Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Q4 2021 Earnings Presentation
26 slides from Heron Therapeutics's earnings presentation, March 2022
Slide 1: Heron Update Q4 2021 Earnings Call
Heron Update Q4 2021 Earnings Call
Slide 2: Forward-Looking Statements
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
Slide 3: Heron Pipeline
Heron Pipeline PRECLINICAL CLINICAL NDA APPROVED SUSTOL® (granisetron) US FDA Approved for CINV Prevention* Oncology Care extended-release injection CINVANTI® (aprepitant) US FDA Approved for CINV Prevention* injectable emulsion ZYNRELEF® (bupivacaine and meloxicam) US FDA Approved for postsurgical
Slide 4: Successful FDA Interactions Resulted in Expansion of ZYNRELEF Label
Successful FDA Interactions Resulted in Expansion of ZYNRELEF Label • In a little over two months from submission, the FDA approved our supplemental NDA to significantly expand ZYNRELEF indications to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplast
Slide 5: Activities Needed for sNDA #2 to Obtain Broadest Label Underway
Activities Needed for sNDA #2 to Obtain Broadest Label Underway • Study 220 C-section: enrollment completed • Study 221 Spine: recruiting • AMAZE Study: – Abdominoplasty – enrollment completing – Shoulder – recruiting • sNDA #2 on target for 2H2022 5 Please see IMPORTANT SAFETY INFORMATION on pages
Slide 6: ZYNRELEF Commercial Update Q4 2021
ZYNRELEF Commercial Update Q4 2021 Earnings Call
Slide 7: ZYNRELEF Launch Highlights
ZYNRELEF Launch Highlights Continue to gain formulary approvals in targeted Hospitals and IDNs Building unique ordering accounts with increases in reordering rates Significant growth in demand units quarter over quarter Expanded label is already increasing our opportunity with current users Meaningf
Slide 8: ZYNRELEF Continues to Gain Rapid Formulary Approvals
ZYNRELEF Continues to Gain Rapid Formulary Approvals ZYNRELEF formulary approvals: 260 as of February 25, 2022 Over 90% P&T Committee approval rate in hospitals Formulary Approval Status Estimated % of Approvals Unrestricted Usage 65% Restricted (Primarily for Indicated Procedures) 35% Over 100 addi
Slide 9: Targeting IDNs – Top Down Strategy Creating New Opportunities
Targeting IDNs – Top Down Strategy is Creating New Opportunities for Therapeutic Interchange 34 IDNs have added ZYNRELEF as formulary approved product Represent 186 hospitals and 82 ASCs – many hospitals still require formulary approval 41% unrestricted / 59% restricted formulary approvals 34 IDNs r
Slide 10: ZYNRELEF is Gaining Significant Traction in COVID Era
ZYNRELEF is Gaining Significant Traction in COVID Era 309 unique accounts ordered ZYNRELEF (July 2021 – December 2021) ZYNRELEF Reordering Account rate has grown from 50% in first 3 months Unique Ordering Accounts* Reordering Account Rate* 6 Months Post Launch 6 Months Post Launch 372 73% 309 53% 48
Slide 11: ZYNRELEF is Rapidly Increasing Monthly Demand Volume
ZYNRELEF is Rapidly Increasing Monthly Demand Volume 401 unique ordering accounts during first 8 months of launch Grew demand unit sales +126% from Q3 21 to Q4 21 400mg SKU represents 77% of demand since launch +126% FDA Label +42% Expansion 5,176 2,916 400MG 400MG 2,041 2,060 200MG 200MG 1,774 4,11
Slide 12: Expanded Indications Will Grow ZYNRELEF Use in THA Patients
Expanded Indications Will Grow ZYNRELEF Use in THA Patients Yes No ARE YOU CURRENTLY USING ZYNRELEF WITH 99% 1% YOUR PATIENTS? IF YES, DID YOU USE ZYNRELEF IN THA PRIOR 29% 71% TO THE EXPANDED INDICATION? ARE YOU CURRENTLY USING ZYNRELEF IN THA 48% 52% PATIENTS? IF NO, DO YOU PLAN ON USING ZYNRELEF
Slide 13: Meaningful Progress Burning through Initial DC Inventory
Meaningful Progress Burning through Initial DC Inventory Q4’21 Net Sales: $844k Q4 Net Sales decreased vs. prior quarter of $2.1M as initial stocking inventory was drawn down based on demand orders ZYNRELEF has established nationwide access through broad distribution channel stocking 85 distribution
