HRTX Heron Therapeutics Inc.

15.53
-0.51  -3%
Previous Close 16.04
Open 16.26
52 Week Low 9.6
52 Week High 26.81
Market Cap $1,407,672,652
Shares 90,642,154
Float 74,434,807
Enterprise Value $1,122,951,150
Volume 2,276,031
Av. Daily Volume 1,504,708
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
HTX-011
Post operative pain
CRL
CRL
CRL announced June 29, 2020.
HTX-034
Postoperative Pain
Phase 1/2
Phase 1/2
Phase 1b/2 trial initiation announced May 18, 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, June 29, 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 that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June 26, 2020 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

    The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues. There…

    SAN DIEGO, June 29, 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 that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June 26, 2020 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

    The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised. The Company will request a Type A meeting to obtain agreement with the Agency on our responses and resubmit the application as quickly as possible.

    "We are committed to resolving the non-clinical issues outlined in the CRL with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron.

    Conference Call and Webcast

    Heron will host a conference call and webcast today, June 29, 2020, at 9:00 a.m. ET (6:00 a.m. PT). 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 3252267 to join the conference call. The conference call will be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of today's teleconference and webcast will be available on Heron's website for 60 days following the call.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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 June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. 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. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

    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 U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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; 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 Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-receives-complete-response-letter-for-htx-011-for-the-management-of-postoperative-pain-301084822.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  2. SAN DIEGO, June 4, 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 that the results from Study 209, a Phase 2b study of the investigational agent HTX-011 in primary unilateral total knee arthroplasty (TKA), have been published online by The Journal of Arthroplasty in an article entitled "HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial." All primary and key secondary endpoints in Study 209 were achieved, with HTX-011 demonstrating statistically significant reductions in…

    SAN DIEGO, June 4, 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 that the results from Study 209, a Phase 2b study of the investigational agent HTX-011 in primary unilateral total knee arthroplasty (TKA), have been published online by The Journal of Arthroplasty in an article entitled "HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial." All primary and key secondary endpoints in Study 209 were achieved, with HTX-011 demonstrating statistically significant reductions in pain intensity following surgery.

    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 significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard–of–care local anesthetic for postoperative pain control.

    In Study 209, patients undergoing primary unilateral TKA who received a single, needle-free application of HTX-011 demonstrated superior pain reduction when compared to patients receiving placebo or bupivacaine solution through 48 and 72 hours. In addition, patients receiving HTX–011 consumed fewer opioids when compared to patients receiving placebo or bupivacaine solution. Fewer patients receiving HTX-011 had severe pain through 72 hours, and more patients receiving HTX-011 were deemed ready for discharge at 8, 12 and 24 hours, both as compared to patients receiving placebo or bupivacaine solution. HTX-011 was well tolerated in Study 209, with a safety profile comparable to placebo and bupivacaine solution. 

    "Effective pain management is crucial after TKA to permit earlier mobilization, maximize patient satisfaction and facilitate outpatient surgery," said Alan J. Rechter, M.D., an orthopedic surgeon at Orthopaedic Associates, LLP. "Based on my experience in Study 209, the fast and easy needle-free administration of HTX-011 provided patients with effective and improved pain control despite taking fewer opioids."

    The Journal of Arthroplasty article can be found here.

    About Study 209

    Study 209 was a randomized, placebo- and active-controlled, double-blind, Phase 2b clinical study in patients undergoing primary unilateral total knee arthroplasty to evaluate the analgesic efficacy, safety and pharmacokinetics of HTX-011 locally administered into the surgical site. Following a dose-escalation phase, 232 patients were randomized, and 222 patients received treatment with: (1) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via instillation into the surgical site; (2) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via instillation into the surgical site plus a low dose of ropivacaine solution injected into the posterior capsule; (3) bupivacaine solution 125 mg administered via multiple injections into the surgical site; or (4) placebo. Ropivacaine solution and bupivacaine solution are generically available standard-of-care local anesthetics used in the management of postoperative pain. This study included a pre-specified hierarchical testing strategy for the primary and key secondary endpoints for the HTX-011 400 mg bupivacaine/12 mg meloxicam treatment groups. The primary endpoint was pain intensity as measured by the Area Under the Curve (AUC) from 0 to 48 hours post-surgery (AUC 0-48) for HTX-011 compared to placebo. The primary and key secondary endpoints were achieved:

    • HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 19% and 22%, respectively, in pain intensity through 48 hours when compared to placebo (p=0.0002 and p<0.0001, respectively).  
    • HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 18% and 22%, respectively, in pain intensity through 72 hours when compared to placebo (p=0.0004 and p<0.0001, respectively).
    • Sensitivity analyses using patient-reported pain scores without adjustment for opioid use confirmed that HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 29% and 27%, respectively, in pain intensity through 48 hours, and 28% and 26%, respectively, in pain intensity through 72 hours when compared to placebo (p≤0.0002 for both comparisons).
    • Sensitivity analyses using patient-reported pain scores without adjustment for opioid use confirmed that HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 19% and 17%, respectively, in pain intensity through 48 hours, and 17% and 16%, respectively, in pain intensity through 72 hours when compared to bupivacaine solution (P<0.05 for both comparisons).
    • Total opioid consumption for HTX-011 alone or in combination with ropivacaine solution was lower over 24, 48 and 72 hours when compared to placebo or bupivacaine solution.

    HTX-011 was well tolerated in Study 209, with a safety profile comparable to placebo and bupivacaine solution.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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. The Prescription Drug User Fee Act (PDUFA) goal date is June 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. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

    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 U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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; 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
    Chief Legal, Business and Administrative Officer
     
    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-study-209-a-phase-2b-study-of-htx-011-in-patients-undergoing-total-knee-arthroplasty-301070514.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  3. SAN DIEGO, May 18, 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 that it has initiated a Phase 1b/2 clinical study in patients undergoing bunionectomy of HTX-034, Heron's next-generation product for the treatment of postoperative pain. The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for HTX-034 for the treatment of postoperative pain.

    HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the…

    SAN DIEGO, May 18, 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 that it has initiated a Phase 1b/2 clinical study in patients undergoing bunionectomy of HTX-034, Heron's next-generation product for the treatment of postoperative pain. The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for HTX-034 for the treatment of postoperative pain.

    HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. HTX-034 is designed to provide superior and prolonged analgesia and enhance the activity of the local anesthetic bupivacaine via two different mechanisms. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

    The HTX-034 study is a randomized, active-controlled, double-blinded, Phase 1b/2 study in patients undergoing bunionectomy with an osteotomy and internal fixation. The study will evaluate the safety and efficacy of HTX-034 compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The Phase 1b portion of the study is intended to select the optimal dose for the Phase 2 expansion portion.

    "We are excited to progress HTX-034 into a proof-of-concept study in patients undergoing bunionectomy, a highly painful surgery, where we have the opportunity to evaluate the magnitude and duration of analgesia," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "In the same highly predictive animal model where we optimized HTX-011, HTX-034 has shown enhanced analgesic benefit for 7 days after surgery."

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid, is a fixed-dose combination, extended‑release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and 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-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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. The Prescription Drug User Fee Act (PDUFA) goal date is June 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. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

    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 U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 development program; 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
    Chief Legal, Business and Administrative Officer

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-initiation-of-phase-1b2-clinical-study-of-htx-034-for-the-treatment-of-postoperative-pain-301060550.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  4. SAN DIEGO, May 6, 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 months ended March 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.

    • Contract Manufacturing

    SAN DIEGO, May 6, 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 months ended March 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.

    • Contract Manufacturing Site for HTX-011: In February 2020, Heron announced that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns.

