Heron Therapeutics
Update
January 11, 2021
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: adjustments to the preliminary fourth-quarter 2020 and full-year 2020 net product sales for the CINV franchise in connection with the completion of the financial closing procedures and an audit for the 2020 fiscal year; risks associated with achieving the full-year 2021 net product sales guidance for the CINV franchise; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the commercial launch of ZYNRELEF in 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 PONV 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.
2
Corporate Updates
Strong Financial Positioning
- Preliminary Q4 2020 net product sales for CINV franchise of ~$20.3 Million
- Preliminary full-year 2020 net product sales for CINV franchise of ~$88.3 Million
- Versus Guidance of $85 Million
- Full-year2021 net product sales guidance for CINV franchise of $130-$145 Million
- Preliminary 2020 year-end cash balance of ~$208.5 Million
Clinical/Regulatory Updates
- HTX-011 - New Drug Application for postoperative pain management is under review in the US
- May 12, 2021 PDUFA Date
- HTX-034 - Preliminary results from Phase 1b bunionectomy study shows pain reduction through 96 hours with 45.5% of patients opioid-free through day 15
- HTX-019 - Preliminary results from Phase 1 study of low dose IV injection demonstrated bioequivalence to approved oral aprepitant
3 | 40 mg dose for prevention of postoperative nausea and vomiting |
Investment Areas
Heron Pipeline
PRECLINICAL | CLINICAL | NDA | APPROVED | |||
CINV*
SUSTOL®
(granisetron) | US FDA Approved for CINV Prevention* |
extended-release injection |
Preliminary 2020 net product sales for CINV franchise of ~$88.3M
CINVANTI® | |
(aprepitant) | US FDA Approved for CINV Prevention* |
injectable emulsion | |
PONV* | HTX-019 |
(aprepitant) | |
injectable emulsion |
IND active for PONV | NDA planned for 4Q2021 |
BE Demonstrated to Oral Aprepitant | |
▪ Fast Track and Breakthrough Therapy
MANAGEMENT | HTX-011 |
(bupivacaine/meloxicam) | |
HTX-034 | |
(bupivacaine/meloxicam/ | |
PAIN | |
aprepitant) | |
Marketing Applications Under Review in the U.S.
and Canada, and Approved in EU
Under Investigation for
Postoperative
Pain via Local Application
designations granted by FDA
- US NDA: resubmitted 11/12/2020; PDUFA goal date 05/12/2021
- Exposure data for excipients submitted to support reproductive toxicology studies; impurity specification lowered
- No issues related to clinical efficacy or safety, or manufacturing
-
EU MAA: ZYNRELEF™ Authorized by
European Commission
*CINV: Chemotherapy-induced nausea and vomiting. SUSTOL® (granisetron) extended-releaseinjection 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 | |
4 | 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. |
HTX-011,HTX-034 and HTX-019 are investigational new drugs and are not approved by the FDA
NDA Resubmitted Based on Guidance at Type A
Meeting
- Pharmacokinetic data generated for 3 excipients in toxicology animals and patients receiving HTX-011 400 mg in TKA and C-section studies
- Cmax of excipients at doses administered in reproductive toxicology studies are >50- to >200-fold higher than observed in patients receiving highest dose of HTX-011
- Substantially higher exposures observed in toxicology species validates acceptability of submitted studies
- Submitted pharmacokinetic data expected to address 3 of the 4 issues in CRL
- Fourth CRL issue addressed by lowering impurity specification for final drug product to FDA agreed upon level
- FDA has acknowledged Class 2 resubmission with 6-month review clock: PDUFA goal date of 05/12/2021
5
DMSO: Animal Pharmacokinetics (PK) vs Human Plasma
Levels in TKA Study
DMSO Cmax in toxicology animals 106- to 129-fold higher than humans
Animal PK NOAEL Dose Level | Human PK (HTX-011 400 mg) |
6 | Note: Mean Plasma Concentration Time Profiles of DMSO in Pregnant Rats and Rabbits (1,000 mg/kg/day DMSO via Oral |
Administration) and in Humans (HTX-011 400 mg/12 mg via Installation into the Surgical Site) |
Maleic Acid: Animal Pharmacokinetics vs Human Plasma
Levels in TKA Study
Maleic Acid Cmax in toxicology animals >50-fold higher than humans
Rabbit PK NOAEL Dose Level | Human PK (HTX-011 400 mg) |
7 | Note: Mean Plasma Concentration Time Profiles of Maleic Acid in Pregnant (20 mg/kg/day Maleic Acid via Oral Administration) and in Humans |
(HTX-011 400 mg/12 mg via Installation into the Surgical Site) | |
Triacetin: Animal Pharmacokinetics vs Human
Plasma Levels in TKA Study
Triacetin Cmax in toxicology animals >200-fold higher than humans
Rat PK NOAEL Dose Level | Human PK (HTX-011 400 mg) |
Note: Mean Plasma Concentration Time Profiles of Triacetin in Rats (1,000 mg/kg Triacetin via Oral Administration) and in Humans (HTX-011 | |
8 | 400 mg/12 mg via Installation into the Surgical Site) |
HTX-011 Commercialization
Advancing Pain Management
9 | HTX-011 is an investigational new drug and not approved by the FDA |
Established Platform With Experienced Teams in Place
We are prepared for the potential launch of HTX-011. Critical teams are already
in place, with extensive experience in successful hospital launches.
Payer | ||
GPO | Key Account | |
Management | ||
Trade and | Backbone |
Distribution | Infrastructure |
Commercial | |
Leadership | |
Regulatory | Medical |
and | Science |
Compliance | Liaisons |
Pharmaco- | Marketing |
vigilance | and Sales |
10
Existing Platform Advantages
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 launch
A Proven Track Record of Hospital Launch Success
Achieved >40% Market Share From Entrenched Competitor
- Heron launched CINVANTI in January 2018
- Achieved significant market share, in a very short time period
- Outstanding execution:
- Superior pricing and contracting
- Providing 340B discount
- Differentiated product attributes
- Rapid formulary adoption
- Accelerated account pull-through
- Trade and reimbursement expertise
CINV Hospital Share/Units | |||
120.000 | 119,922 | ||
110.000 | Hospital Share | ||
100.000 | Hospital Units | 102,990 | |
90.000 | 88,228 | ||
80.000 | |||
70.000 | 66,983 | ||
60.000 | 43% | ||
50.000 | 52,906 | 37% | |
32%
40.000
We will leverage the success and experience gained from CINVANTI as we enter the postoperative pain management landscape with HTX-011.
