Full Press Release Details
Approval May 13, 2021 Exhibit 99.2
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: risks associated with achieving the full-year 2021 net product sales guidance for the CINV franchise; the timing of the commercial launch of ZYNRELEF in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the timing and results of studies for HTX-011, the HTX-034 development program, and the HTX-019 development program; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations; the extent of the impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our business; 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.
Forward-Looking Statements
Heron Pipeline US FDA Approved for postsurgical analgesia for up to 72 hours* ZYNRELEF
(bupivacaine and meloxicam) extended-release solution Acute Care 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 agentsis 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 has not been studied for treatment of established nausea and vomiting. ZYRNELEF (bupivacaine and meloxicam) extended-release solution is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Under Investigation for Postoperative Pain HTX-034
(bupivacaine/meloxicam/aprepitant)
HTX-034 and HTX-019 are investigational new drugs and are not approved by the FDA SUSTOL (granisetron) extended-release injection Oncology Care US FDA Approved for CINV Prevention* HTX-019 (aprepitant) injectable emulsion
In 2020, drug overdoses were linked to more than
the highest number ever recorded in a single year.3
Why Approval of ZYNRELEF is so Important Postoperative Opioids Can Be a Doorway to Addiction > 2 million Americans
may become persistent opioid users annually after surgery. 1 More than 50 million
surgical procedures happen in the United States.1
67% of patients filled an opioid prescription between 30 days before through 14 days after surgery.2*
In addition, most patients take fewer opioids than the amount prescribed after surgery, resulting in excess opioid pills that are accessible to others.4 80% of patients report unused opioid tablets4 Up to 77% of opioid pills remain inside the home in unsecured locations4 51% of nonmedical users of opioids received them from friends and family5 References: 1. Brummett CM, Waljee JF, Goesling J, et al. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults [published correction appears in JAMA Surg. 2019 Mar 1;154(3):272]. JAMA Surg. 2017;152(6):e170504. doi:10.1001/jamasurg.2017.0504. 2. Santosa KB, Hu HM, Brummett CM, et al. New persistent opioid use among older patients following surgery: A Medicare claims analysis. Surgery. 2020;167(4):732-742. doi:10.1016/j.surg.2019.04.016. 3. NCHS, National Vital Statistics System. Estimates for 2020 are based on provisional data. Estimates for 2015-2019 are based on final data (available from: https://www.cdc.gov/nchs/nvss/mortality_public_use_data.htm). 4. Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017;152(11):1066-1071. doi:10.1001/jamasurg.2017.0831. 5. Substance Abuse and Mental Health Services Administration . Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; Rockville, MD: 2019. Key Substance Use and Mental Health Indicators in the United States: Results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEP19-5068, NSDUH Series H-54). https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf. Accessed April 19, 2021. 6. Brummett CM, Evans-Shields J, England C, Kong AM, Lew CR, Henriques C, Zimmerman NM, Sun EC. Increased health care costs associated with new persistent opioid use after major surgery in opioid-naive patients. J Manag Care Spec Pharm. 2021 Feb 24:1-12. doi: 10.18553/jmcp.2021.20507. Epub ahead of print. PMID: 33624534. More than $23.4 billion in annual healthcare costs associated with persistent opioid users can be attributed to postoperative pain management.1,6 * This was determined using a 20% national sample of Medicare claims among beneficiaries aged 65 and older with Medicare Part D claims who underwent a major or minor surgical procedure between January 1, 2009 and June 30, 2015.
ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF Approved Indications and Limitations of Use
ZYNRELEF is first modified-release local anesthetic to be classified by FDA as an "extended-release" product
ZYNRELEF only product to demonstrate superiority to immediate release bupivacaine HCL for 72 hours
72-hour duration in the indication statement
Registrational studies in clinical data section in indicated procedures include pain curves showing 72-hour duration of activity and superiority to standard of care
Focus is on opioid-free results in clinical data section as both statistically superior and clinically meaningful
Standard NSAID class warnings included, with modifications due to single-dose local application allowing for additional NSAID use in multimodal analgesia (MMA) with monitoring Unique Labeling Attributes for ZYNRELEF Extended-Release Solution
Rather than approving a broad indication based on 1 soft tissue and 1 bony surgical model, FDA approved other modified-release local anesthetics for specific indications based on positive randomized, controlled trials in specific surgical procedures starting in 2020.