    • Marketing Authorisation Application for HTX-011 in the European Union: In March 2019, Heron's Marketing Authorisation Application (MAA) for HTX-011 for the management of postoperative pain was validated by the European Medicines Agency (EMA) for review under the Centralised Procedure. The medical device certification required for approval in the European Union (EU) for the custom Luer lock applicator developed for application of HTX-011 without a needle was delayed. An opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) is now anticipated in the second half of 2020.

    • New Drug Submission for HTX-011 in Canada: In December 2019, Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Health Canada's Priority Review status provides an accelerated 6-month review target for the NDS. Heron received the Certificate of Registration for the custom Luer lock applicator issued under the Medical Devices Single Audit Program for the medical device license in Canada. A decision by Health Canada on the NDS is anticipated in the third quarter of 2020.

    CINV Franchise

    • CINV Net Product Sales: For the three months ended March 31, 2020, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $25.4 million, compared to $31.6 million for the same period in 2019.

      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2020 were $25.2 million, compared to $28.0 million for the same period 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 months ended March 31, 2020 were $0.2 million, compared to $3.6 million for the same period 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: Heron expects 2020 net product sales for the CINV franchise of $70 million to $80 million and the CINV franchise to return to growth in 2021 and beyond.

    "We are encouraged by a recent communication with the FDA where they indicated that they continue on schedule with their review of the NDA for HTX-011, with a PDUFA date of June 26, 2020," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "For the CINV franchise, our customers are benefiting from the administration of CINVANTI by 2-minute IV push, an important product advantage compared to competitive products, which has led to strong first-quarter net product sales of $25.4 million."

    Financial Results

    Net product sales for the three months ended March 31, 2020 were $25.4 million, compared to $31.6 million for the same period in 2019.

    Heron's net loss for the three months ended March 31, 2020 was $51.6 million, or $0.57 per share, compared to $63.0 million, or $0.80 per share, for the same period in 2019. Net loss for the three months ended March 31, 2020 included non-cash, stock-based compensation expense of $12.0 million, compared to $17.9 million for the same period in 2019.

    As of March 31, 2020, Heron had cash, cash equivalents and short-term investments of $356.3 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the three months ended March 31, 2020 was $32.9 million, compared to $49.0 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

    HTX-011, an investigational non-opioid, 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. The Prescription Drug User Fee Act (PDUFA) goal date is June 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. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

    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.

    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: whether the U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 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; 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 Balance Sheets

    (In thousands)




    March 31,

    2020



    December 31,

    2019




    (Unaudited)





    ASSETS









    Current assets:









    Cash and cash equivalents


    $

    103,285



    $

    71,898


    Short-term investments



    253,061




    319,074


    Accounts receivable, net



    34,811




    39,879


    Inventory



    34,849




    24,968


    Prepaid expenses and other current assets



    12,442




    23,245


    Total current assets



    438,448




    479,064


    Property and equipment, net



    21,908




    19,618


    Right-of-use lease assets



    18,239




    13,754


    Other assets



    346




    346


    Total assets


    $

    478,941



    $

    512,782


    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable


    $

    11,562



    $

    2,758


    Accrued clinical and manufacturing liabilities



    35,321




    34,614


    Accrued payroll and employee liabilities



    8,770




    15,248


    Other accrued liabilities



    32,423




    36,535


    Current lease liabilities



    2,755




    1,926


    Convertible notes payable to related parties, net of discount



    5,934




    5,624


    Total current liabilities



    96,765




    96,705


    Non-current lease liabilities



    16,708




    12,242


    Total liabilities



    113,473




    108,947


    Stockholders' equity:









    Common stock



    906




    903


    Additional paid-in capital



    1,580,903




    1,568,317


    Accumulated other comprehensive income



    708




    85


    Accumulated deficit



    (1,217,049)




    (1,165,470)


    Total stockholders' equity



    365,468




    403,835


    Total liabilities and stockholders' equity


    $

    478,941



    $

    512,782












     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)



