false HERON THERAPEUTICS, INC. /DE/ 0000818033 0000818033 2020-01-13 2020-01-13

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 13, 2020

 

Heron Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-33221		94-2875566
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

4242 Campus Point Court, Suite 200, San Diego, CA		92121
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code (858) 251-4400

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.01 per share		HRTX		The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On January 13, 2020, Heron Therapeutics, Inc. (the “Company”) issued a press release announcing, among other things, certain of its financial results for the three and twelve months ended December 31, 2019 (the “Press Release”). A copy of the Press Release is furnished herewith as Exhibit 99.1.

This Item 2.02 and the Press Release attached hereto as Exhibit 99.1 are being furnished to the Securities and Exchange Commission.

 

Item 7.01 Regulation FD Disclosure.

Press Release.

On January 13, 2020, the Company issued the Press Release providing, among other things, a general update on corporate progress, as described in the Press Release.

Corporate Presentation.

A copy of presentation materials describing the business of the Company, all or a part of which may be used by the Company in investor or scientific presentations from time to time, is furnished herewith as Exhibit 99.2 (the “Corporate Presentation”). The Corporate Presentation has also been posted on the Company’s website at www.herontx.com. The Company does not undertake any obligation to update the Corporate Presentation.

This Item 7.01, the Press Release and the Corporate Presentation are being furnished to the Securities and Exchange Commission.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated January 13, 2020
99.2		Corporate Presentation, dated January 13, 2020
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

			Heron Therapeutics, Inc.
Date: January 13, 2020			/s/ David Szekeres
			David Szekeres Chief Legal, Business, and Administrative Officer

 

Exhibit 99.1

 

 

Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises

 

- Marketing Applications for HTX-011 for Postoperative Pain Management Are under Review in the United States, the European Union and Canada -

 

- Preliminary Fourth-Quarter 2019 Net Product Sales for CINV Franchise of Approximately $34.8 Million, up 21% Year-over-Year -

 

- Preliminary Full-Year 2019 Net Product Sales for CINV Franchise of Approximately $145.7 Million, versus Guidance of $135.0 Million -

 

- December 31, 2019 Cash, Cash Equivalents and Short-Term Investments of Approximately $391.0 Million -

- Attending the 38^th Annual J.P. Morgan Healthcare Conference -

 

SAN DIEGO, Calif.–(PR NEWSWIRE)–January 13, 2020 -- 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 highlighted progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises.

 

Recent Corporate Progress

 

Pain Management Franchise

 

 

 

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CINV Franchise

 

 

Corporate Update

 

 

“We have made important advances in 2019 in both our pain management and CINV franchises, highlighted by the submission of three marketing applications for HTX-011 for postoperative pain management and strong net product sales for CINVANTI, even amid the launch of generic fosaprepitant,” said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. “We ended 2019 in a strong cash position of $391.0 million, which will support the anticipated launch of HTX-011 in the second quarter of 2020, pending FDA approval.”

 

About HTX-011 for Postoperative Pain

 

HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019 and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. Heron's

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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 HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

 

Please see full prescribing information at www.CINVANTI.com.

 

About SUSTOL (Granisetron) Extended-Release Injection

 

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT₃ receptor antagonist that utilizes Heron’s Biochronomer^® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

 

Please see full prescribing information at www.SUSTOL.com.

 

About Heron Therapeutics, Inc.

 

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer.

 

For more information, visit www.herontx.com.

 

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Forward-Looking Statements

 

This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: the fourth-quarter 2019 and full-year 2019 net product sales for the CINV franchise; 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 (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission authorizes the Marketing Authorization 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 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.

 

Investor Relations and Media Contact:

 

David Szekeres
Chief Legal, Business, and Administrative Officer
dszekeres@herontx.com

858-251-4447  

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Heron Therapeutics JPM Update January 13, 2020 Exhibit 99.2

Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this presentation, and involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, those associated with: the fourth-quarter 2019 and full-year 2019 net product sales for the CINV franchise; whether the FDA approves the NDA for HTX-011; the timing of the FDA’s review process for HTX-011; the timing of the commercial launch of HTX-011; the timing of the CHMP’s review process for HTX-011; whether the European Commission authorizes the MAA for HTX-011; the 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 potential market opportunity for CINVANTI, SUSTOL and HTX-011; the timing and results of the studies in the HTX-011 and HTX-034 development programs; 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 Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and we take no obligation to update or revise these statements except as may be required by law.

