Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (May 2021)
34 slides from Heron Therapeutics's corporate update, May 13, 2021
Slide 1: Approval May 13, 2021
Approval May 13, 2021 Exhibit 99.2
Slide 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 a
Slide 3: Heron Pipeline
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
Slide 4: Why Approval of ZYNRELEF is so Important
In 2020, drug overdoses were linked to more than 90,000 deaths 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
Slide 5: ZYNRELEF Approved Indications and Limitations of Use
Indication 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. Limitations of Use Safety and efficacy have not been established in highly vascu
Slide 6: Unique Labeling Attributes for ZYNRELEF Extended-Release Solution
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
Slide 7: FDA Approach to Modified-Release Local Anesthetics Changed Following Withdrawal
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 thr
Slide 8: The Commercialization of ZYNRELEF Advancing Postoperative Pain Management
The Commercialization of ZYNRELEF Advancing Postoperative Pain Management May 2021
Slide 9: Executive Summary: Go-to-Market Strategy
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 1. 2. 3.
Slide 10: Strategic Imperative #1: Establish ZYNRELEF as a new class
Strategic Imperative #1 Establish ZYNRELEF as a new class and best choice for postoperative pain
Slide 11: Positioning: First and only extended-release dual-acting local anesthetic
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
Slide 12: Differentiating ZYNRELEF: A Novel Mechanism of Action
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, Minkowit
Slide 13: ZYNRELEF Offers Superior Clinical Value Over Bupivacaine, Not Demonstrated with Exparel
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, e
Slide 14: An Extensive Body of Peer-reviewed Data will be Available for Launch
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
Slide 15: ZYNRELEF Is Well Positioned on Core Drivers to Create Fast Access
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 surgeo
Slide 16: Targeting ~2.1M Procedures at Launch
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
Slide 17: $91M of Exparel 2019 Usage was in Our Indicated Procedures
$91M of Exparel 2019 Usage was in Our 3 Indicated Procedures References: 1. DRG Claims Analysis. 2. Exparel Sales – SHA Symphony Health – FY2019.
Slide 18: Strategic Imperative #2: Raise the bar with superior value proposition
Strategic Imperative #2 Raise the bar with ZYNRELEF’s superior value proposition to expedite access
Slide 19: ZYNRELEF's Unprecedented Value Proposition
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
Slide 20: Reimbursement: Pass-Through Status and J-Code
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. Effecti
Slide 21: ZYNRELEF's Significant Economic Benefits
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
Slide 22: Ease of Use and Implementation
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, Beav
Slide 23: Strategic Imperative #3: Highly focused targeting strategy
Strategic Imperative #3 Highly focused targeting strategy to convert usage and accelerate sales
Slide 24: High Performing and Focused Organization: Established Platform
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 Success
Slide 25: A Proven Track Record of Hospital Launch Success
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 Flawless execution: Superior pricing and contracting Providing 340B discount Diff
Slide 26: Comparison of Successful Hospital Launches
Comparison of Successful Hospital Launches Source: Net product revenue & launch dates based on SEC filings Revenue $ Millions
Slide 27: Outpatient Growth is Anticipated to Accelerate Over the Next 3 Years
CMS will eliminate the Inpatient Procedure Only (IPO) list over 3 years starting in CY 2021 CMS has expanded the ASC-Covered Procedures List including Total Hip Arthroplasty CMS has eliminated their exclusion criteria leaving the determination of appropriate site of care to the physician Outpatient
Slide 28: ZYNRELEF Competitive Position Across Settings of Care
ZYNRELEF Competitive Position Across Settings of Care SKU: stock keeping unit. HOPD: hospital outpatient department. 1. Reference: 2019 DRG Claims Data: Procedures selected on severity and duration of pain and opioid use validated thorough medical review ~14M High Value Market Procedures1 OVERALL TO
Slide 29: Branded Product Utilization and Spending is ~$1B
Branded Product Utilization and Spending is ~$1B Despite Limitations of Current Products *Ofirmev sales decline with generic entries. †On-Q sales are estimated at ~$150M (down mid-single digits) 2019. Reference: SHA Symphony Health – FY2019-2020. $401M $80M $156M $389M 2020 $655M Generic Local Anest
Slide 30: 58% of Prioritized Target Accounts are Fast Moving
58% of Prioritized Target Accounts are Fast Moving *Includes Exparel and Offirmev. ASC: ambulatory surgical center. WAC: wholesale acquisition cost. References: 1. Symphony Drug Market – 2020. 2. LexisNexis Procedure Data August 2019 YTD. 340B % high value market Procedures Branded Utilization Accts
Slide 31: Heron Is Positioned to Execute a Blockbuster Launch for ZYNRELEF
Heron Is Positioned to Execute a Blockbuster Launch for ZYNRELEF Proven track record with hospital launch success Existing platform and highly experienced team to execute launch Shaped market on significant unmet need and opportunity Unprecedented clinical and customer value proposition, with signif
Slide 32: Important Safety Information for Patients
Important Safety Information for Patients Important Safety Information ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which: can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSA
Slide 33: Important Safety Information for Patients (cont)
Important Safety Information for Patients (cont) Please see full Prescribing Information, including Boxed Warning. The most common side effects of ZYNRELEF are constipation, vomiting, and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular
Slide 34: Financial Summary
Financial Summary Common shares outstanding as of March 31, 2021 totaled 91.4 million. 1 Includes $11.5 million of non-cash, stock-based compensation expense for the three months ended March 31, 2021. 2 Based on 91.4 million weighted-average common shares outstanding for the three months ended March