26%
30.000 | 28,178 | 21% | |
20.000 | |||
10.000 | 8,832 | 12% | |
307 4%
0
2018-Q1 | 2018-Q2 | 2018-Q32018-Q42019-Q12019-Q2 | 2019-Q32019-Q4 |
11 Source: IMS DDD12.25.20, 867 1.5.21
HTX-011 Is Well Positioned on Core Drivers to Create
Fast Access and Uptake
Heron is positioned for a successful launch
- High Awareness with key formulary decision makers
- Outperforms both branded and generic competition on every important core attribute for a LA
- Reduction in Severe Pain
- Elimination of Opioid Discharge Prescriptions
- 72 Hour Duration
HTX-011 Aided Awareness P&T Decision Makers
93%
68%
Pharm* | C-Suite |
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 we are developing HTX-011
12 *Pharmacists were required to be involved in formulary decisions to qualify for the survey
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 Is Well Positioned on Core Drivers to Create
Fast Access and Uptake
Importance of Core Attributes in Selecting a LA
Top 2 Boxes
Reduction in severe postoperative pain | 92% |
Ability to reduce or eliminate discharge | 84% |
opioid prescriptions | |
Ease of use / administration | 79% |
72-hour duration of effect | 73% |
Foundation for multi-modal analgesia | 62% |
Mean Product Rating on Core Attributes
1-5 Scale
On-Q | Bupivacaine | Exparel | HTX-011 |
4.1
4.0
4.1
4.2
3 | 3.9 | 5 |
Source: Company-sponsored ATU Study July 2020 - Survey of 386 surgeons, anesthesiologists, pharmacists, NP/Pas of potential use of an approved product with the
13 attributes for which we are developing HTX-011
HTX-011 is an investigational new drug and not approved by the FDA
Large Body of Peer-Reviewed Data for Launch
- Published Peer-Reviewed Manuscripts
- EPOCH 1 (301), Regional Anesthesia & Pain Medicine
- EPOCH 2 (302), Hernia
- Hernia Follow-on (215), Surgery
- EPOC TKA (209), Journal of Arthroplasty
- Mechanism of Action, Regional Anesthesia & Pain Medicine
- Truven HEOR (Opioid Naïve Users), Journal of Managed Care & Specialty Pharmacy
- Accepted for publication:
- Bunion (218), J. Am Podiatric Med Assoc (JAPMA)
- Truven HEOR, JMCP (Persistent Opioid Users)
- 38 posters and abstracts have been accepted and presented at key
Congresses*
*Includes congress publications from 2016-2020 based on Preclinical and Phase 2 studies (2016-2017) and Phase 3, Phase 3 Follow-On and Retrospective studies (2018-2020). 2020 congress publications include video/audio presentations at virtual congresses.
14 | HTX-011 is an investigational new drug and not approved by the FDA |
In 2019 Branded Use Grew to Over $1B, however, 2020 has been Impacted by COVID 19
$1,693M | |
Local Anesthetics | |
$63M | |
On-Q | $143M |
Exparel | $403M |
Ofirmev$472M
$ 1 Billion
in Branded Drug Utilization +14%
COVID IMPACT: FY 20 vs 19 | ||||
Product | Pack | % | WAC | % |
Units | Change | Change | ||
Bupivacaine | 14.7M | 11% | $31.7M | 12% |
Ropivacaine | 1.9M | 7% | $48.5M | 40% |
Exparel | 1.3M | -4% | $386.7M | -4% |
OFIRMEV | 8.4M | -23% | $400.3M | -15% |
Opioids | 150.7M | -3% | $649.1M | 6% |
Opioids$612M
2019
On-Q sales are estimated at ~$150M (down mid-single digits) / Avanos Earnings Call 11/05/19
15 Source: SHA Symphony Health Drug Data FY 2019, SHA Symphony Health Drug Data through 12-25-2020 - FY data forecasted
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 Competitive Position Across Settings of Care
14 | Hospital Inpatient 47% |
(6.6M procedures) | |
MILLION | • Bundled in DRG |
Target | |
• 56% (3.7M) of inpatient | |
Procedures | |
procedures are done in | |
340B hospitals |
OVERALL TOTAL
Hospital Outpatient 43% (6.0M procedures)
-
16% (1.0M) have Medicare reimbursement
(3-yearpass-through) - 57% (3.4M) eligible for
340B discount - Multiple SKUs - lower average costs
Ambulatory Surgical Centers 9% (1.3M procedures)
-
17% (0.2M) eligible for Medicare reimbursement
at ASP + 6% - Multiple SKUs - lower average costs
- HTX-011has lower acquisition cost benefit over bundled branded products
- Only HTX-011 will have HOPD reimbursement - 3-year pass-through
- Only HTX-011 will offer 340B pricing
52% of the opportunity lends itself to favorable reimbursement and access
Source: Heron estimate for procedure volume by site of care based on 2018 DRG Claims (data 2017) / DRG revised Claims Data 2020 (data 2017).
16 | HTX-011 is an investigational new drug and not approved by the FDA |
Market Dynamics are Shifting in Favor of HTX-011 and Will Accelerate Outpatient Growth
New CMS OPPS* Rules
- CMS will eliminate the Inpatient Procedure Only (IPO) list over 3 years starting in CY 2021
- In CY 2021 266 musculoskeletal-related procedures will be removed from (IPO)
- CMS will continue to package non-opioid pain management products in the hospital outpatient setting but products will remain unpackaged in ASC setting at ASP plus 6 percent.
- CMS indicated they will consider outpatient unbundling with real world peer reviewed evidence of opioid prescription elimination
HOPD* | ASC | |
Reimbursement | Reimbursement | |
Market Size | ~6.0M Procedures | ~1.3M Procedures |
HTX-011 | YES | YES |
3 year pass-through | ||
Exparel | NO | YES |
*OPPS: Outpatient Perspective Payment System, HOPD: Hospital Outpatient Department
Source: Heron estimate for procedure volume by site of care based on 2018 DRG Claims (data 2017) / DRG revised Claims Data 2020 (data 2017).