Heron Pipeline We are currently developing and commercializing pharmaceutical products for patients suffering from cancer or postoperative pain: SUSTOL® (granisetron) extended-release injection Fast Track and Breakthrough Therapy designations granted NDA received Priority Review; CRL received 30 Apr 2019 The CRL identified issues relating to CMC and non-clinical No issues related to clinical efficacy or safety were noted. Revised NDA submitted 26 Sep 2019 addressing CRL New PDUFA date: 26 March 2020 EU MAA filing by Centralised Procedure in March 2019 Potential CHMP opinion 2Q2020 Canadian NDS screening completed Potential approval in early 3Q2020 CINV* US FDA Approved for CINV Prevention* Under Investigation for Postoperative Pain via Local Application CINVANTI® (aprepitant) injectable emulsion US FDA Approved for CINV Prevention* HTX-011 PAIN MANAGEMENT CLINICAL NDA APPROVED PRECLINICAL CLINICAL NDA APPROVED PRECLINICAL *CINV: Chemotherapy-induced nausea and vomiting. SUSTOL® (granisetron) extended-release injection 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. CINVANTI® (aprepitant) injectable emulsion, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI has not been studied for treatment of established nausea and vomiting. Produces complete elimination of pain for 7 days in validated pig model of postoperative pain Under Investigation for Postoperative Pain via Local Application HTX-034 HTX-011 and HTX-034 are an investigational new drugs and are not approved by the FDA or other regulatory authority 2-minute IV Push Approved 26 Feb 2019

$ As many as 6.5% of patients who take opioids to manage pain after surgery may become persistent opioid users.1 That equals about 2.9 MILLION PEOPLE.1 MORE THAN 50 MILLION surgical procedures happen in the United States.1 90% of patients undergoing a surgical procedure are prescribed opioids for pain management.2 Of these 2.6 million persistent opioid users, approximately ~500,000 will become addicted to opioids.3 In addition, opioid discharge prescriptions filled by recovering surgical patients result in more than 1 billion unused pills.4,5 70% of all these opioid tablets go unused.2 90% of these pills remain inside the home in unsecured locations.6 More than $13 billion of the annual healthcare costs associated with addiction can be attributed to postoperative pain management.1,3,8 32% of all opioid addicts report first opioid exposure through leftover pills.7 References: 1. Brummett, Chad M., et al. 2017. “New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults.” JAMA Surgery 152 (6): e170504. doi:10.1001/jamasurg.2017.0504. 2. Hill, Maureen V., et al. 2017. “Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures.” Annals of Surgery 265 (4): 709 -714. 3. Banta-Green, et al (2009). Opioid use behaviors, mental health and pain—Development of a typology of chronic pain patients. Drug and Alcohol Dependence 104(1-2), 34-42. _https://-doi.org/10.1016/j.drugalcdep.2009.03.021. 4. CDC 2017: Centers for Disease Control and Prevention. Opioid Overdose: U.S. Prescribing Rates Map. Available at https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html. Accessed 8 March 2018. 5. Levy et al. “Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012.” Am J Prev Med. 2015;49(3):409-413. 6. Bates, et al. 2011. “Overprescription of Postoperative Narcotics: A Look at Postoperative Pain Medication Delivery, Consumption and Disposal in Urological Practice.” The Journal of Urology 185 (2): 551 -55. doi:10.1016/j.juro. 2010.09.088. 7. Canfield, Marta C., et al. 2010. “Prescription Opioid Use Among Patients Seeking Treatment for Opioid Dependence:” Journal of Addiction Medicine 4 (2): 108 -13. doi:10.1097/ADM.0b013e3181b5a713. 8. The Council of Economic Advisers, 2017. The Underestimated Cost of the Opioid Crisis. The Cost of Opioids How Postoperative Opioids Can Be a Doorway to Addiction

Clinical Studies in High-Value Procedures Have Demonstrated Significantly Better Pain Reduction Than Bupivacaine Procedure Annual Volume (‘000s, US) % Local Anesthetic Use Significantly Reduced Pain vs BPV† Total Procedures Inpatient Outpatient (C-code) ASC (C-Code) Medicare Non-Medicare** Survey Ortho Surgery Knee arthroplasty 1,043 977 41 25 41% 59% 86% √ Hip arthroplasty 599 579 8 12 42% 58% 80% Shoulder arthroplasty 161 149 9 3 47% 53% 85% Rotator cuff repair 319 6 193 120 27% 73% 81% Spine procedures 1,459* 928 456 75 34% 66% 76% Bunionectomy 597 42 343 212 25% 75% 88% √ General Surgery Hernia repair 1,064 212 731 121 26% 74% 82% √ Cholecystectomy 987 323 600 64 10% 90% 83% Colon and sm bowel resection 476 457 18 1 33% 67% 75% Plastic Surgery Abdominoplasty 130 23 95 12 16% 84% 75% √ Mammoplasty 292 32 208 52 16% 84% 79% √ OB/GYN C-Section 1,168 1158 10 0 2% 98% 58% Completed studies On-going studies * Includes Laminectomy, Foraminotomy, Discectomy, Fusion ** Non Medicare includes Commercial, Medicaid and Cash Sources: DRG Claims Data 2017/ update 2018 The Link Group ATU survey May 2019 †HTX-011 produced significantly greater pain reduction than bupivacaine in Phase 2 and/or Phase 3 trials

The Commercialization of HTX-011 Advancing Pain Management HTX-011 is an investigational new drug and not approved by the FDA

EXISTING PLATFORM ADVANTAGES Established Platform With Experienced Teams in Place We are prepared for the launch of HTX-011. Our critical teams are already in place, with extensive experience in successful hospital launches. Strong KOL relationships Successful hospital and pain management launch experience IDN/hospital/ASC expertise and relationships Reimbursement infrastructure in place GPO contracts in place Full Line Wholesaler agreements and 3PL in place Safety monitoring structure in place Proven compliant execution Robust systems in place and pressure tested for blockbuster launch Commercial Leadership Key Account Management Payer GPO Trade and Distribution Pharmaco- vigilance Regulatory and Compliance Backbone Infrastructure Medical Science Liaisons