Heron sought advice from FDA throughout development to discuss requirements for a broad label for ZYNRELEF, the only modified-release local anesthetic to demonstrate superiority to bupivacaine solution
Based on these discussions with FDA, Heron believed that the studies submitted in the ZYNRELEF NDA would be sufficient to obtain a broad indication
One week prior to PDUFA, FDA informed Heron more PK and safety data would be required to support additional surgical procedures
Heron has multiple studies in process intended to support expanded labelling FDA Approach to Modified-Release Local Anesthetics Changed Following Withdrawal of Guidance on Analgesic Indications
The Commercialization of ZYNRELEF Advancing Postoperative Pain Management May 2021
Executive Summary: Go-to-Market Strategy Strategic Imperatives Establish ZYNRELEF as a new class and best choice for postoperative pain Raise the bar with ZYNRELEF's superior value proposition to expedite access Highly focused targeting strategy to convert usage and accelerate sales
Strategic Imperative #1 Establish ZYNRELEF as a new class and best choice for postoperative pain
The first and only extended-release, dual-acting local anesthetic (DALA), keeping more patients out of severe pain and opioid-free for 72 hours after surgery1-3 Positioning References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021. 2. Viscusi E, Gimbel JS, Pollack RA, et al. Reg Anesth Pain Med. 2019;44(7):700-706. 3. Viscusi E, Minkowitz H, Winkle P, et al. Hernia. 2019;23(6):1071-1080.
Differentiating ZYNRELEF and Establishing A Reason to Believe for Clinicians: A Novel Mechanism of Action References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021. 2. Viscusi E, Gimbel JS, Pollack RA, et al. Reg Anesth Pain Med. 2019;44(7):700-706. 3. Viscusi E, Minkowitz H, Winkle P, et al. Hernia. 2019;23(6):1071-1080. 4. Ottoboni T, Quart B, Pawasauskas J, et al. Reg Anesth Pain Med. 2020;45(2):117-123. 5. LSSG Mechanic, 2018 ZYNRELEF is the first and only extended-release dual-acting local anesthetic (DALA).1-3
The synergistic combination of bupivacaine with low-dose meloxicam is designed to reduce local inflammation, thereby normalizing the pH and allowing considerably more bupivacaine to penetrate the cell membrane.1,4
The majority of physicians found ZYNRELEF's novel mechanism of action to be clinically relevant
It was viewed as a valuable differentiator when compared to Exparel, which does not target the local inflammatory process
ZYNRELEF Offers Superior Clinical Value Over Bupivacaine, Not Demonstrated with Exparel References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021. 2. Ottoboni T, Quart B, Pawasauskas J, et al. Reg Anesth Pain Med. 2020;45(2):117-123. 3. Viscusi E, Minkowitz H, Winkle P, et al. Hernia. 2019;23(6):1071-1080. 4. Viscusi E, Gimbel JS, Pollack RA, et al. Reg Anesth Pain Med. 2019;44(7):700-706. 5. Lachiewicz PF, Lee G-C, Pollak R, et al. J Arthroplasty. 2020;35(10):2843-2851. 6. DRG Pharmacy Director Surveys. Exparel Share is an early opportunity for ZYNRELEF > $400M in sales
Exparel has never demonstrated head-to-head superiority to bupivacaine
Exparel has efficacy challenges beyond 24 hours
Surveyed pharmacy directors state that they would provide better access to ZYNRELEF than to Exparel6
An Extensive Body of Peer-reviewed Data will be Available for Launch EPOCH 1 (301), RAPM-May 2019
EPOCH 2 (302), Hernia-Aug 2019
MOA (Inflammation and PK/PD), RAPM-Jan 2020
TKA (209), JoA-Oct 2020
Truven HEOR-opioid naive, JMCP-July 2019
Hernia (215), Surgery - Sept 2020
Bunion (218), JAPMA-Jan 2021
Truven HEOR, persistent users, JMCP-Feb 2021 MANUSCRIPTS Bunion (202, 208, 301, 218)
211 (Augmentation Mammoplasty)
220 (PK in breast milk and plasma concentrations)
Healthagen TKA/THA opioid use
All Studies-Lack of LAST (Cmax)
All Studies-Max Dose and Release Rates
HOPE Algorithm, HOPE Regimen and Patient Satisfaction POSTERS & ABSTRACTS Accepted for 2021 Congresses:
Safety with NSAID containing MMA
Safety with NSAID containing MMA in the elderly
HOPE Part 1 and 2 Combined
ZYNRELEF Is Well Positioned on Core Drivers to Create Fast Access and Early Uptake Importance of Core Attributes in Selecting a LA Top 2 Boxes Mean Product Rating on Core Attributes 1-5 Scale ZYNRELEF Exparel Bupivacaine On-Q 3 5 1 Source: Company-sponsored ATU Study July 2020 - Survey of 386 surgeons, anesthesiologists, pharmacists, NP/Pas of potential use of an approved product with the attributes for which ZYRELEF was developed
Targeting ~2.1M Procedures at Launch With Unprecedented Data Supporting Fast Uptake with Influential Specialties Reference: DRG Claims Analysis, 2019 / May 2021 DRG USPI Market Research. High value market procedures selected on severity and duration of pain and opioid use validated thorough medical review
Orthopedic and general surgeons account for 10.6M procedures or 76% of the 14M high value market procedures
Orthopedic and general surgeons account for 82% of Exparel market utilization
Orthopedic surgeons are heavy influencers (P&T, new drugs, profitability) across all settings of care Indicated Launch Targets Closely-Related Procedures Without Promotion Potential Combined Opportunity
$91M of Exparel 2019 Usage was in Our 3 Indicated Procedures References: 1. DRG Claims Analysis. 2. Exparel Sales - SHA Symphony Health - FY2019.