17
HTX-011 is an investigational new drug and not approved by the FDA
Impact of Previous CMS Rule Change on TKA
Outpatient Moved from 4% of TKA Procedures to 46% in Less Than 3 Years
120 | |||||||||
January 1, 2018 CMS | |||||||||
100 | 98% | removes TKA from IPO list | |||||||
80 | 84% | ||||||||
74% | |||||||||
60 | |||||||||
54% | |||||||||
46% | |||||||||
40 | |||||||||
26% | |||||||||
20 | 16% | ||||||||
2% | |||||||||
0 | |||||||||
20 | 18 | 9 | 2020 YTD | ||||||
2017 | 2018 | 2019 | 2020 | ||||||
Inpatient | Outpatient | ||||||||
18 Source: LexisNexis Procedure data full year 2017, 2018, 2019, 2020 data January - 12/27/20
HTX-011 is an investigational new drug and not approved by the FDA
Physicians and Pharmacists Surveyed Believe HTX-011 Will Grow the Local Anesthetics Market
With the option of using Product Z available, respondents preferred using a local anesthetic 7% more of the time across their procedures
% of time LA used - all procedures
84%
77%
Product Z
in Combo
Product Z
Alone
Pre-HTX-011 | With HTX-011 |
All Procedures
Across all 4 specialty groups, respondents
indicate a preference for using HTX-011 (either alone or in combination*) in ~60% of procedures.
HTX-011 Usage by Specialty Group
62% | 62% | 61% | 56% |
22% | 24% | 18% | 23% |
40% | 38% | 43% | 33% |
Soft tissue | Plastic | OB/GYN | Ortho |
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 we are developing HTX-011
19 * Used in combination with other local anesthetics (LA); for example, where another LA is used as a nerve block
HTX-011 is an investigational new drug and not approved by the FDA
Highly Focused Launch Approach: Targeting the Top 2 Specialties - Orthopedics and General Surgeons
~14M Target Procedures
Initial Targets
Highest-volume procedures in 2 major specialties
- ~6.0M Orthopedic procedures
- ~4.5M General surgery procedures
- ~2.6M OB/GYN procedures
- ~900K Plastic surgery procedures
- Ortho and general surgeons account for 10.5M procedures or 75% of the 14M initial targets
- Ortho and general surgeons account for 82% of Exparel market utilization
- Ortho surgeons are heavy influencers (P&T, new drugs, profitability) across all settings of care
Source: DRG Claims Analysis, 2016 and 2019
20 | HTX-011 is an investigational new drug and not approved by the FDA |
General Surgeons: HTX-011 Expected to Take Share from Other Treatment Options, With the Most Significant Being from Generic LAs
Anticipated Local Anesthetic Use - Soft Tissue Procedures
5%
8%
3%
4%
21%
66%
Pre HTX-011
9% | Personal Mix | |
On-Q | ||
22% | Exparel | ||
62% | Generic LAs | ||
HTX-011 | |||
Post HTX-011
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 we are developing HTX-011
21
HTX-011 is an investigational new drug and not approved by the FDA
Orthopedic Surgeons: HTX-011 Expected to Take Share from Other Treatment Options, With the Most Significant Being from Generic LAs
Anticipated Local Anesthetic Use - Orthopedic Procedures
3% | |||||
6% | |||||
5% | 11% | 10% | Personal Mix | ||
On-Q | |||||
18% | 66% | 26% | 56% | Exparel | |
Generic LAs
HTX-011
Pre HTX-011 | Post HTX-011 |
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 we are developing HTX-011
22
HTX-011 is an investigational new drug and not approved by the FDA
Across All Customers Surveyed, HTX-011 is Expected to Take Share from Both Exparel and Generic LAs
Usage of Products Pre/Post HTX-011 Introduction
(All Procedures) | ||
9% | 4% | |
Personal Mix | 3% | |
4% | On-Q | 10% |
Exparel
21%
26%
Generic LA
66%
HTX-01158%
Pre HTX-011 | Post HTX-011 |
While generic LA usage appears to decline by 40 percentage points, 40% of HTX-011 preference includes use in combination with another local anesthetic - the majority of which will be generic LAs.
% of HTX-011 Usage Alone vs. In Combo
HTX-011
Combo
40%HTX-011 alone
60%
23 | Source: Company-sponsoredATU Study July 2020 - Survey of 386 surgeons, anesthesiologists, pharmacists, NP/Pas of potential use of an approved product with the attributes |
for which we are developing HTX-011 | |
HTX-011 is an investigational new drug and not approved by the FDA
Highly Focused Launch Approach: 3 Primary Hospital Targets Using $570M in Branded Pain Drugs
340B % | Target | Branded Utilization | |||||||
Hospitals | Procedures | ||||||||
Hospital Targets | |||||||||
1,305 | 54% | 8.3M | 66% | $573.9M | 76% | ||||
Target 1 | 486 | 3.2M | $259.2M | ||||||
340B + Branded | 100% | 38% | 45% | ||||||
Target 2 | 450 | 0% | 2.4M | 29% | $250.1M | 44% | |||
Non-340B + Branded | |||||||||
Target 3 | 369 | 50% | 2.7M | 33% | $64.6M | 11% | |||
Large-Procedure Volume | |||||||||
ASCs | Target | Brand Utilization | |||||||
Procedures | |||||||||
ASCs Targets | 559 | 615K | 47% | $16.9M | 24% | ||||
24 Source: Symphony Drug Market - 2017-2019 / LexisNexis Procedure Data August 2019 YTD and DRG Claims Data 2018
HTX-011 is an investigational new drug and not approved by the FDA
Profiled and Prioritized Fastest Moving Launch Accounts
$875M | $353M | $591M |
Total Hospital & ASC | Green/Yellow | Targeted Hospital & ASC |
Branded Annual WAC* | Branded Annual WAC* | Branded WAC* |
0-3 Months
When will the account order post commercial availability of HTX-011
4-8 Months
When will the account order post commercial availability of HTX-011
Target | Branded | |||
# | 340B % | Procedures | Utilization | |
Hospitals | 722 | 49% | 4.6M | $337M |
ASC | 445 | 466K | $16M |
Source: Symphony Drug Market - 2017-2019 / LexisNexis Procedure Data August 2019 YTD
25 * Excludes ON-Q
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 Ease of Use and Implementation
- Needle-freeapplication
- Eliminates the need for up to 120 injections (as in total knee arthroplasty)1 and the time needed for aspiration and application
- Avoids risks of inadvertent venous punctures and eliminates accidental needle sticks with local anesthetics2
- No specialized training or certification required to administer2
- 2 SKUs for different surgery requirements
- Reducing cost per procedure
- Minimizing waste
- Room temperature storage
- Kits fit standard OR medication carts (eg. Pyxis™) and include all components
400 mg bupivacaine | 200 mg bupivacaine |
12 mg meloxicam | 6 mg meloxicam |
14-mL | 7-mL |
SKU: stock keeping unit. aKit components include single-dose glass vial, Luer lock syringe(s), vented vial spike, Luer lock applicator(s), and tip cap(s).