Heron has Successfully Launched a Hospital Product and Achieved >40% Market Share From Entrenched Competitor SOURCE: 867 1.8.20, IMS DDD 12.27.19 CINVANTI Hospital Share/Units Hospital share Hospital Units 528 7990 28751 51471 66774 87803 103124 118767 65% 60% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 55%

CINVANTI Achieved Significant Penetration in Both the 340B and Non-340B Hospital Market   SOURCE: 867 1.8.20, IMS DDD 12.27.19

CINVANTI HTX-011 Market Category NK1 - CINV Local Anesthetics Annual Units 800,000 NK1 units in hospital 14M* Brand Leader - Unit Share EMEND IV 100% EXPAREL 7% 1.0M** units Generics at Launch - Unit Share No 0% YES 93% New P&T Review Yes Yes Clinical Differentiation Yes – PS-80 free Yes – beat SOC Ease of Use High – IV push, infusion High - installation Price Strategy vs. Brand 20% discount Discount to brand likely 340b Pricing Offer Yes Yes Brand 340b Pricing Yes No 3-year pass-through Yes Yes Hospital Launch Analysis HTX-011 and CINVANTI Have Very Similar Profiles *Lexus Target Procedures Q3 17-Q3 18 ** SHA Pac units Q3 17 –Q3 18 HTX-011 is an investigational new drug and not approved by the FDA

The Market is Large and Waiting for an Effective Non-opioid Solution Potential Target Market Target Procedures (Initial Targets) Higher-volume procedures across 4 major specialties ~6.0MOrthopedic procedures ~4.5MGeneral surgery procedures ~2.6MOB/GYN procedures ~900KPlastic surgery procedures Secondary Targets Higher-volume procedures in non-core specialties (eg, ENT, urology, hand, others) Tertiary Targets Lower-volume procedures and procedures where local anesthetics are not widely used today ~30M Annual U.S. Surgical Procedures Requiring Postoperative Pain Management ~14M Initial Target Procedures ~7M Procedures ~9M Procedures Potential Market Size ~$2.8B ~$1.3B ~$1.7B Source: DRG Claims Analysis, 2016 and 2019

Local Anesthetics grew +22% in value and +26% in pack units in 2018, while opioids declined Large increase in ropivacaine driven by increased use of nerve block to decrease need for opioids Exparel volume growth was primarily driven by the 10ml vial and limited nerve block indication Branded Product Utilization Has Grown and is Approaching ~$1B Shift Away From Opioids Continues Product Pack Units % Change WAC % Change Avg. Cost per Patient Bupivacaine 20.8M 21% $44M 31% $5-7 Ropivacaine 1.6M 138% $24M 159% $39 Exparel 1.1M 20% $323M 16% $298 Ofirmev 10.8M 8% $422M 14% $86 On-Q* - - ~$150M - ~$320 Opioids 178.6M (18%) $1.1B (13%) - Symphony PHAST – 2017-2019 Market Data * Avanos Earnings Call 11/05/19 ; Amazon.com: Halyard Health P400X5 ON-Q Pump Fixed Flow, 400 mL, 5 mL/hour Flow Rate (Pack of Price: $1,592.58 (5 pump pack)

Clear Shift from Inpatient (no reimbursement) to Outpatient and ASC With Opportunity for Pass-Through HTX-011 has Strategic Advantages Across All Settings of Care 52% » 47% Hospital Inpatient (6.6M procedures) Part of DRG payment Multiple SKUs - lower average cost ~50% connected 340B hospitals 39% » 43% Hospital Outpatient (6M procedures) 3-year pass through (C-Code) 340B opportunity Multiple SKUs - lower average cost Hospitals account for 90% (down from 91%), with 5% decline in inpatient procedures 8% » 9% Ambulatory Surgical Centers (ASCs) (1.3M procedures) ASP +6% Lower access barriers Targeted facilities Connected to top IDNs Multiple SKUs - lower average cost Ambulatory surgical centers account for 9% The remaining 1% of procedures are performed at private physician practices 13.4 » 14 MILLION INITIAL TARGET PROCEDURES 52% of the opportunity lends itself to favorable pricing, access and reimbursement Source: 2015/2018 DRG Claims Data: Procedures validated with thorough medical review for applicable procedures, DRG Claims and Lexis Nexis for annual volume – SHA for Drug Sales

Improved Pain Management and Reduced Opioid Use with HTX-011 Can Potentially Move More Procedures to the Outpatient Setting Source: Table 14.2.13.2 *MPADSS, modified postanaesthetic discharge scoring system. The proportion of subjects who first achieve an MPADSS score ≥9 at each timepoint was analyzed cumulatively. P-values from Fisher's exact test. p-value vs PBO:0.0070.0030.0220.0010.0770.010 P-value vs BPV:0.3470.1850.3480.0550.2430.068 HTX-011 is an investigational new drug and not approved by the FDA Significantly Faster Time to “Discharge Ready” with HTX-011 in TKA

