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) June 2, 2014
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.) |
| 123 Saginaw Drive Redwood City CA |
94063 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (650) 366-2626
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)) |
| ITEM 8.01 | Other Events. |
On June 2, 2014, Heron Therapeutics, Inc. (the “Company”) issued a press release regarding the Company’s planned resubmission of its NDA for SUSTOL™. A copy of the press release is attached hereto as Exhibit 99.1.
The Company will deliver a corporate presentation at the Jefferies Healthcare Conference on June 2, 2014. The slides from the presentation are attached hereto as Exhibit 99.2. The attached materials have also been posted on the Company’s website at www.herontx.com. The Company does not undertake to update this presentation.
| ITEM 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated June 2, 2014 | |
| 99.2 | Corporate Presentation, dated June 2, 2014 | |
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SIGNATURE
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: June 2, 2014 | /s/ Brian G. Drazba | |||||
| Brian G. Drazba | ||||||
| Vice President, Finance and Chief Financial Officer | ||||||
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Exhibit 99.1
Heron Therapeutics Provides Update on SUSTOL™ Program
- SUSTOL™ Phase 3 study in delayed-HEC patients progressing rapidly – over 100 site locations opened in first two months
- Based on faster than expected start-up, Heron now plans to include delayed-HEC results in NDA resubmission planned for fourth quarter
REDWOOD CITY, Calif. – June 2, 2014 – Heron Therapeutics, Inc. (NASDAQ: HRTX), a specialty pharmaceutical company, announced today that it has achieved a rapid start-up of its ongoing Phase 3 clinical trial of SUSTOL™ (granisetron) for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
As a consequence of the rapid start-up, results of the delayed-HEC study are anticipated earlier than previously projected and the Company now plans to include these results in its resubmission of the new drug application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA). To accommodate the inclusion of the delayed-HEC study, Heron plans to resubmit the NDA in the fourth quarter of 2014 versus the Company’s previous projection of a mid-year 2014 resubmission. Subject to approval by FDA, if the study is successful, it should enable the inclusion of a delayed-HEC indication in the SUSTOL label at the time of launch of SUSTOL rather than approximately a year following launch, as previously expected.
“I’m very pleased with the excellent start to the delayed-HEC study,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “The planned inclusion in our NDA resubmission of data regarding the safety and efficacy of SUSTOL in the delayed-HEC setting gives us the potential to launch SUSTOL with a label that is significantly differentiated from currently available therapies. Most importantly, this could enable us to immediately address a significant unmet medical need, as there is currently no 5-HT3 receptor antagonist approved for the treatment of delayed-onset CINV in patients receiving HEC regimens.”
Dr. Quart continued, “While we have successfully completed the Human Factors Validation study and all other requirements for resubmitting the SUSTOL NDA, we believe postponing the resubmission to include the delayed-HEC results will be well worth the long-term benefit of launching SUSTOL with the broadest label.”
About SUSTOL™
Heron’s lead product candidate, SUSTOL™ (granisetron), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC). SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company’s proprietary Biochronomer™ polymer-based drug delivery platform, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About Heron’s Post-Surgical Pain Program
Heron is utilizing its proprietary Biochronomer™ polymer-based drug delivery platform to develop drugs designed to extend the duration of action of known active ingredients to address important unmet medical needs. The Company has initiated full development of an established local anesthetic for the treatment of post-surgical pain formulated with its Biochronomer extended release technology. In animal models of post-surgical pain, the Company’s drug candidates demonstrated statistically significant pain relief for three days, representing the potential to significantly reduce the need for opiates post-surgery and the length of post-surgical hospital stays. Heron’s lead product candidate in this program, HTX-011, is a unique combination of local analgesic agent bupivacaine and the anti-inflammatory drug meloxicam utilizing its Biochronomer extended release technology. Heron expects to move this program into human clinical studies in the second half of 2014.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks.
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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. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the potential approval of SUSTOL™ and the potential timing for such approval, if approved at all; risks relating to progress in research and development of HTX-011, including the timing of planned toxicology and clinical studies; risks related to other programs; risks related to the launch and acceptance of new products and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.
Contacts
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
jcapuzelo@herontx.com
and
Corporate Contact:
Heron Therapeutics, Inc.
