 2019.

    As of December 31, 2020, Heron had cash, cash equivalents and short-term investments of $208.5 million compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the twelve months ended December 31, 2020 was $184.8 million, compared to $124.6 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 Europe)

    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 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 resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a PDUFA goal date of May 12, 2021. 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 European Union, the other countries in the European Economic Area, and the United Kingdom.

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid analgesic, is a triple-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, 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 HTX-019 for Postoperative Nausea and Vomiting

    HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND® (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg.

    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, 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 U.S. 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 RA 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: whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S., if approved; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's New Drug Submission (NDS) review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the timing and results of studies for the HTX-034 and HTX-019 development programs; the full-year 2021 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 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 Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended



    Twelve Months Ended





    December 31,



    December 31,





    2020



    2019



    2020



    2019





    (Unaudited)









    Revenues:

















    Net product sales



    $        20,605



    $        35,083



    $        88,638



    $      145,968

    Operating expenses:

















    Cost of product sales



    9,392



    15,874



    36,189



    61,619

    Research and development



    44,453



    48,277



    174,533



    167,382

    General and administrative



    12,503



    9,874



    42,226



    37,897

    Sales and marketing



    15,553



    20,420



    63,853



    89,764

    Total operating expenses



    81,901



    94,445



    316,801



    356,662

    Loss from operations



    (61,296)



    (59,362)



    (228,163)



    (210,694)

    Other income (expense), net



    (985)



    1,442



    885



    5,945

    Net loss



    $      (62,281)



    $      (57,920)



    $    (227,278)



    $    (204,749)

    Basic and diluted net loss per share



    $          (0.68)



    $          (0.65)



    $          (2.50)



    $          (2.50)

    Shares used in computing basic and diluted net loss per share



    91,081



    89,112



    90,774



    81,779

     

    Heron Therapeutics, Inc.

    Consolidated Balance Sheets

    (in thousands)







    December 31,

    2020



    December 31,

    2019







    ASSETS









    Current assets:









    Cash and cash equivalents



    $               105,138



    $               71,898

    Short-term investments



    103,353



    319,074

    Accounts receivable, net



    41,850



    39,879

    Inventory



    41,905



    24,968

    Prepaid expenses and other current assets



    21,950



    23,245

    Total current assets



    314,196



    479,064

    Property and equipment, net



    22,737



    19,618

    Right-of-use lease assets



    16,277



    13,754

    Other assets



    346



    346

    Total assets



    $             353,556



    $            512,782

    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $                    525



    $                2,758

    Accrued clinical and manufacturing liabilities



    49,962



    34,614

    Accrued payroll and employee liabilities



    13,597



    15,248

    Other accrued liabilities



    28,369



    36,535

    Current lease liabilities



    2,997



    1,926

    Convertible notes payable to related parties



    7,053



    5,624

    Total current liabilities



    102,503



    96,705

    Non-current lease liabilities



    14,561



    12,242

    Total liabilities



    117,064



    108,947











    Stockholders' equity:









            Preferred stock





            Common stock



    913



    903

    Additional paid-in capital



    1,628,070



    1,568,317

    Accumulated other comprehensive income



    257



    85

    Accumulated deficit



    (1,392,748)



    (1,165,470)

    Total stockholders' equity



    236,492



    403,835

    Total liabilities and stockholders' equity



    $             353,556



    $            512,782

     

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-and-twelve-months-ended-december-31-2020-and-highlights-recent-corporate-updates-301234154.html

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  4. SAN DIEGO, Feb. 17, 2021 /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 that Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • SVB Leerink 10th Annual Global Healthcare Conference: Wednesday, February 24, 2021 at 5:00 pm ET
    • Cowen 41st Annual Healthcare Conference: Monday, March 1, 2021 at 11:40 am ET

    A live webcast of each presentation will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of each…

    SAN DIEGO, Feb. 17, 2021 /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 that Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • SVB Leerink 10th Annual Global Healthcare Conference: Wednesday, February 24, 2021 at 5:00 pm ET
    • Cowen 41st Annual Healthcare Conference: Monday, March 1, 2021 at 11:40 am ET

    A live webcast of each presentation will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of each presentation will be archived on the site for 60 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. These risks and uncertainties include, but are not limited to, risks and uncertainties identified in the Company's filings with the 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.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-several-upcoming-virtual-investor-conferences-301230369.html

    SOURCE Heron Therapeutics, Inc.

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  5. SAN DIEGO, Jan. 21, 2021 /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 that the results from an EPOCH 1 follow-on study (NCT03718039) of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association in an article entitled "Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia." In this study, 77% of patients receiving HTX-011, along with postoperative…

    SAN DIEGO, Jan. 21, 2021 /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 that the results from an EPOCH 1 follow-on study (NCT03718039) of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association in an article entitled "Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia." In this study, 77% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) oral acetaminophen and ibuprofen, remained opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery. The mean pain intensity never rose above the mild range through 72 hours postoperatively.

    HTX-011 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 (EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair) 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 well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

    "A bunionectomy is a very painful surgical procedure that often requires opioids, which can come with adverse side effects, including nausea, vomiting, constipation and slowed breathing in addition to being potentially addictive," said Richard Pollak, M.D., DPM, a podiatric surgery specialist at San Antonio Podiatry Associates and an author of the publication. "Our findings from this study suggest that HTX-011 can serve as the foundation of a non-opioid multimodal analgesic (MMA) regimen, providing profound pain reduction and enabling opioid-free recovery for most bunionectomy patients through the 28-day recovery period."

    The Journal of the American Podiatric Medical Association article can be found here.

    About the EPOCH 1 Follow-On Study

    The EPOCH 1 follow-on study was an open-label, multi-cohort study evaluating the efficacy and safety of locally administered HTX-011 60 mg bupivacaine / 1.8 mg meloxicam via needle-free application into the surgical site in combination with a postoperative non-opioid MMA regimen of OTC oral acetaminophen and ibuprofen in 31 patients undergoing unilateral bunionectomy with osteotomy. Key results of the study include the following:

    • 77% of bunionectomy patients receiving HTX-011 with a scheduled non-opioid MMA regimen of OTC acetaminophen and ibuprofen required no opioids during recovery through 28 days (opioid-free).
    • 71% of bunionectomy patients receiving HTX-011 with a scheduled regimen of over-the-counter acetaminophen and ibuprofen did not experience severe pain.
    • The mean total opioid consumption over the 72-hour postoperative period was 1.61 morphine milligram equivalents.

    HTX-011 was well tolerated and demonstrated no safety concerns when used with postoperative non-opioid MMAs (OTC acetaminophen and ibuprofen).

    About HTX-011 for Postoperative Pain (ZYNRELEF in the European Union and European Economic Area)

    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 U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to HTX-011 and the New Drug Application (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 (CMC) issues were identified. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (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 European Union, and the other countries in the European Economic Area, including the United Kingdom.

    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 FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S., if approved; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's New Drug Submission (NDS) review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; 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.

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating Officer



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-epoch-1-follow-on-study-of-htx-011-in-patients-undergoing-bunionectomy-surgery-301212178.html

    SOURCE Heron Therapeutics, Inc.

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