340B + Branded Postop Pain Medication Use Inpatient Outpatient # of Hospitals Formulary Timing # Target Procedures Branded Pain Meds # Procedures Branded Pain Meds 62 0-3 200K $23M 184K $15M 201 4-8 676K $65M 624K $43M Initial Launch Focus – Fast Moving 340b Hospitals Currently Using Branded Postop Pain Medication Non-340B + Branded Postop Pain Medication Use Inpatient Outpatient # of Hospitals Formulary Timing # Target Procedures Branded Pain Meds # Procedures Branded Pain Meds 55 0-3 380K $30M 182K $20M 188 4-8 530K $59M 489K $39M ($38M) ($108M) ($50M) ($98M)

HTX-011 is Focused on the Largest Market Opportunity – Local Application THE LARGEST OPPORTUNITY TO DRIVE VALUE AND CREATE CHANGE NB: Nerve Block N = 22M Procedures DRG Foundational Insights Research Dec. 2016 Bupivacaine lidocaine Exparel others Ropivacaine NB Bupivacaine NB

HTX-011 Demonstrated Significant Pain Reduction in Nerve Block HTX-011 Instillation has Also Demonstrated Superiority to Bupivacaine NB and Similar Pain Reduction to HTX-011 Nerve Block Study 211: Compared to Placebo, Pain Reduction with HTX-011 Instillation Approximately Triple that of Bupivacaine Nerve Block Reference: Table 14.2.4.1 Program: J:\htx011\211\csr\prog\posthoc_f_14.2.10_auc_r_24h_htx400_wwocf_pctchg.sas.sas 14NOV2019 2.8x Greater Pain Reduction Than BPV Nerve Block vs PBO 2.9x Greater Pain Reduction Than BPV Nerve Block vs PBO Nerve Block Nerve Block Instillation Study 211: Phase 2b Breast Augmentation Mammoplasty HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 Demonstrated Significant Reduction in Opioid Use with both Nerve Block and Instillation Opioid consumption is presented in mean milligrams of morphine equivalents 3.2x Greater Opioid Reduction Than BPV Nerve Block vs PBO 2.6x Greater Opioid Reduction Than BPV Nerve Block vs PBO Study 211: Compared to Placebo, HTX-011 Instillation has Demonstrated Significantly Greater Opioid Reduction Compared to Bupivacaine NB Nerve Block Nerve Block Instillation Study 211: Phase 2b Breast Augmentation Mammoplasty HTX-011 is an investigational new drug and not approved by the FDA

Cross-Study Comparison of TKA Study 306 to Published Adductor Canal Nerve Block Study HTX-011 + MMA Produced Comparable or Better Pain Scores Than Nerve Block Single-Shot Adductor Canal Block (SACB) & Continuous Adductor Canal Block (CACB) with MMA1 1. Canbek, et al. https://doi.org/10.1016/j.aott.2019.04.001 Patients received either a single administration or continuous infusion of bupivacine plus IV diclofenac or APAP as MAA HTX-011 + MMA with APAP and Celecoxib in Study 306 Nerve Block Conclusions HTX-011 nerve block significantly reduced pain Instillation of HTX-011 reduced pain just as well and appears to be as good or better than bupivacaine nerve block, even with continuous infusion HTX-011 is an investigational new drug and not approved by the FDA [Hour post study Drug Administration Graphics] [postoperative Hours]

Physicians indicated a raw preference share of 56% for HTX-011 across the covered procedures Overall Wt. Average Preference Share Preference Share (%, Raw) 56% Raw preference share for HTX-011 from physicians: 56% The top procedures where physicians expected to use HTX-011 were knee arthroplasty and hernia repair Several procedures saw higher raw preference shares than prior market research, notably knee & hip arthroplasty, C-section, laparoscopic hysterectomy and spine procedures >1M Procedures in 2035 >500K Procedures in 2035 <500K Procedures in 2035 Reference: DRG Postoperative Pain Quantitative Research (Nov 2018) - n = 290 physicians; *Less than 100K procedures at peak

Adjusted Physician Preference Share Distribution -44% -44% -45% Future Therapy (Applying HTX-011 preference share) Current Therapy (Actual) (e.g. lidocaine, ropivacaine, generic combo, etc.) HTX-011 Enjoyed a Physician Preference Share of 44% Current therapy based on Claims data from 2017 for Exparel, other agents are based on 2018 Physician Survey Data from analysis of physician static survey & conjoint - Sample includes n = 330 physicians HTX-011 is likely to initially convert share from Exparel, as well as the rest of the local anesthetics (bupivacaine & other “caines”) There is an additional opportunity to convert physicians not using local anesthetics; physicians indicated a willingness to use HTX-011 in ~30% of procedures where they are currently not using local anesthetics