Stephen R. Davis, 650-366-2626
Executive Vice President and Chief Operating Officer
###
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Exhibit 99.2
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Company Update
June 2014
Exhibit 99.2
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Legal Disclaimer
This presentation contains “forward -looking statements” as defined by the Private Securities Litigation Reform Act of 1995. These forward -looking statements involve risks and uncertainties, including uncertainties associated with timely development, approval, launch and acceptance of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Actual results may differ materially from the results expected in our forward looking statements. We caution investors that forward -looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.
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Highlights
Lead product candidate, SUSTOLTM, is a long-acting, injectable product for the prevention of chemotherapy -induced nausea and vomiting (CINV)
_ Shown to be non-inferior to market leader Aloxi® in 1,341-patient, randomized, controlled, Phase 3 study
_ On-going 1000 patient study in patients receiving highly emetogenic chemotherapy (HEC) is designed to obtain a “delayed HEC” indication
_ No 5-HT3 agent is approved for delayed HEC
SUSTOL targets a large market opportunity, with approximately 7 million doses of chemotherapy annually in US alone*
Leveraging our Biochronomer drug delivery technology and commercial expertise for other opportunities:
_ Long-acting local anesthetic-NSAID combination for post-surgical pain in development
3 *TDR August 2006 internal report
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SUSTOL CLINICAL SUMMARY
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5-Day Profile: APF530 Pharmacokinetics
Granisetron is released rapidly following injection of APF530 and continues to be released over a 5-day period, providing long-acting coverage for CINV
(ng/mL) 20 n granisetro 15 of All subjects (n= 18) n mean ± SEM concentratio 10
5 Minimum Plasma therapeutic concentration of granisetron*
0
0 24 48 72 96 120 144 168
Time after Dosing (h)
*Data from patent application 20120258164 for transdermal granisetron
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SUSTOL Pivotal Phase 3 Study Overview
Randomized, controlled, multi-center study
1,341 patients in primary efficacy population
Two doses of APF530 (5 mg and 10 mg granisetron) compared to the approved dose of Aloxi (results from 10 mg dose group presented)
Patients stratified by type of chemotherapy regimen: moderately emetogenic (MEC) or highly emetogenic (HEC)
Primary end point compared complete response between groups in both the acute (day 1) and delayed (days 2-5) phase
_ Complete response defined as no emesis and no rescue medications
_ ±15% margin used to establish non-inferiority
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Primary Efficacy Results: Complete Response
Patients Receiving Moderately Emetogenic Chemotherapy
100.0 -´ +´
(%) 90.0
75.0 76.9 ates 80.0
70.0
R
57.2 58.5
60.0
50.0 Acute
Response 40.0
APF530 10mg
30.0
Delayed
20.0
Complete 10.0
00. mg mg mgmg . 2510 . 2510 0 0
Aloxi APF530 Aloxi APF530 -15 -10 -5 0 5 10 15
Acute Delayed Difference in Complete Response APF530 -Aloxi (97.5% CI)
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Primary Efficacy Results: Complete Response
Patients Receiving Highly Emetogenic Chemotherapy
100 -´ +´
90
(%) 80.7 81.3
80
Rates 70 64.3 67.1
60 50
Response 40
30 20
Complete 10
0 mg mg mgmg 25 .10 . 2510 0 0
Aloxi APF530 Aloxi APF530 -15 -10 -5 0 5 10 15
Acute Delayed Difference in Complete Response APF530 -Aloxi (98.33% CI)
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Safety Summary
Cycle 1 Safety Results APF530 10 mg1 Aloxi 0.25 mg N % N % Drug Related Serious Adverse Events 0 0 0 0 Discontinued Due to Adverse Event 1 0.2 0 0 Frequent Adverse Events Gastrointestinal Disorders
Constipation 72 15.4 62 13.4
Diarrhea 44 9.4 39 8.4
Abdominal pain . . Nervous System Headache 47 10.0 45 9.7 Injection Site2 Placebo (NaCl)
Bruising 93 19.9 41 8.9
Erythema (redness) 51 10.9 14 3.0 Nodule (lump) 50 10.7 3 0.6
Pain 33 7.1 5 1.1
“1 Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included
“2 >90% of injection site reactions were reported as mild; one patient discontinued due to injection site reaction
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FDA-Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxiin HEC Patients
Protocol Specified HEC Population ASCO 2011 Guideline HEC Population
100 100
90 90
(%) 81 81 (%)
80 80 75
ates 67 ates 67
70 64 70
R R
56
60 60
51
50 50
Response 40 Response 40
30 30
20 20
Complete 10 Complete 10
0 0 mg mg mg mgmgmg mg mg
25 10 25 10 25 . 10 . 2510
. .