Source: 1. Mont MA, Beaver WB, Dysart SH, et al. J Arthroplasty. 2018;33(1):90-96.2. ZYNRELEF [instructions for use]. San Diego, CA: Heron Therapeutics Inc; 2020.
26 3. ZYNRELEF [instructions for use]. San Diego, CA: Heron Therapeutics Inc; 2020.
HTX-011 is an investigational new drug and not approved by the FDA
Market Opportunity for Zynrelef in Europe is ~15.8M Procedures of Which ~80% are Priority Procedures
15.8m 81%
priority
in-scope procedures
procedures (aggressively targeted)
.0M | ||||
4.0 | ||||
2.5M | 2.4M | |||
2.5 | 2.4 | 1.9M | ||
3.3M | 1.9 | 1.6M | ||
1.6 | ||||
(82%) | 2.0M | 1.9M | 1.5M | |
1.3M | ||||
(81%) | (79%) | |||
(80%) | ||||
(80%) | ||||
Key: 58 in-scope procedures
28 priority procedures (aggressively targeted)
33.4m.4
2.7M
(80%)
EU112
Notes: (1) In-scope procedures are those covered by current SmPC; (2) EU11 markets include Netherlands, Belgium, Luxembourg, Denmark, Sweden, Finland, Norway, Switzerland, Austria, Portugal, Ireland; (3) Based on 2018 procedure
volumes data; Sources: National IQVIA data (2018); Regional hospital episodes data from public national statistics databases (2018); ZYNRELEF is authorized in the European Union for the treatment of somatic postoperative pain from small-
27 to medium-sized surgical wounds in adults
Resource Savings and Better Pain Management are Key Value
Messages in EU5, as is Opioid Reduction, Particularly in the UK
EU5
1
2
3
Potential alleviation of staff and bed constraints is a key value driver for Zynrelef
Extended duration is a key strength to ~80% of HCPs and payers across the EU5. Demonstrating earlier discharge, reduction in length of stay and cost of care is highly compelling for payers1
ZYNRELEF's ability to better manage severe pain versus the standard of care is a highly positive value message for HCPs
Adequate treatment options for severe pain is seen as a key unmet need in Europe and for ~70% of physicians this is a key strength of ZYNRELEF
Messaging around reduction in opioid use resonates highly in the UK, where there is an opioid crisis, and is an issue of growing importance in Europe
In the UK, the majority of physicians feel there already is an opioid crisis and ~70% of HCPs and ~90% of payers see opioid-free as a strength of ZYNRELEF
In the wider EU5, risks of opioids are perceived to be lower due to strict controls and regulations, however, there is a growing recognition due to rapidly increasing opioid consumption
Notes: 1) Aside from length of stay and cost of care, resource utilization savings can also be achieved through reducing re-admissions, less staff time and effort required to manage
28 postoperative pain (e.g. reducing the need to adjust the titration of IV opioids every few hours, pressure on limited staff to manage pain for the entire recovery ward) and lowering total drug spend
There is an Opportunity in Europe to Demonstrate Significant Reductions in Hospital Length of Stay across Multiple Procedures Example: Hernia Repair (HOPE Data)
Zynrelef plus OTC analgesics resulted in patient discharged 2 to 3 hours after surgery with 95%
Average length of stay for hernia repair2
of patients opioid-free through Day 151
Opioid-free through day 15 recovery | 95% |
Received no opioids before discharge | 95% |
Received no discharge opioid | 91% |
prescription | |
Took no opioids post discharge | 97% |
Called site for postoperative pain (and | 0% |
had no opioid discharge prescription) | |
2.2 | ||
2.4 | ||
2.5 | ||
1.1 | ||
1.2 | ||
1.8 | ||
Key | Length of stay in # | |
of days | ||
There is an opportunity to demonstrate significant cost savings through stay reductions for hernia repair and other procedures
Zynrelef may allow a greater number of procedures to be preformed in the outpatient setting
Notes: 1) Open inguinal hernia repair patients were treated with ZYNRELEF and a scheduled non-opioid oral over-the-counter (OTC) analgesic regimen (N = 93). 2) Two cohorts of patients were studied under Alternating or Concurrent
multimodal analgesia (MMA) regimens. Alternating regimen (N=46): OTC regimen of ibuprofen 600 mg every 6 hours (q6h) alternated 3 hours later with acetaminophen 1 g q6h. Concurrent regimen (N=47): OTC regimen of ibuprofen 600 mg and acetaminophen 1 g, taken together q6h. 3) Opioids were only prescribed at discharge for patients who rated their pain at ≥6 (NRS) or received opioid rescue medication prior to discharge. 4) Average length of stay (LOS) for 58 surgical
29 procedures Heron is initially targeted based ZYNRELEF's ability to address unmet needs and commercial considerations. In a survey of 304 physicians in EU5, 58 procedures were defined by wound size (small, medium and large), and classified by length of stay. The mean LOS was determined by market, specialty, and procedure.
Sources: 1) Data on file. Study ZYNRELEF-304. San Diego, CA: Heron Therapeutics Inc; 2019. 2) Heron Therapeutics EU Physician Survey (2020).