Slide 14: ZYNRELEF Reimbursement Advantages
ZYNRELEF Reimbursement Advantages Multiple Commercial and Medicaid payers covering >120 million lives have agreed to reimburse ZYNRELEF outside of the surgical DRG bundled payment in the ASC Many of these covered lives are also reimbursed separately in the HOPD ZYNRELEF’s lower price benefits all se
Slide 15: ZYNRELEF Priorities 2022
ZYNRELEF Priorities 2022 Leverage new label indication for faster growth Expand beyond TKA, Hernia and Bunion in unrestricted accounts Expand / remove restrictions in formulary approved accounts Revisit “Therapeutic Interchange” accounts with expanded label Build consistent usage in formulary approv
Slide 16: Oncology Care Franchise Q4'21 Review
Oncology Care Franchise Q4’21 Review
Slide 17: CINV Franchise 2021 Results
CINV Franchise 2021 Results • Q4’21 CINV Franchise net product sales were $19.9 million • Solid 2021 performance despite headwinds remaining in the CINV market – Reduction in the clinic anti-emetic market was due to COVID-related decreases in cancer screening and patient visits – OCM and value-based
Slide 18: Heron's CINV Portfolio Net Sales Stabilized in Markets Dominated by Generics
Heron’s CINV Portfolio Net Sales Stabilized in Markets Dominated by Generics during 2021, Poised for Growth in 2022 • CINVANTI demand unit sales stabilized in 2021 maintaining 98% of 2020 levels • SUSTOL sales rebounded in 2021 following the Refresh Program CINVANTI SUSTOL $25.4M CINV portfolio net
Slide 19: CINV Franchise 2022 Outlook
CINV Franchise 2022 Outlook • Sales for CINVANTI and SUSTOL are poised for moderate growth in 2022 based on improving reimbursement tailwinds – Generic fosaprepitant ASP reimbursement decreased to $28.50 in Q1’22 (decrease of 44% from Q2’21) – Effective January 1, 2022 – separate reimbursement for g
Slide 20: Heron's Commercial Strategy
Heron’s Commercial Strategy Establish Heron as a leading company in Acute Care • ZYNRELEF is off to a fast start and growing rapidly • Growth will accelerate with ZYNRELEF’s label expansion • Expand Acute Care footprint with HTX-019 for PONV in Q4’22, if approved Return Growth and Maximize Profitabi
Slide 21: HTX-019 for Postoperative Nausea and Vomiting (PONV)
HTX-019 for Postoperative Nausea and Vomiting (PONV) NDA Submitted November 2021 21 HTX-019 is an investigational new drug for PONV and not approved by the FDA
Slide 22: HTX-019 for PONV
HTX-019 for PONV • PONV is a large market ~25x the size of CINV • HTX-019 has significant potential advantages over oral aprepitant and IV fosaprepitant: – Therapeutic plasma concentrations where ≥97% receptor occupancy in the brain would be predicted are achieved in minutes versus >1 hour for oral
Slide 23: Oral Aprepitant is Already Rapidly Growing with No Promotion
Oral Aprepitant is Already Rapidly Growing with No Promotion, Product Limitations and High Acquisition Cost Initial HTX-019 target in 2023 For Therapeutic Substitution 637k Oral Aprepitant – 40mg Units 509k 408k 299k 300k COVID 220k +25% 2022-2023 Projected Totals at 25% 135k growth 2017 2018 2019 2
Slide 24: Financial Summary
Financial Summary Heron had cash, cash equivalents and short-term investments of $157.6 million as of December 31, 2021. We expect net cash used for operating activities of $44 million to $48 million in the first quarter of 2022, and we anticipate that our net cash usage will continue to moderate lo
Slide 25: 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 N
Slide 26: Important Safety Information for Patients (cont)
Important Safety Information for Patients (cont) The most common side effects of ZYNRELEF are constipation, vomiting, and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may reduce the effects of some blood pressure medications;