Strategic Imperative #2 Raise the bar with ZYNRELEF's superior value proposition to expedite access
ZYNRELEF's Unprecedented Value Proposition *Medicare Reimbursement only, pass-through status is for 3 years.
GPO = Group Purchasing Organization. HOPD = Hospital Outpatient Department. ZYNRELEF Go-to-Market Strategy Comparison
a. Heron will apply for transitional pass-through status for ZYNRELEF. Typically, pass-through status is for 3 years. b. Exparel (bupivacaine liposome injectable suspension) is a trademark of Pacira Pharmaceuticals, Inc. c. ZYNRELEF will be reimbursed at WAC + 3% until ASP is established. d. Effective January 1, 2019, ASCs are reimbursed at ASP + 6% for non-opioid postoperative pain management drugs, like ZYNRELEF, when administered during a surgical procedure.
HOPD: hospital outpatient department. AWP: average wholesale price. ASP: average selling price. ASC: ambulatory surgical center. WAC: wholesale acquisition cost. Heron will apply for a J-code to facilitate separate reimbursement with expected grant date of January 1, 2022
Like all new products, until CMS assigns a permanent code, commercial payers will require a miscellaneous code (J3490 or C9399) for ZYNRELEF
Heron Connect helps customers navigate coding and reimbursement for ZYNRELEF
Medicare: ZYNRELEF Is Reimbursed
Separately in HOPD and ASC Heron will apply for a C-Code with expected
grant date of October 1, 2021 Commercial Reimbursement Varies by Payer
ZYNRELEF Reimbursement & Pricing Creates Economic Benefits Across All Settings of Care
ZYNRELEF's Significant Economic Benefits Designed to Support Rapid Share Conversion and Broad Access *Comparing WAC acquisition cost to NCR reimbursement under Medicare/Exparel NCR assumes ASCs purchasing at WAC.
Medicare NCRs are shown based on estimated ASP reimbursement for ZYNRELEF and Exparel Q2'21 published ASP reimbursement.
WAC: wholesale acquisition cost. NCR: net cost recovery. HOPD: hospital outpatient department. ASC: ambulatory surgical center.
**DRG Research Pricing Research 2018 and Mock P&T Research 2019
ZYNRELEF Economic Benefit vs. Exparel* 340B accounts: >$415 (400 mg to 266 mg) and >$223 (200 mg to 133 mg)
HOPD accounts: >$354 (400 mg to 266 mg) and >$192 (200 mg to 133 mg)
Research has shown all customer segments were more sensitive to and favored acquisition cost over reimbursement** Does not include additional cost of bupivacaine to admix with Exparel to achieve efficacy
Ease of Use and Implementation Note: Kit components include single-dose glass vial, Luer lock syringe(s), vented vial spike, Luer lock applicator(s), and tip cap(s).
SKU: stock keeping unit.
References: 1. ZYNRELEF [instructions for use]. San Diego, CA: Heron Therapeutics Inc; 2021. 2. Mont MA, Beaver WB, Dysart SH, et al. J Arthroplasty. 2018;33(1):90-96. 3. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021. The needle-free application1
Avoids risks of inadvertent venous punctures and eliminates accidental needle sticks with local anesthetics1
Eliminates the need for up to 120 injections (as in total knee arthroplasty)2 and the time needed for aspiration and application No specialized training or certification required to administer ZYNRELEF via needle-free application1 Launching with 2 SKUs for different surgery requirements1
Reducing cost per procedure
Minimizing waste Room temperature storage1,3 Kits fit standard OR medication carts (eg, Pyxis ) and include all components
Strategic Imperative #3 Highly focused targeting strategy to convert usage and accelerate sales
High Performing and Focused Organization: Established Platform With Experienced Teams in Place Existing Platform Advantages We are prepared for the launch of ZYNRELEF. 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, Full-line wholesaler agreements and 3PL in place 89 New Hospital Sales Reps
OR Experience Pain Experience
Pull-Through Experience
A Proven Track Record of Hospital Launch Success Reference : Chargeback/867 5.5.2020, IMS DDD 5.1. 2020. Heron launched CINVANTI in January 2018
In a very short time period, we quickly achieved significant market share
Superior pricing and contracting
Providing 340B discount
Differentiated product attributes
Rapid formulary adoption
Accelerated account pull-through
Trade and reimbursement expertise 40.000 110.000 100.000 60.000 90.000 70.000 80.000 50.000 30.000 20.000 0 10.000 120.000 2019-Q1 2019-Q4 2019-Q2 66.773 2019-Q3 2018-Q2 2018-Q1 2018-Q3 2018-Q4 7.990 119.898 28.751 51.471 94.576 103.360 Hospital Units Hospital Share CINV Hospital Share/Units We will leverage the success and experience gained from CINVANTI as we enter the postoperative pain management landscape with ZYNRELEF.
Comparison of Successful Hospital Launches Source: Net product revenue & launch dates based on SEC filings Revenue $ Millions