HTX-011 Clinical Development
Postoperative Pain
30
EPOCH 1
(Bunionectomy)
and Follow-on
Study
Not actual health care provider. | 31 |
EPOCH 1 Follow-on:HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours
10
9
8
7
Pain Intensity 6
Score* 5
(Mean ± SE)
4
3
2
1
0
32
EPOCH 1 & EPOCH 1 Follow-OnCross-Study Comparison
EPOCH 1: Saline Placebo (N=100)
Severe pain ≥ 7
EPOCH 1: Bupivacaine HCI 50 mg (N=155)
EPOCH 1: HTX-011 60 mg (N=157)
Mild pain (0-4)
EPOCH 1 Follow-on:HTX-011 ≤ 60 mg + OTC (N=31)
0 | 12 | 24 | 36 | 48 | 60 | 72 |
Time (hour)
Using Numeric Rating Scale (NRS) with window worst observation carried forward (wWOCF)
OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h
EPOCH 1: Reg Anesth Pain Med. 2019;44:700-706. EPOCH 1 Follow-on accepted for publication in J. Am Podiatric Med Assoc (JAPMA)
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 Significantly Reduced the Proportion of Patients Experiencing Severe Pain and Increased Proportion of Opioid-Free Patients
EPOCH 1 (Bunionectomy) | EPOCH 1 Follow-on |
100% | ||||||
% | 80% | |||||
Opioid-free60% | p < 0.0001 | |||||
Through | ||||||
72 Hours | 40% | p = 0.0001 | ||||
20% | 28.7% | |||||
2.0% | 11.0% | |||||
0% | ||||||
Saline | Bupivacaine | HTX-011 | ||||
Placebo | HCI 50 mg | 60 mg | ||||
N=100 | N=155 | N=157 |
77.4% | 100% of subjects opioid | ||
free through 72 hours | |||
remained opioid free | |||
through Day 28 | |||
Percent of Patients With Severe | |||
Pain at Any Time Through 72 hours | |||
HTX-011 + OTC | 29% | ||
HTX-011 | 53.5% | ||
Saline Placebo | 83.0% | ||
p<0.0001 | |||
Bupivacaine | 75.5% | ||
p<0.0001 | |||
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
33
HTX-011 is an investigational new drug and not approved by the FDA
EPOCH 2
(Herniorrhaphy)
and Follow-on
Study
Not actual health care provider. | 34 |
EPOCH 2 Follow-on:HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours
10
9
8
7
Mean 6
Pain Intensity 5
Score
(SE) 4
3
2
1
0
0
EPOCH 2 & EPOCH 2 Follow-OnCross-Study Comparison
Severe pain (≥ 7)
EPOCH 2: Saline Placebo (N=82)
EPOCH 2: Bupivacaine HCI 75 mg (N=172)
EPOCH 2: HTX-011 300 mg (N=164)
EPOCH 2 Follow-on:HTX-011 300 mg + OTC (N=33)
Mild pain (0-4) | |||||||||||
12 | 24 | 36 | 48 | 60 | 72 |
Time (hour)
OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h
35 EPOCH 2: published online Hernia. doi: 10.1007/s10029-019-02023-6. EPOCH 2-Follow-on: Surgery. doi: 10.1016/j.surg.2020.06.036
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 Significantly Reduced the Proportion of Patients Experiencing Severe Pain and Increased Proportion of Opioid-Free Patients
100%
80%
-
60%
Opioid-free
Through
72 Hours 40%
20%
0%
EPOCH 2 (Herniorrhaphy)
p < 0.0001
p = 0.0486
51.2%
40.1%
22.0%
Saline | Bupivacaine | HTX-011 |
Placebo | HCI 75 mg | 300 mg |
EPOCH 2 Follow-on
90.9% | 93% of subjects opioid | ||
free through 72 hours | |||
remained opioid free | |||
through Day 28 | |||
Percent of Patients With Severe | |||
Pain at Any Time Through 72 hours | |||
HTX-011 + OTC | 15.2% | ||
HTX-011 | 48.8% | ||
Saline Placebo | 81.7% | ||
p<0.0001 | |||
Bupivacaine | 60.5% | ||
p=0.0372 | |||
HTX-011
300 mg + OTC
N=82 | N=172 | N=164 | N=33 |
OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with acetaminophen 1000 mg q6h
36
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
Complete Opioid-Free Recovery
Received an Opioid Predischarge
Received an Opioid Prescription
Took an Opioid Post Discharge
Call Backs if Discharged Without
an Opioid Prescription
Satisfied, Very Satisfied, Extremely
Satisfied With Medication
95%
5%
9% (10 pills)
3% (all patients had received predischarge opioid)
0%
93%
N=93 in initial pilot program
Presented at the American Society of Health-System Pharmacists (ASHP) Midyear 2019 Congress, December 8-12, 2019, Las Vegas, NV.
38
HTX-011 is an investigational new drug and not approved by the FDA
Study 306
Total Knee
Arthroplasty
(TKA)
Not actual health care provider. | 39 |
Study 306 TKA: HTX-011 + Generic Non-Opioid Analgesics* Kept Pain in the MiId Range Through 72 Hours With Low Opioid Consumption and Up to 26% Opioid-Free
Severe Pain (≥ 7)
Mild Pain (0-4)
- Cohort 1 patients received oral acetaminophen 1000 mg every 8 hours (maximum 3000 mg/d) and oral celecoxib 200 mg every 12 hours for 72 hours. Mont doi: 10.1016/j.arth.2017.07.024
- Cohort 4 patients received over the counter analgesic regimen of acetaminophen 1000 mg q8h and ibuprofen 600 mg q6h for 72 hours
40 LOCF for missing pain data
HTX-011 is an investigational new drug and not approved by the FDA
Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study (Dysart 2019)
Cross-Study Comparison of 0 - 24 | Study 306 | PILLAR Study | |||
Hour Results in TKA Using Pillar- | |||||
HTX-011 + | HTX-011 + | Exparel + | Bupivacaine1 | ||
Based MMA and the Same Analysis1 | |||||
APAP + celecoxib | APAP + ibuprofen | Bupivacaine1 | |||
(N = 69) | |||||
(Cohort 1, n=51) | (Cohort 4, n=19) | (N = 70) | |||
AUC0-24 VAS Pain 2 | 59.8 | 62.1 | 98.5 | 121.6 | |
Opioid-Free | 21.6% | 47.4% | 17.1% | 1.4% | |
Mean Opioid Consumption MME (SD) | 10.6 (9.25) | 5.9 (7.95) | 45.5 (35.01) | 56.8 (38.26) | |
Log-transformed Geometric Mean | 0.54 | 0.01 | 3.5 | 38.5 | |
Opioid Consumption MME | |||||
Discharge Ready in 24 hours Based | |||||
68.6% | 73.7% | Not shown | Not shown | ||