    Three Months Ended

    March 31,



    2020


    2019



    (Unaudited)


    Revenues:





        Net product sales

    $      25,400


    $         31,602


    Operating expenses:





        Cost of product sales

    10,622


    14,962


        Research and development

    36,894


    42,972


        General and administrative

    10,422


    9,648


        Sales and marketing

    20,196


    28,720


              Total operating expenses

    78,134


    96,302







    Loss from operations

    (52,734)


    (64,700)







    Other income, net

    1,155


    1,688







    Net loss

    $   (51,579)


    $      (63,012)







    Basic and diluted net loss per share

    $       (0.57)


    $         (0.80)







    Shares used in computing basic and diluted net loss per share

    90,409


    78,419


     

    HERON THERAPEUTICS, INC.

    Consolidated Statements of Cash Flows

    (In thousands)






    Three Months Ended

    March 31,






    2020



    2019






    (Unaudited)


    Operating activities:











    Net loss




    $

    (51,579)



    $

    (63,012)


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











    Stock-based compensation expense





    11,974




    17,902


    Depreciation and amortization





    621




    467


    Amortization of debt discount





    310




    247


    Realized gain on available-for-sale securities








    (8)


    Accretion of discount on short-term investments





    (117)




    (1,357)


    Impairment of property and equipment





    27




    27


    Loss on disposal of property and equipment








    52


    Change in operating assets and liabilities:











    Accounts receivable





    5,068




    (9,355)


    Prepaid expenses and other assets





    10,803




    (346)


    Inventory





    (9,881)




    7,611


    Accounts payable





    8,804




    (6,052)


    Accrued clinical and manufacturing liabilities





    707




    (868)


    Accrued payroll and employee liabilities





    (6,478)




    (6,757)


    Other accrued liabilities





    (3,194)




    12,425


    Net cash used for operating activities





    (32,935)




    (49,024)


    Investing activities:











    Purchases of short-term investments





    (28,922)




    (127,763)


    Maturities and sales of short-term investments





    95,675




    164,009


    Purchases of property and equipment





    (2,938)




    (2,136)


    Net cash provided by investing activities





    63,815




    34,110


    Financing activities:











    Proceeds from stock option exercises





    504




    6,539


    Proceeds from warrant exercises





    3





    Net cash provided by financing activities





    507




    6,539


    Net increase (decrease) in cash and cash equivalents





    31,387




    (8,375)


    Cash and cash equivalents at beginning of year





    71,898




    31,836


    Cash and cash equivalents at end of period




    $

    103,285



    $

    23,461


    Investor Relations and Media Contact:
    David Szekeres
    Chief Legal, Business and Administrative 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-31-2020-and-highlights-recent-corporate-updates-301053524.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  5. SAN DIEGO, March 2, 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 twelve months ended December 31, 2019 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. In February 2020, Heron announced that the FDA has extended the review period…

    SAN DIEGO, March 2, 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 twelve months ended December 31, 2019 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. In February 2020, Heron announced that the FDA has extended the review period for the NDA for HTX-011 by up to three months. The new Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.
    • Contract Manufacturing Site for HTX-011: In February 2020, Heron announced that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns.
    • Marketing Authorisation Application for HTX-011 in the European Union: In March 2019, Heron's Marketing Authorisation Application (MAA) for HTX-011 for the management of postoperative pain was validated by the European Medicines Agency (EMA) for review under the Centralised Procedure. An opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) is anticipated in the second quarter of 2020.
    • New Drug Submission for HTX-011 in Canada: In December 2019, Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Health Canada's Priority Review status provides an accelerated 6-month review target for the NDS. A decision by Health Canada is anticipated in the third quarter of 2020.