0 0 0 0
Aloxi APF530 Aloxi APF530 Aloxi APF530 Aloxi APF530
Acute Delayed Acute Delayed
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Largest Differences Between Arms is Seen With Most Difficult Chemo Regimens 1
CR Rates by Treatment
Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg
Cyclophosphamide/Doxorubicin 70.7% 65.7% Acute Moderately All other regimens 84.4% 85.0% Emetogenic Cyclophosphamide/Doxorubicin 47.4% 46.3% Delayed
All other regimens 72.9% 70.0% Cisplatin regimens 81.1% 75.5% Acute Carboplatin/Paclitaxel 85.4% 89.8% Highly All other regimens 75.4% 67.6% Emetogenic Cisplatin regimens 66.0% 60.4% Delayed Carboplatin/Paclitaxel 70.8% 71.4% All other regimens 65.2% 57.4%
1Data from post-hoc analysis. Not statistically significant.
Highlighted HEC regimens were considered HEC in both protocol specified Hesketh and 2011 ASCO Guidelines
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Response Rates With Chemotherapy Classified as HEC by Both Hesketh and 2011 ASCO*
SUSTOL is 9-11% Better Than Aloxi in the Most Emetogenic Chemotherapy
90%
78% 80% 69%
70% 66% 60% 55% 50%
40% Aloxi SUSTOL 30% 20% 10% 0%
Acute
Delayed
*Cisplatin, carmustine, dacarbazine, dactinomycin, mechlorethamine, streptozotocin
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A Delayed-HEC Indication Would Provide Clear Differentiation in an Important Segment of the CINV Market
Distribution of Aloxi Sales*
HEC regimens account for ~20% (500K) of palonosetron administrations
HEC Minimal LEC
MEC
1 IntrinsiQ data from July 2012 - June 2013
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Phase 3 “MAGIC” Study
Superiority design assuming a CR rate of 65% in the control (ondansetron) arm, a binary endpoint (CR or no CR), a 2-sided alpha = 0.05 to test 65% vs 75%; for 90% power you need 880
evaluable patients Cycle 1
Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d 1
+ fosaprepitant 150 mg IV d 1 + DEX
+ placebo SC d1
1000 patients scheduled to receive HEC* randomized
1:1 APF530 500 mg SC d 1
+ fosaprepitant 150 mg IV d 1 + DEX + placebo IV d 1
1. All subjects will receive dexamethasone 12 mg IV on day 1 and 8 mg PO BID on days 2-4
2. All subjects will be allowed to receive “rescue” medications as required at the discretion of their treating physician
*HEC agents as defined in the 2011 ASCO CINV guidelines.