MPADSS > 9 | |||||
1. | https://doi.org/10.1016/j.arth.2018.12.026. | ||||
2. 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
41
HTX-011 is an investigational new drug and not approved by the FDA
Cross-Study Comparison of 48 Hour Results From Study 306 and Exparel Pillar Study (Mont 2017)
Comparison of 48 Hr Results in TKA | Study 306 | PILLAR Study | ||
Using Pillar-Based MMA and the | HTX-011 + | HTX-011 + | Exparel + | Bupivacaine1 |
Same Analysis1 | APAP + celecoxib | APAP + ibuprofen | Bupivacine1 | |
(N = 69) | ||||
(Cohort 1, n=51) | (Cohort 4, n=19) | (N = 70) | ||
Mean AUC12-48 VAS Pain | 145.4 | 125.7 | 180.8 | 209.3 |
Opioid-Free | 11.8% | 26.3% | 10% | 0% |
Mean Opioid Consumption (MME ) | 19.4 ( Median=15.8) | 13.0 (Median = 5.0) | Not Shown | Not Shown |
Log-transformed Geometric Mean | ||||
3.0 | 0.3 | 18.7 | 84.9 | |
Opioid Consumption MME | ||||
< 20 MME @ 48 hr | 58.8% | 73.7% | 18.6% | 4.4% |
> 20 and < 220 MME @ 48hr | 41.2% | 26.3% | 78.6% | 87% |
> 220 MME @ 48 hr | 0 | 0 | 2.9% | 8.7% |
DID NOT Receive a Discharge | ||||
76.5% | 68.4% | Not Shown | Not Shown | |
Prescription for Opioids | ||||
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
42
HTX-011 is an investigational new drug and not approved by the FDA
HTX-011 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)
43
HTX-011 is an investigational new drug and not approved by the FDA
HTX-034 Development
Next Generation Product for Postoperative Pain
44
In Addition to Changes in pH, Inflammation From Surgery Modifies Pain Pathways and Can Produce Hyperalgesia
Local tissue damage activates a variety of cells, | Peripheral mediators of inflammation |
which release inflammatory mediators1,2 | |
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 aprepitant, an additional agent targeting the inflammatory process that further potentiates the activity of bupivacaine
Aprepitant
Macrophage | Mast cell | Tissue damage |
Platelets | ||
Immune cells |
Inflammation
Mediators
Substance P
CGRP
Nociceptor Receptors
References: 1. Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140(6):441-451.2. | |
45 | Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009;139(2): 267-284. |
HTX-034 is an investigational new drug and not approved by the FDA
Aprepitant Has Been Shown to Significantly Reduce Postoperative Pain Medications and Lower Pain After Laparoscopic Gynecological Procedures*
VAS Pain Scale
12 | |
10 | |
p>0.05 | |
Scale | 8 |
4 | |
VASPain | |
6 |
2
0
PlaceboAprepitant
Acute Pain (0-2 hrs) | Delayed Pain (2-24 hrs) | ||
Pain Medications (mg)
Postoperative Pain Medications
30
25
20
15 | p<0.05 |
10
5
0
PlaceboAprepitant
Diclofenac | Pentazocine | |
46 *Published results from Kakuta N, et al. J Med Invest 58:246-251;2011 (n=64)
HTX-034 Produces Complete Elimination of Pain Through
7 Days in Pig Postoperative Pain Model
Withdrawal Force (g)
47
Saline Placebo | Liposomal Bupivacaine | HTX-011 | HTX-034 (Cohort 1) | HTX-034 (Cohort 2) | ||||
60.0
50.0
40.0
30.0
20.0
10.0
0.0
1h | 3h | 5h | |||||
Day | Day 1 | Day | Day | Day | Day | Day | Day |
-1 | 2 | 3 | 4 | 5 | 6 | 7 |
Data from multiple animal experiments using a validated postoperative pain model in pigs from Castle et al, 2013 EPJ
HTX-011 & HTX-034 are investigational new drugs and not approved by the FDA
HTX-034 21.7 mg Produced Greater Pain Reduction and Lower Opioid Use than HTX-011 30 mg in Study 208 or HTX-011 60 mg in Study 301
- These cross-study comparisons confirm that addition of aprepitant in HTX-034 enhanced the activity of bupivacaine in the formulation
- 45.5% of patients receiving HTX-034 21.7 mg opioid-free through Day 15 without scheduled MMA
- Phase 2 will begin 1Q2021
HTX-034 21.7 mg vs HTX-011 30 mg | HTX-034 21.7 mg vs Matched Bupivacaine and HTX-011 60 | ||||
mg | |||||
Opioid Use | HTX-034HTX-011 | HTX-011 | |||
Through 72 hrs | 21.7 mg | 30 mg | 60 mg | ||
Median MME | 2.5 mg | 17 mg | 12.5 mg | ||
Opioid-Free | 45.5% | 16.7% | 28.7% | ||
48
HTX-034 Phase 1b Safety Summary
HTX-034 was well tolerated with no:
- Clinically meaningful differences in adverse events
- Serious adverse events
- Premature discontinuations due to adverse events
- Local anesthetic systemic toxicity (LAST)
- Wound healing related adverse events
49
HTX-019 for Postoperative Nausea and Vomiting (PONV)
50
HTX-019 is an investigational new drug for PONV and not approved by the FDA
PONV
- PONV is a large market ~20x the size of CINV
- HTX-019has significant potential advantages over oral aprepitant and fosaprepitant
- IND active, BE to oral aprepitant demonstrated and 505(b)(2) NDA for PONV prevention planned for Q4 2021
- Several hundred million dollar a year potential market opportunity, taking the majority of the oral aprepitant market and use in high risk procedures
51
HTX-019 is an investigational new drug for PONV and not approved by the FDA
Aprepitant Efficacy - Large Differential in Vomiting Episodes
Compared to Ondansetron*
- of patients with No Vomiting
Aprepitant 40 mg p.o. Aprepitant1 125 mg p.o. Ondansetron 4 mg i.v.
Hours post surgery
Figure 5. Kaplan-Meier curves for the time to first vomiting during the 48 h following surgery. The time to first vomiting was delayed by aprepitant; P 0.001 based on the log-rank test.
Aprepitant delayed the time to first vomiting episode compared with ondansetron.