Pharmacy Directors Surveyed Prefer HTX-011 to Exparel® Reference: DRG Pharmacy Director Survey (2018): Q27. What would happen to EXPAREL if Product X was approved on formulary at your institution? Impact of HTX-011 Launch on Exparel Formulary Status Most pharmacy directors indicate HTX-011 would displace Exparel on formulary Over 50% of pharmacy directors report that if HTX-011 became available on their institution’s formulary, Exparel would be subject to greater restrictions or would be entirely removed from formulary For institution’s with less formulary consolidation, Exparel may continue to be stocked to accommodate a small segment of patients not using HTX-011 N = 40 Pharmacy Directors “We can encourage use of [HTX-011] by making use of standing order sets and our EMR system, so if we continued to carry Exparel, we would make it restricted to only patients contraindicated to Product X.” – Pharmacy Director Formulary Status of Exparel vs. Expected HTX-011 Status

High Procedure Volume in Target Markets Provides a Robust ROW Market Opportunity Country Total Surgical Procedures Total Procedures Requiring Postop Pain Management Initial Target Procedures Remaining Secondary, Lower Volume & Procedures Currently Not Using Local Anesthetics Germany 18.6M 6.8M 4.0M 2.8M France 13.5M 4.4M 2.5M 1.9M UK 11.8M 3.8M 2.4M 1.4M Italy 10.1M 2.6M 1.9M 0.7M Spain 6.5M 2.1M 1.6M 0.5M Top 5 EU Total 60.5M 19.7M 12.4M 7.3M Canada 6.0M 1.6M 1.2M 0.4M Japan 26.0M 6.6M 2.7M 3.9M

Heron is Well Positioned to Execute a Blockbuster Launch for HTX-011 Proven track record with hospital launch success Existing robust platform and structure to support launch Significant unmet need and market opportunity Highly focused launch strategy to accelerate sales Unprecedented value proposition HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 Development Program Advancing Pain Management HTX-011 is an investigational new drug and not approved by the FDA

With a pKa of 8.1, bupivacaine is sensitive to reduced pH The acidic environment associated with inflammation results in far less drug penetrating the nerve membrane and reduced anesthetic effects1,2 Local Anesthetics Exist in a Balance Between Water- and Lipid-Soluble Forms Inflammation produces an acidic environment With a one pH unit drop, 10-fold less bupivacaine is able to penetrate the nerve cell membrane A Potential Hypothesis: Inflammation, pH, and Local Anesthetic Failure HTX-011 is an investigational new drug and not approved by the FDA

1 Postoperative pain model in pigs from Castle et al, 2013 EPJ 2 Human dose of liposomal bupivacaine with 40% smaller incision (n=4 pigs in each arm) Increasing Analgesia 2 HTX-011 is Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery as Demonstrated in this Preclinical Model1 HTX-011 is an investigational new drug and not approved by the FDA

p=0.0154 vs. HTX-002* p<0.0001 vs. HTX-009* p=0.0208 vs. HTX-002* p=0.0005 vs. HTX-009* p=0.0333 vs. HTX-002* p=0.0090 vs. HTX-009* *p-value from ANOVA, LSMD of area under the curve for HTX-011 vs. HTX-002 or HTX-009 p=0.2041 vs. HTX-002* p<0.0035 vs. HTX-009* p=0.0592 vs. HTX-002* p<0.0042 vs. HTX-009* p=0.0333 vs. HTX-002* p=0.0072 vs. HTX-009* HTX-011 Reduces Pain Better Than the Individual Components in Both Bunionectomy and Herniorrhaphy Phase 2 Studies HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 is a single-dose application administered via a needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing HTX-011 is Applied into the Surgical Site at the End of Surgery Without a Needle Reference: Data on file. HTX-011 is an investigational new drug and not approved by the FDA

Study Phase Surgical Model Tissue Type Significant for Pain Reduction vs. PBO Significant for Pain Reduction vs. BPV Significant Reduction in Opioid Use 202 2 Herniorrhaphy Soft ü ü ü 203 2 Abdominoplasty Soft ü ü ü 208 2 Bunionectomy Bony ü ü ü 209 2b TKA Bony ü ü ü 211 2b Breast Augmentation Soft ü ü ü 301 3 Bunionectomy Bony ü ü ü 302 3 Herniorrhaphy Soft ü ü ü PBO = placebo; BPV = bupivacaine solution; TKA = total knee arthroplasty Seven Active-Controlled Studies Showing Significantly Better Pain Reduction With HTX-011 Than Bupivacaine Included in NDA HTX-011 is an investigational new drug and not approved by the FDA

EPOCH 1: Bunionectomy Results (Study 301) EPOCH 1 Follow-on: Opioid Elimination Study in Bunionectomy

EPOCH 1 Bunionectomy: HTX-011 Provided Superior Pain Reduction Through 72-hours * Using Numeric Rating Scale (NRS) with window worst observation carried forward (wWOCF) Time (hour) Pain Intensity Score* (Mean ± SE) AUC0-24 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p < 0.0001 AUC24-72 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p = 0.0072 AUC0-72 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p = 0.0002 HTX-011 60 mg (N=157) Saline Placebo (N=100) Bupivacaine HCI 50 mg (N=155) Severe pain (≥ 7) HTX-011 is an investigational new drug and not approved by the FDA