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New SUSTOL Study Has a High Likelihood of Success Based on Previous Results
Study powered for a 10% difference between arms
20% difference is expected with the addition of fosaprepitant,
100 Projected
Standard of Care Phase 3 Study HEC Study Response
90
(%) with addition
80 87% of NK1 ^^
Study
Rate 70
powered
60 to show 10% difference:
50 65% vs 75%
Response 40
45% 65% 67% 75%
30 Complete 20
10 0
Ondansetron + Dex* Ondansetron + Dex APF530+Dex APF530 + Dex
+ Fosaprepitant* + Fosaprepitant**
^^Average Complete Response rate improvement when adding an NK-1 RA to a 5-HT3 RA and Dex is ~15 - 20% in the delayed HEC *Poll-Bigelli; Cancer, 97:12, 3090, 2003 **Projection of what would happen with a 20% increased response by addition of fosaprepitant to Sustol + Dex
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Study Start-up Faster Than Projected
117 site locations have drug
Enrollment is progressing well
Expect to complete this study and be able to file full report in 4Q2014 resubmission
FDA has previously agreed that a positive outcome from this study would be sufficient to obtain “delayed -HEC” indication
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Clinical Trial Site Activation Summary
117 Study Locations Have Drug
Active Awaiting SIV Awaiting IRB/CTA
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SUSTOL Has the Potential to be the Next Generation 5-HT3 Receptor Antagonist
5-HT3
RAs 1st generation 2nd generation 3rd generation ondansetron
Products palonosetron SUSTOL granisetron
Duration of Short acting Longer acting Long acting action ~ 8 hr half-life ~40 hr half-life PK profile 5-7 days
Prevention of CINV in
MEC - acute& delayed CINV MEC - acute & delayed CINV Indications emetogenic chemo including HEC - acute CINV HEC - acute & delayed CINV* high-dose cisplatin
*Obtaining delayed HEC will be based on completion of new clinical trial
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SUSTOL REGULATORY STATUS
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SUSTOL NDA Status
Submitted NDA in May 2009 under 505(b)(2) filing pathway
Received Complete Response Letter in March 2010
FDA raised major issues in multiple areas
Resubmitted NDA in September 2012
Received Complete Response Letter March 2013 raising three main issues:
CMC: correction of PAI issues and revision of one in-vitro release method
Requirement for Human Factors Validation Study with commercial product
Re-analysis of the existing Phase 3 study using theASCO 2011 guidelines for categorization of MEC and HEC
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How We Are Addressing the CRL
“ Chemistry, Manufacturing, and Controls
_ Sites with PAI issues have been eliminated from the supply chain, with work transferred to a well-established site with no PAI issues
“ Transition is complete, with secondary benefit of improvement in the COGS
_ New in-vitro release method has been developed and validated
_ Multiple validation batches of finished product have now been completed
“ Human Factors Validation Study
_ Successfully completed
“ Re-analysis of Phase 3 using new ASCO 2011 Guidelines
_ Re-analysis complete
_ Complete dataset and programs supplied to FDA and found acceptable
“ Re-submission is planned for 4Q2014 in order to include delayed -HEC study
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Obtaining Optimal Labeling Sooner Was the Reason for Changing Our Filing Strategy
Submitting the NDA with a positive Delayed -HEC Study could obtain labeling for all four quadrants of CINV >4-months faster than with an sNDA
2014 2015 2016
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Delayed -HEC Study
Original Plan
NDA sNDA for Delayed HEC
Approval for Acute and Delayed
Approval for Delayed HEC. MEC plus Acute HEC.
Revised Plan
Achieves the Delayed -HEC Study
Best Labeling
Sooner NDA Approval for All 4 Quadrants.
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SUSTOL COMMERCIAL OPPORTUNITY
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U. S. CINV Market Dynamics
Injectable Drugs for the Prevention of CINV
800,000 Number of Package Units Sold by Quarter
700,000 600,000 500,000 400,000 300,000 200,000 100,000
0
Q2’06 Q4’06 Q2’07 Q4’07 Q2’08 Q4’08 Q2’09 Q4’09 Q2’10 Q4’10 Q2’11 Q4’11 Q2’12 Q4’12 Q2’13 Q4’13
ALOXI ANZEMET KYTRIL KYTRIL Generic (GRANISETRON) ZOFRAN ZOFRAN Generic (ONDANSETRON) EMEND