52 *Published results from Gan TJ, et al. Ambul Anesth. 2007; 1082-89.
2020 Cochrane Meta-Analysis Concluded That Aprepitant is the Most Effective Drug for PONV*
Approximately 100 fewer patients vomiting per 1000
53 *Weibel S, Rücker G, Eberhart LHJ, Pace NL, Hartl HM, Jordan OL, et al. Cochrane Database of Systematic Reviews. 2020
PONV Market is >20X the size of the CINV Market
PONV ~53M Treatments vs. ~2.5M CINV Treatments
Patient Population & Market Size
DiagnosticsPatients by PONV RiskSurgeries
~26M | 24% | ~39M | |
US Diagnostic | 46% | High | US Surgical |
Risk | |||
Low | |||
Procedures at Risk of | Procedures at Risk of | ||
Risk | 29% | ||
PONV in 2020 | PONV in 2020 | ||
Mod
Risk
- Approximately 65M diagnostic and surgical procedures are at risk of resulting in PONV in the US
- More than half of these patients are at moderate to high risk of PONV
Prophylaxis PatientsPONV Rescue Patients
~13M
~35M | PONV Rescue Patients |
in 2020 | |
PONV Prophylaxis Patients in 2020 | ~5M |
2nd Line Rescue in 2020 |
54 Source: PONV quantitative survey DRG June 2020
Target ~ 14M Surgical Procedures Where
PONV is High Clinical Concern
~39M Surgical Procedures that Could Result in PONV
Key Surgical Types where Postoperative Emesis could be Clinically Concerning
Abdominal (GI and OB)
As vomiting directly involves the gastrointestinal tract, emesis can directly injure surgical sites that involve this organ system
CV / CT
Retching and vomiting can lead to transient increases in blood pressure which can result in damage/disruption of arterial surgical sites
Cranial
Intracranial pressure increases during emesis, cranial surgeries, such as craniotomy, are at elevated risk of poor outcomes due to PONV
~14M
"High Clinical Concern" Procedures in 2020
(36% of all Surgical Procedures)
~5M Clinically Concerning Cases of PONV
(35% of patients undergoing these procedures may develop PONV despite prophylaxis)
HCPs are more likely to take an aggressive approach managing PONV in cases where
postoperative emesis could have a negative impact on the patient's clinical outcomes
55 Source: PONV quantitative survey DRG June 2020
Oral Aprepitant is Already Rapidly Growing
with No Promotion, Product Limitations and High Acquisition Cost
Oral Aprepitant - 40MG | 613K |
471K
362K
300K 302K
220K
135K
2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
2021-2023 Projected Totals |
- Oral Aprepitant volume is growing rapidly at premium price despite no promotion
- Q2'20 WAC ~ $88/capsule
- Acquisition cost: $43 - $64 per capsule1
- ~ 1,100 current ordering accounts2
- HTX-019advantages vs. Oral Aprepitant
- Flexible 30-second IVP vs. oral administration
- Onset of action - 5 minutes vs. 1 to 3 hours
- Heron product promotion efforts
- Strategic fit with HTX-011
- Same commercial organization
- Same Hospital & ASC targets
- Same surgeon, anesthesiology & pharmacy targets
- More convenient formulations of NK-1 class are needed based on existing PONV guidelines
56 Source: 1 Banner Health, 2 IQVIA DDD Non-Retail data Q4'20
HTX-019 is an investigational new drug for PONV and not approved by the FDA
HTX-019 for PONV is Ideal Strategic Fit for Heron
- Large market ~ 14M target surgical procedures with significant unmet need for more convenient formulations of NK-1 class drugs
- Potential Significant Advantages of HTX-019
- 30-secondIV Push injection with immediate onset of action
- Aprepitant is the most effective therapeutic agent for emesis
- 505(b)(2) regulatory pathway for existing asset
- Existing contract manufacturers
- Synergies with HTX-011 commercial organization
- Same target accounts and target audiences
- Capacity & access advantages of adding a 2nd product to promote
- Minimal incremental investment will improve ROI
57
HTX-019 is an investigational new drug for PONV and not approved by the FDA
CINV Commercial Products
58
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 - Generic fosaprepitant entered the market in September 2019 and let to reduced sales of CINVANTI in 2020; however, we believe the impact of the arbitrage is substantially over, with customers returning to CINVANTI beginning in 1Q2021
SUSTOL®
- The Aloxi arbitrage is over and Heron has implemented an innovative strategy to refresh the value of SUSTOL
- The ASP for SUSTOL was reset January 2021, which should allow for increased sales
CINV Franchise
- Preliminary 2020 net product sales for CINV franchise of ~$88.3M compared to guidance of $85M, which was increased from $70M - $80M
- 2021 net sales guidance for CINV franchise: $130M - $145M
59
Heron's CINV Portfolio Has Generated Over $340M Since Inception,
CINV Franchise Sales Will Return to Growth in 2021 & Beyond
- Launch of generic Emend IV in September 2019 resulted in declining CINVANTI sales
- Clinic-basedpractices are much faster to take advantage of the arbitrage, but are expected to return to CINVANTI post-arbitrage in early 2021
- SUSTOL sales continue to be low due to the Refresh Program and should rebound in 1Q2021
CINV portfolio net sales by quarter
$42.6M
$36.7M
$34.8M | |||||||||||||||||||||||
$31.6M | |||||||||||||||||||||||
CINVANTI | $28.8M | ||||||||||||||||||||||
SUSTOL | $25.4M | ||||||||||||||||||||||
$36.4M | $22.7M | ||||||||||||||||||||||