    CINV Franchise

    • CINV 2019 Net Product Sales: For the three months ended December 31, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $35.1 million, up 22% from the same period in 2018. For the twelve months ended December 31, 2019, CINV franchise net product sales were $146.0 million, up 88% from the same period in 2018.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2019 were $34.6 million and $132.2 million, respectively, compared to $23.4 million and $56.2 million, respectively, for the same periods in 2018.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2019 were $0.5 million and $13.8 million, respectively, compared to $5.4 million and $21.3 million for the same periods in 2018. On October 1, 2019, the Company made a business decision to discontinue all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales.
    • 2020 Net Product Sales Guidance: Heron expects 2020 net product sales for the CINV franchise of $70 million to $80 million and the CINV franchise to return to growth in 2021 and beyond.

    "We have made important advances in 2019 in both our pain management and CINV franchises, highlighted by the advancement of HTX-011 toward marketing approvals and strong sales for our CINV franchise," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. "We look forward to launching HTX-011 for postoperative pain management in the second half of 2020, pending FDA approval."

    Financial Results

    Net product sales for the three and twelve months ended December 31, 2019 were $35.1 million and $146.0 million, respectively, compared to $28.8 million and $77.5 million, respectively, for the same periods in 2018.

    Heron's net loss for the three and twelve months ended December 31, 2019 was $57.9 million and $204.7 million, or $0.65 per share and $2.50 per share, respectively, compared to $49.6 million and $178.8 million, or $0.63 per share and $2.44 per share, respectively, for the same periods in 2018. Net loss for the three and twelve months ended December 31, 2019 included non-cash, stock-based compensation expense of $11.1 million and $51.4 million, respectively, compared to $9.8 million and $33.4 million, respectively, for the same periods in 2018.

    As of December 31, 2019, Heron had cash, cash equivalents and short-term investments of $391.0 million compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the twelve months ended December 31, 2019 was $124.6 million, compared to $191.8 million for the same period in 2018. 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

    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. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020. A Marketing Authorisation Application (MMA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

    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.

    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: whether the U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 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.

    Consolidated Balance Sheets

    (In thousands, except par value amounts)




    December 31,

    2019



    December 31,

    2018






    ASSETS









    Current assets:









    Cash and cash equivalents


    $

    71,898



    $

    31,836


    Short-term investments



    319,074




    300,535


    Accounts receivable, net



    39,879




    64,652


    Inventory



    24,968




    39,032


    Prepaid expenses and other current assets



    23,245




    11,193


    Total current assets



    479,064




    447,248


    Property and equipment, net



    19,618




    14,677


    Right-of-use lease assets



    13,754





    Other assets



    346




    254


    Total assets


    $

    512,782



    $

    462,179


    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable


    $

    2,758



    $

    16,863


    Accrued clinical and manufacturing liabilities



    34,614




    24,470


    Accrued payroll and employee liabilities



    15,248




    13,397


    Other accrued liabilities



    36,535




    32,715


    Current lease liabilities



    1,926





    Convertible notes payable to related parties, net of discount



    5,624




    4,574


    Total current liabilities



    96,705




    92,019


    Non-current lease liabilities



    12,242





    Total liabilities



    108,947




    92,019


    Commitments and contingencies









    Stockholders' equity:









    Preferred stock, $0.01 par value: 2,500 shares authorized; no shares issued or outstanding at December 31, 2019 and 2018







    Common stock, $0.01 par value: 150,000 shares authorized; 90,304 and 78,174 shares issued and outstanding at December 31, 2019 and 2018, respectively



    903




    782


    Additional paid-in capital



    1,568,317




    1,330,186


    Accumulated other comprehensive income (loss)



    85




    (87)


    Accumulated deficit



    (1,165,470)




    (960,721)


    Total stockholders' equity



    403,835




    370,160


    Total liabilities and stockholders' equity


    $

    512,782



    $

    462,179


     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)



    Three Months Ended

    December 31,


              Twelve Months Ended

    December 31,


    2019


    2018


    2019


    2018


    (unaudited)





    Revenues:








        Net product sales

    $    35,083


    $      28,844


    $  145,968


    $   77,474

    Operating expenses:








        Cost of product sales

    15,874


    11,572


    61,619


    27,512

        Research and development

    48,277


    39,891


    167,382


    140,032

        General and administrative

    9,874


    8,738


    37,897


    29,263

        Sales and marketing

    20,420


    19,957


    89,764


    64,604

              Total operating expenses

    94,445


    80,158


    356,662


    261,411









    Loss from operations

    (59,362)


    (51,314)


    (210,694)


    (183,937)









    Other income, net

    1,442


    1,755


    5,945


    5,097









    Net loss

    $   (57,920)


    $      (49,559)


    $  (204,749)


    $  (178,840)









    Basic and diluted net loss per share

    $       (0.65)


    $          (0.63)


    $        (2.50)


    $        (2.44)









    Shares used in computing basic and diluted net loss per share

    89,112


    78,086


    81,779


    73,193

     

    HERON THERAPEUTICS, INC.

    Consolidated Statements of Cash Flows

    (In thousands)




    Years Ended December 31,




    2019



    2018



    2017






    Operating activities:













    Net loss


    $

    (204,749)



    $

    (178,840)



    $

    (197,484)


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













    Stock-based compensation expense



    51,411




    33,367




    30,538


    Depreciation and amortization



    2,044




    1,513




    1,531


    Amortization of debt discount



    1,050




    890




    773


    Accretion of discount on short-term investments



    (3,730)




    (3,412)




    (278)


    Realized gain on available-for-sale investments



    (8)








    Impairment of property and equipment



    107




    72





    Loss on disposal of property and equipment



    62




    29




    39


    Change in operating assets and liabilities:













    Accounts receivable



    24,773




    (22,778)




    (39,914)


    Prepaid expenses and other assets



    (12,052)




    (7,482)




    3


    Inventory



    14,064




    (29,122)




    (4,768)


    Accounts payable



    (14,105)




    (1,906)




    11,955


    Accrued clinical and manufacturing liabilities



    10,144




    (3,614)




    13,713


    Accrued payroll and employee liabilities



    1,851




    4,537




    446


    Deferred revenue









    1,664


    Other accrued liabilities



    4,558




    14,941




    11,482


    Net cash used for operating activities



    (124,580)




    (191,805)




    (170,300)


    Investing activities:













    Purchases of short-term investments



    (477,035)




    (497,104)




    (121,570)


    Maturities and sales of short-term investments



    462,406




    227,700




    131,783


    Purchases of property and equipment



    (7,154)




    (9,171)




    (2,553)


    Proceeds from the sale of property and equipment






    25




    78


    Net cash (used for) provided by investing activities



    (21,783)




    (278,550)




    7,738


    Financing activities:













    Net proceeds from sale of common stock and/or pre-funded warrants



    162,151




    363,128




    306,279


    Proceeds from purchases under the Employee Stock Purchase Plan



    2,109




    1,179




    989


    Proceeds from stock option exercises



    22,164




    18,301




    11,463


    Proceeds from warrant exercises



    1








    Repayment of promissory note payable to related party






    (25,000)




    (25,000)


    Net cash provided by financing activities



    186,425




    357,608




    293,731


    Net increase (decrease) in cash and cash equivalents



    40,062




    (112,747)




    131,169


    Cash and cash equivalents at beginning of year



    31,836




    144,583




    13,414


    Cash and cash equivalents at end of year


    $

    71,898



    $

    31,836



    $

    144,583


    Supplemental disclosure of cash flow information:













    Interest paid


    $



    $

    1,183



    $

    2,789


    Cumulative effect of adoption of new accounting standard


    $



    $

    1,574



    $


    Investor Relations and Media Contact:
    David Szekeres
    Chief Legal, Business and Administrative 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-31-2019-and-highlights-recent-corporate-updates-301013982.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
View All Heron Therapeutics Inc. News