* US Oncology data added starting 1/2009. Data is Package Units; Ondansetron units reflect only 2 mg/ml and 32mg/50 ml strength sizes
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HEC Regimens Represent a Significant Market Opportunity for SUSTOL
Of all HEC administrations, ~20% are given HEC regimens account for ~20% (500K) without concomitant IV 5-HT inconsistent
of palonosetron administrations with clinical guidelines
1,600,000
1,463,558 1,200,000
1,400,000
(annual) 1,000,000
1,200,000 Untreated with
188,988
IV 5HT3 1,000,000 800,000 800,000 317,915 Treated with administrations 600,000 generic IV 5HT3
600,000
497,256
451,490 palonosetron 400,000 Treated with
400,000
Aloxi 200,000 497,256 200,000 111,696
- -
HEC MEC LEC Minimal Annual HEC administrations
1 IntrinsiQ data from July 2012 _ June 2013
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POST-OPERATIVE PAIN PROGRAM
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Goals for Pain Program
Develop products that provide a clear advantage compared to available therapies
Take advantage of the FDA’s current focus on reducing the use of opiates
Main goals of therapy for our post-operative pain program
_ Significantly reduce:
pain intensity for 3-4 days post-operatively opiate use length of hospital stay hospital readmissions due to pain
Target for product
_ Easy to use for a large variety of procedures Does not require refrigeration or special handling
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Biochronomer Bupivacaine/Meloxicam
Significantly Superior to EXPAREL at 24-72 Hours
Pig Post -Operative Pain Model
SalineControl(1) Biochronomer Bupivacaine (1)
Biochronomer Ropivacaine (1) Biochronomer Bupivacaine + Meloxicam (2)
Exparel (2) 100.0
90.0
Tolerated 80.0 (60gm) 70.0 60.0 50.0
Anima
40.0
30.0 20.0
10.0
Percentage of Maximal force 0.0
0 1 3 5 HOURS 24 48 72 96 120
1. Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ
2. Study #2 compared < 1/2 expected human dose of Biochronomer bupivacaine/meloxicam formulation to the human dose of EXPAREL (40% smaller incision used with EXPAREL)
29 (n=4 pigs, except at 120 hrs for Study #2: preliminary results from 2 animals)
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A New Formulation of Bupivacaine + Meloxicam Has Been Added to Our Pain Program
In order to achieve near complete control of pain, it is necessary to target the hyperalgesia caused by inflammation during the first several days
A combination product using our Biochronomer technology was developed
Bupivacaine was selected for the combination product due to easier co-formulation characteristics; no need for refrigeration or special handling
Meloxicam was selected as the NSAID due to its high potency, good local tolerability and minimal effects of platelets
– Local tolerability of meloxicam is very good and did not differ from placebo, even when administered daily for 4 weeks (British Journal of Rheumatology 1996;35 (suppl. l): 44-50)
– The very low dose of meloxicam in our formulation is less than half of the no-effect dose for altering Thomboxane B2 formation or platelet aggregation (Journal of Clinical Pharmacology, 2002;42:881 -886)
Combination product produced significantly better pain control than the market leader EXPAREL in preclinical post-operative pain model
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POST-OPERATIVE PAIN PROGRAM COMMERCIAL OPPORTUNITY
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The Post-Operative Pain Market Represents an Attractive Opportunity for Product Development
Post-Operative “ Total procedures expected to grow from 25MM in 2012 to over 32MM by 2022 Pain Market “ Total sales are expected to grow from $3.1B in 2012 to $3.6B in 2022
Pain is a major driver of inpatient admissions and increased length of stay
High cost of
Costs of opioid addiction & opioid-related adverse eventsare significant concerns post-operative
Reimbursement will increasingly be tied to measures of quality and patient pain satisfaction ratings
MDs commonly combine analgesics to enhance efficacy and minimize AEs
Current
Local anesthetic (LA) use is common & expected to increase with the entry of long-
Treatment acting formulations
Paradigm
MDs cite EXPAREL duration of action to be only 24-48 hours
Physicians identified the top needs to be:
– Reliable, extended duration of action
Unmet Needs
– Further pain reduction vs. what they see with existing therapies
– Further reduction or elimination of opioid use