$19.8M | $33.2M | $20.0M | $20.3M | ||||||||||||||||||||
$17.3M | |||||||||||||||||||||||
$23.4M | $28.0M | $34.4M | |||||||||||||||||||||
$11.6M | $11.2M | $16.4M | $25.2M | $22.5M | |||||||||||||||||||
$19.8M | $20.0M | ||||||||||||||||||||||
$5.2M | |||||||||||||||||||||||
$6.4M | $6.1M | $3.4M | $5.4M | $3.6M | $3.5M | $6.26M | |||||||||||||||||
$0.4M | $0.2M | $0.1M | $0.3M | ||||||||||||||||||||
$0.1M | |||||||||||||||||||||||
60 | Q1 2018 | Q2 2018 | Q3 2018 | Q4 2018 | Q1 2019 | Q2 2019 | Q3 2019 | Q4 2019 | Q1 2020 | Q2 2020 | Q3 2020 | Q4 2020 | |||||||||||
Note: SUSTOL sales from Q4 2016- Q4 2017 of $32.05M not shown in graph
CINVANTI - Hospital Share/Units Were Down in 1Q20 Through 3Q20 Due to the Emend IV Generic Arbitrage, but Began to Rebound in 4Q
130K | Hospital Share | Hospital Units | 120K | ||||||||||
120K | 113K | ||||||||||||
+5% | |||||||||||||
110K | 103K | ||||||||||||
99K | |||||||||||||
95K | |||||||||||||
100K | 91K | ||||||||||||
88K | |||||||||||||
90K | |||||||||||||
Units | 80K | ||||||||||||
70K | 67K | 43% | 40% | ||||||||||
37% | |||||||||||||
Pack | 60K | 53K | 35% | 34% | |||||||||
33% | |||||||||||||
32% | |||||||||||||
50K | |||||||||||||
40K | 26% | ||||||||||||
28K | |||||||||||||
30K | 21% | ||||||||||||
20K | 9K | 12% | |||||||||||
10K | |||||||||||||
0K | 4% | ||||||||||||
0K | |||||||||||||
2018-Q1 | 2018-Q2 | 2018-Q3 | 2018-Q4 | 2019-Q1 | 2019-Q2 | 2019-Q3 | 2019-Q4 | 2020-Q1 | 2020-Q2 | 2020-Q3 | 2020-Q4 | ||
61 Source:867 1.5.21, : IMS DDD Q4'20 though 12.25.20 with final week projected
CINVANTI - Clinic Share/Units Declined in 1Q20 Through 3Q20 Due to the Emend IV Generic Arbitrage, but Began to Rebound in 4Q
100K | Clinic | Share | Clinic Units | 95K | ||||||||||
95K | 90K | |||||||||||||
90K | 86K | |||||||||||||
85K | 77K | |||||||||||||
80K | ||||||||||||||
75K | 71K | |||||||||||||
70K | ||||||||||||||
65K | 57K | |||||||||||||
Units | 60K | 52K | +9% | |||||||||||
55K | ||||||||||||||
50K | 44K | |||||||||||||
Pack | 42K | |||||||||||||
45K | 40K | |||||||||||||
39K | ||||||||||||||
40K | ||||||||||||||
35K | 52% | 52% | 54% | |||||||||||
30K | 22K | 45% | ||||||||||||
25K | 37% | 43% | ||||||||||||
20K | 30% | |||||||||||||
15K | 26% | 24% | 23% | 24% | ||||||||||
10K | 16% | |||||||||||||
5K | ||||||||||||||
0K | 2018-Q1 | 2018-Q2 | 2018-Q3 | 2018-Q4 | 2019-Q1 | 2019-Q2 | 2019-Q3 | 2019-Q4 | 2020-Q1 | 2020-Q2 | 2020-Q3 | 2020-Q4 | ||
62 Source:867 1.5.21, IMS DDD Q4'20 though 12.25.20 with final week projected
The NK1 Market Has Grown 43% Since the Launch of CINVANTI
+43% | 1.9M | ||||||||
1.8M | 0.1M | ||||||||
0.1M | |||||||||
1.5M | AKYNZEO VIAL | ||||||||
0.0M | 0.6M | CINVANTI | |||||||
1.3M | 0.3M | 0.7M | EMEND | ||||||
FOSAPREPITANT
0.4M
1.3M
0.9M
0.9M
0.1M | |||
2017 | 2018 | 2019 | 2020 |
63 Source: IMS DDD Q4'20 though 12.25.20 with final week projected
Financial Summary
Heron ended 2020 with cash, cash equivalents and short-term investments of ~$208.5 million.
SummaryStatement of Operations and Net Cash Used in Operations | Three Months Ended | Nine Months Ended | ||
(In thousands, except per share amounts) | September 30, 2020 | September 30, 2020 | ||
Net product sales | $ | 19,965 | $ | 68,033 |
Operating expenses1 | 78,349 | 234,900 | ||
Other income, net | 156 | 1,870 | ||
Net loss1 | $ | (58,228) | $ (164,997) | |
Net loss per share2 | $ | (0.64) | $ | (1.82) |
Net cash used in operations | $ | (42,054) | $ (132,266) | |
Condensed Balance Sheet Data | September 30, 2020 | |||
(In thousands) | ||||
Cash, cash equivalents and short-term investments | $ | 258,146 | ||
Accounts receivable, net | $ | 33,654 | ||
Total assets | $ | 390,023 | ||
Total stockholders' equity | $ | 277,147 | ||
Common shares outstanding as of September 30, 2020 totaled 90.9 million.
64 | 1 | Includes $11.1 million and $34.2 million of non-cash,stock-based compensation expense for the three and nine months ended September 30, 2020, respectively. |
2 | Based on 90.8 million and 90.7 million weighted-average common shares outstanding for the three and nine months ended September 30, 2020, respectively. |
Key Catalysts in Pain Management & CINV Franchises
HTX-011 & HTX-034 for | CINVANTI ® and | HTX-019 for PONV | ||
Postoperative Pain | SUSTOL® for CINV | |||
• CRL received 26 June 2020 | • 2020 net product sales of • | Bioequivalence of HTX- | ||
• | NDA resubmitted; PDUFA | ~$88.3M compared to | 019 32 mg to oral | |
goal date of 05/12/2021 | guidance of $85M for | aprepitant 40 mg | ||
• | EU Centralised Procedure | CINV franchise (raised | achieved in Phase 1 | |
• | European Commission | from $70M - $80M) | study | |
Authorization received | • | 5050(b)(2) NDA for | ||
• | UK Authorization received | PONV planned for | ||
• | Canadian NDS | 4Q2021 |
- Responses to questions in process
• Promising HTX-034 Phase 1b | • 2021 net sales guidance | • Potential approval in |
bunionectomy results | for CINV franchise: | |
2H2022 | ||
• Phase 2 will start 1Q | $130M - $145M | |
65
HTX-011,HTX-034 and HTX-019 are investigational new drugs and not approved by the FDA
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Heron Therapeutics Inc. published this content on 11 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 January 2021 19:41:07 UTC.