EPOCH 1 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours HTX-011 60 mg (N=157) Saline Placebo (N=100) Bupivacaine HCI 50 mg (N=155) Severe pain ≥ 7 Mild pain (0-4) Time (hour) EPOCH 1 Follow-on: HTX-011 ≤ 60 mg + OTC (N=31) OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h * Using Numeric Rating Scale (NRS) with window worst observation carried forward (wWOCF) Pain Intensity Score* (Mean ± SE) HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 Significantly Reduced Total Opioid Consumption 1. Based on morphine milligram equivalents p = 0.0022 p < 0.0001 Opioid Consumption (Mean MME1 ± SE) 0-72 Hours N=31 EPOCH 1 Follow-on N=100 N=155 N=157 OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h EPOCH 1 (Bunionectomy) HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 Significantly Increased Proportion of Opioid-Free Patients p = 0.0001 p < 0.0001 % Opioid-free Through 72 Hours EPOCH 1 Follow-on N=31 EPOCH 1 (Bunionectomy) N=100 N=155 N=157 OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h 100% remained opioid free through Day 28 HTX-011 is an investigational new drug and not approved by the FDA

EPOCH 2: Herniorrhaphy Results (Study 302) EPOCH 2 Follow-on: Opioid Elimination Study in Herniorrhaphy

EPOCH 2 Herniorrhaphy: HTX-011 Provided Superior Pain Reduction Through 72-hours Time (hour) Mean Pain Intensity Score (SE) AUC0-24 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p < 0.0001 AUC24-72 HTX-011 vs P: p = 0.0264 HTX-011 vs B: p = 0.0007 AUC0-72 HTX-011 vs P: p = 0.0004 HTX-011 vs B: p < 0.0001 Severe pain (≥ 7) HTX-011 300 mg (N=164) Saline Placebo (N=82) Bupivacaine HCI 75 mg (N=172) Source: Figure 14.2.7 HTX-011 is an investigational new drug and not approved by the FDA

EPOCH 2 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours Time (hour) Mean Pain Intensity Score (SE) HTX-011 300 mg (N=164) Saline Placebo (N=82) Bupivacaine HCI 75 mg (N=172) Source: Figure 14.2.7 HTX-011 is an investigational new drug and not approved by the FDA Mild pain (0-4) EPOCH 2 Follow-on: HTX-011 300 mg + OTC (N=33) Severe pain (≥ 7) OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h

HTX-011 Significantly Reduced Total Opioid Consumption 1. Based on morphine milligram equivalents N=82 N=172 N=164 p = 0.0240 p < 0.0001 EPOCH 2 (Herniorrhaphy) N=33 EPOCH 2 Follow-on OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h Opioid Consumption (Mean MME1 ± SE) 0-72 Hours HTX-011 is an investigational new drug and not approved by the FDA

HTX-011 Significantly Increased Proportion of Opioid-Free Patients p = 0.0486 p < 0.0001 EPOCH 2 Follow-on EPOCH 2 (Herniorrhaphy) % Opioid-free Through 72 Hours N=82 N=172 N=164 N=33 40.1% OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h 93% remained opioid free through Day 28 90.9% HTX-011 is an investigational new drug and not approved by the FDA

HOPE-1: Real World Evidence of Opioid-Free Recovery Post Inguinal Herniorrhaphy with HTX-011 + OTC Analgesics

HOPE-1: Near Total Opioid-Free Recovery with HTX-011 + OTC 5% N=93 in initial pilot program 93% HTX-011 is an investigational new drug and not approved by the FDA

Potential Reduction of Discharge Opioids Based on HOPE-1 Currently, following inguinal hernia repair an average of 30 opioid pills are prescribed per patient of which an average of 9 pills are consumed1 HOPE-1 Study vs Estimated Opioid Usage With Current Practice Assumptions (n=93) Pills Prescribed Pills Consumed Pills Leftover Current practice estimates 2790 837 1953 HOPE-1 results 90 33 57 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)November 15, 2018 Potential Impact if HOPE-1 Extrapolated to the ~800,0002 Inguinal Hernia Surgeries Annually Pills Prescribed Pills Consumed Pills Leftover Current Practice Estimates 24,000,000 7,200,000 16,800,000 HOPE-1 Estimates 774,194 283,871 490,323 Potential Reduction with HTX-011 + OTC 23,225,806↓ 6,916,129↓ 16,309,677↓ 2. Decisions Resources Group claims data 2017 ; HTX-011 is an investigational new drug and not approved by the FDA

Phase 2b Total Knee Arthroplasty (TKA) (Study 209) Study 209 Follow-on: HTX-011 + MMA in TKA* (Study 306) *The multimodal analgesic (MMA) regimen used in this study was identical to the PILLAR Study of liposomal bupivacaine

Study 209 TKA: Results Hierarchy AUC0-48 HTX-011 400 mg vs. Placebo AUC0-72 HTX-011 400 mg+ Ropivacaine vs. Placebo AUC0-48 HTX-011 400 mg + Ropivacaine vs. Placebo p < 0.0001 AUC0-72 HTX-011 400 mg vs. Placebo p = 0.0002 p < 0.0001 p = 0.0004 HTX-011 via instillation achieved primary and key secondary endpoints for reduction in pain intensity scores HTX-011 is an investigational new drug and not approved by the FDA

Study 209 TKA: HTX-011 Produced Significantly Superior Pain Reduction to Both Placebo and Bupivacaine Through 72 Hours Notes: Pain intensity collected using Numeric Rating Scale (NRS) LOCF for missing data and no adjustment for use of opioid rescue medication HTX-011 is an investigational new drug and not approved by the FDA

Study 209 Follow-on: HTX-011 + Generic Analgesics* Kept Pain in the MiId Range Through 72 Hours With 68% Less Opioid Than Bupivacaine HTX-011 is an investigational new drug and not approved by the FDA LOCF for missing pain data 1 4 8 * Patients received oral acetaminophen 975 to 1000 mg every 8 hours (maximum 3000 mg/d) and oral celecoxib 200 mg every 12 hours until discharge. Mont doi: 10.1016/j.arth.2017.07.024 Severe Pain Mild Pain

Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study (Dysart 2019) Cross-Study Comparison of 0 – 24 Hour Results in TKA Using Pillar-Based MMA and the Same Analysis1 Study 306  HTX-011 (N=51) PILLAR Study Exparel + Bupivacaine1 (N = 70) Bupivacaine1  (N = 69) AUC0-24 VAS Pain 2 59.5 98.5 121.6 Opioid-Free 21.6% 17.1% 1.4% Mean Opioid Consumption MME (SD) 10.6 (9.2) 45.5 (35.01) 56.8 (38.26) Log-transformed Geometric Mean Opioid Consumption MME 0.54 3.5 38.5 Discharge Ready in 12 hours Based MPADSS > 9 60.8% 42.9% 27.5% https://doi.org/10.1016/j.arth.2018.12.026. Assumes LOCF as publication does not describe any correction for opioid use Disclaimer This is a cross-study comparison of Study 306 to the PILLAR Study of Exparel plus bupivacaine; these comparisons do not imply a clinical benefit of HTX-011 over Exparel HTX-011 is an investigational new drug and not approved by the FDA

Cross-Study Comparison of 48 Hour Results From Study 306 (Preliminary Results) and Exparel Pillar Study (Mont 2017) Comparison of 48 Hr Results in TKA Using Pillar-Based MMA and the Same Analysis1 Study 306  HTX-011 (N=51) PILLAR Study Exparel + Bupivacine1 (N = 70) Bupivacaine1  (N = 69) Mean AUC12-48 VAS Pain 143.2 180.8 209.3 Opioid-Free 11.8% 10% 0% Mean Opioid Consumption (MME ) 19.6 ( Median=16.7) Not Shown Not Shown Log-transformed Geometric Mean Opioid Consumption MME 3.0 18.7 84.9 < 20 MME @ 48 hr 56.9% 18.6% 4.4% > 20 and < 220 MME @ 48hr 43.1% 78.6% 87% > 220 MME @ 48 hr 0 2.9% 8.7% DID NOT Receive a Discharge Prescription for Opioids 74.5% Not Shown Not Shown 1. Mont doi: 10.1016/j.arth.2017.07.024 Disclaimer This is a cross-study comparison of Study 306 to the PILLAR Study of Exparel plus bupivacaine; these comparisons do not imply a clinical benefit of HTX-011 over Exparel HTX-011 is an investigational new drug and not approved by the FDA

Potential Reduction of Discharge Opioids Based on Study 306 Currently, following TKA an average of 90 opioid pills are prescribed per patient at the time of discharge, with an additional 4 refills over the next year1 Potential Impact on Discharge Opioids of Study 306 Extrapolated to the 1,043,000 TKA Surgeries Annually2 Pills Prescribed Current Practice Estimates With Initial Rx 93,870.000 Study 306 Results (25.5% only) 23,936,850 Potential Reduction with HTX-011 + MMA 69,933,150↓ Truven Database – Commercial patients Decisions Resources Group claims data 2018; HTX-011 is an investigational new drug and not approved by the FDA

Safety Summary HTX-011 was generally well tolerated across all Phase 2 and Phase 3 studies with no clinically meaningful differences from placebo and bupivacaine in: Overall adverse events The incidence of serious adverse events Premature discontinuations due to adverse events Potential local anesthetic systemic toxicity (LAST) adverse events Potential wound healing related adverse events No deaths on HTX-011 (one on bupivacaine) HTX-011 is an investigational new drug and not approved by the FDA

HTX-034 Development Next Generation Product for Postoperative Pain

Local tissue damage activates a variety of cells, which release inflammatory mediators1,2 References: 1. Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140(6):441-451. 2. Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009;139(2): 267-284. In Addition to Changes in pH, Inflammation From Surgery Modifies Pain Pathways and Can Produce Hyperalgesia Nociceptor Receptors Peripheral mediators of inflammation Inflammation Mediators Macrophage Mast cell Tissue damage Immune cells Platelets Substance P CGRP HTX-034 is an investigational new drug and not approved by the FDA

HTX-034 Produces Complete Elimination of Pain Through 7 Days in Pig Postoperative Pain Model HTX-011 & HTX-034 are investigational new drugs and not approved by the FDA This validated pig model of postoperative pain has been predictive of clinical observations with HTX-011, HTX-002 and HTX-009

CINV Commercial Products

With CINVANTI Leading the Way, Heron’s CINV Portfolio Achieved 2019 Net Sales of $145.7M, an 88% Increase from 2018 CINV portfolio net sales by quarter Launch of generic Emend IV in September resulted in a small decline in CINVANTI sales in 4Q Clinic-based practices are much faster to take advantage of the arbitrage SUSTOL sales declined in 4Q due to the Refresh Program; sales should return in 1Q2021

CINVANTI – Hospital Share/Units Continued to Grow in 4Q2019 SOURCE: 867 1.8.20, IMS DDD 12.27.19

CINVANTI – Clinic Share/Units Declined in 4Q2019 Due to the Emend IV Arbitrage SOURCE: 867 1.8.20, IMS DDD 12.27.19

CINVANTI Maintains Market Leadership 15 Weeks After the Launch of Multiple EMEND IV Generics Source: IMS DDD 12.20.19

Strategy to Preserve CINVANTI Through Generic Arbitrage Leverage favorable 340B pass through status, ASP+ 6% through 2020 IV push sNDA approved further differentiating CINVANTI from Emend and generics Practices are staying with CINVANTI due to the improved safety profile they have observed CINVANTI has become an established brand across both clinics and hospital capturing 45% of the market in Q3 2019

Branded ALOXI/Palonosetron Arbitrage Lasted Much Longer Than Projected, Resulting in an Accelerated Decline in Sustol ASP Even with multiple generics on the market, the price of palonosetron did not drop as quickly as in past arbitrage periods Slow decline in prices resulted in a very long arbitrage, which also resulted in an accelerated decline in the Sustol ASP The only way to rebuild value in the brand is to implement an innovative strategy: Starting October 1, all discounting of Sustol was discontinued, which will result in lower sales In approximately 5 quarters the ASP of Sustol will reset to approximately the WAC Sustol will be re-launched with enhanced value for practices and Heron

2020 CINV Franchise Outlook CINVANTI® Cinvanti continues to have the best overall profile compared to the other available NK1 antagonists and is completely differentiated from generic fosaprepitant with the 2-min IV Push administration CINVANTI (aprepitant) injectable emulsion received unique J-Code J0185 effective January 1, 2019, so generic pricing does not effect Cinvanti reimbursement Generic fosaprepitant IV entered the market in September 2019 Due to significant sales in 340b hospitals, IV push label and other factors, we expect to maintain XX% of our market during the arbitrage Based on early price reductions within weeks of the first generic entry, the duration of the arbitrage should also be shorter than with Aloxi and essentially be over by the end of 2020 SUSTOL® To recover from the protracted palonosetron arbitrage, Heron has implemented an innovative strategy to refresh the ASP This will result in greatly reduced sales for approximately 5 quarters, followed by a significant rebound in units and revenue. CINV Franchise 2019 net product sales: ~$145.7M 2019 guidance: $115M - 120M raised to $135M 2020 net sales guidance for CINV franchise will be provided after 1Q2020 when the impact of the arbitrage is known

Financial Summary Summary Statement of Operations and Net Cash Used in Operations (In thousands, except per share data) Three Months Ended September 30, 2019 Nine Months Ended September 30, 2019 Net product sales $ 42,624 $ 110,885 Operating expenses1 77,477 262,217 Other income, net 1,258 4,503 Net loss1 $ (33,595) $ (146,829) Net loss per share2 $ (0.42) $ (1.85) Net cash used in operations $ (25,471) $ (97,603) Condensed Balance Sheet Data (In thousands) September 30, 2019 Cash, cash equivalents and short-term investments (see note above) $ 256,278 Accounts receivable, net $ 66,955 Total assets $ 392,962 Total stockholders’ equity $ 285,442 Common shares outstanding at September 30, 2019 totaled 80.0 million. Adjusting for our October 2019 public offering of common stock, as of September 30, 2019, pro forma common shares outstanding totaled 89.9 million. 1 Includes $9.7 million and $40.3 million of non-cash, stock-based compensation expense for the three and nine months ended September 30, 2019, respectively. 2 Based on 79.9 million and 79.3 million weighted-average common shares outstanding for the three and nine months ended September 30, 2019, respectively. Heron ended 2019 with cash, cash equivalents and short-term investments of ~$391 million.

Key Catalysts in Pain Management & CINV Franchises HTX-011 & HTX-034 for Postoperative Pain CINVANTI ® and SUSTOL® for CINV Revised NDA submitted 26 Sep 2019 addressing CRL New PDUFA date: 26 March 2020 EU MAA filing by Centralised Procedure in March 2019 Potential CHMP opinion 2Q2020 Canadian NDS screening completed Potential approval in early 3Q2020 2020 net sales guidance for CINV franchise will be provided after 1Q2020 when the impact of the arbitrage is known HOPE Project launched across the US Publication of Phase 3 and Phase 2b studies Phase 3 studies published in peer-reviewed journals EPOCH 1: Reg Anesth Pain Med. 2019;0:1–7. doi:10.1136/rapm-2019-100531 EPOCH 2: Hernia. doi: 10.1007/s10029-019-02023-6. Phase 2 with HTX-034 planned for 1Q2020 HTX-011 & HTX-034 are investigational new drugs and not approved by the FDA