Source: Decision Resources Post-Operative Pain Physician Research
Initiative 2014 (N=30 qualitative interviews; N=184 quantitative survey)
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U.S. Post-Operative Pain Market
Treatment options have remained stable over the past decade and new therapies are expected to be dominated by reformulations of existing molecules
The total number of procedures is anticipated to increase 3% per year driven by aging population
Unmet needs include longer-acting local anesthetics, opioids with a more tolerable side-effect profile and less addictive properties, and less invasive delivery mechanisms
2012 Post-Op Pain Market (US only) 2021 Post-Op Pain Market (US only)
Antiepileptic Traditional Antiepileptic
Traditional Drugs NSAIDs; Drugs Local Emerging NSAIDs; 9% (AED); 9% (AED); anesthetics; Agents; 2%
1% Local 1% 9% anesthetics; 11% Selective Selective COX-2 Strong inhibitors; COX-2 Strong opioid 9% inhibitors; opioid analgesics; 5% analgesics; 53% 51% Simple Simple analgesics; analgesics; Dual-Acting 11% 13% Dual-Acting Opioids; Opioids; 8% 9%
2012 Total: $3.1B 2021 Total: $3.6B
Source: Decision Resources, Post-Operative Pain Pharmacor, May 2006;
33 Decision Resources, Acute Pain, December 2012
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A Wide Variety of High-Volume Procedures Require Post-Op Pain Management for up to 3Days or More
Timeframe of
Volume of % Using
Top Surgical Post-Op Pain % Using Procedure Procedures Local Specialty* Management NSAIDs Per Month Anesthetics (hours)†
Cholecystectomy (inpatient) General 10 25-72 50% 43% Arthroplasty knee (inpatient) Orthopedic 10 >72 71% 47% Hernia (inpatient) General 10 25-72 54% 48% Cesarean Section OB/GYN 10 25-72 56% 47% Arthroplasty knee (outpatient) Orthopedic 10 0-24 68% 49% Hip replacement, total and partial Orthopedic 9 >72 57% 43% Cholecystectomy (outpatient) General 9 0-24 54% 51% Treatment, fracture or dislocation of hip and femur (inpatient) Orthopedic 8 >72 43% 33% Hernia (outpatient) General 8 0-24 65% 57% Arthroplasty other than hip, knee, shoulder, or elbow Orthopedic 8 >72 60% 40% Other non-OR therapeutic procedures on musculoskeletal system Orthopedic 8 25-72 43% 42% Repair of toe Orthopedic 8 0-24 60% 41% Other therapeutic procedures on muscles and tendons Orthopedic 7 25-72 52% 48% Other fracture and dislocation procedure Orthopedic 7 >72 51% 39% Arthroplasty shoulder Orthopedic 6 >72 72% 49%
Source: Decision Resources Post-Operative Pain Physician Research Initiative 2014 (N=30 qualitative interviews; N=184 quantitative survey)
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³72 hour Duration of Action Seen as “Ideal” by Physicians , With 48 hours Minimally Acceptable
Ideal Duration of Efficacy for Long-Minimally Acceptable Duration of Acting Local Anesthetic Efficacy for Long-Acting Local Anesthetic
>5 days 2% 5 days 4% £ 24 hours 72 hours 4 days 12% 11% 9%
£ 24
48 hours hours 27% 44%
48 hours 72 hours 45% 46%
Source: Decision Resources Post-Operative Pain Physician Research
Initiative 2014 (N=30 qualitative interviews; N=184 quantitative survey)
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Local Anesthetic With Reliable 3-Day Duration of Action Would be an Important Advance
“With EXPAREL, although it is meant to last for up to 72 hours, I’m seeing more like 24-48 hours in my patients.” – Orthopedic Surgeon
“A local anesthetic with a consistent, reliable duration of action of 3 days would be extremely valuable.” – Anesthesiologist
Procedures mentioned by MDs where 3 days of post-operative pain management is critical
Orthopedic
Hip replacement
Knee replacement
Shoulder surgeries
Foot / ankle surgeries
Hand surgeries
Spinal procedures
Soft Tissue
Hernia
Appendectomy
Hysterectomy
Prostatectomy
Nephrectomy
Laparoscopic abdominal surgeries
Source: KOL interviews October 2013
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Across Procedures, Many MDs Expect the Use of Long-Acting Local Anesthetics to Increase
Use of Long-Acting Local Anesthetics in the Future, by Procedure
Arthroplasty knee (inpatient) 3% 49% 48% Hernia (inpatient) 7% 47% 46% Hip replacement, total and partial 3% 49% 48% Hernia (outpatient) 5% 41% 54%
Arthroplasty other than hip, knee,
7% 50% 43%
shoulder, or elbow
Cholecystectomy (inpatient) 6% 60% 35%
Other therapeutic procedures on
7% 60% 34%
muscles and tendons
Arthroplasty shoulder 2% 44% 53%
Repair of toe 5% 66% 28%
Other fracture and dislocation
6% 58% 37%
procedure
Treatment, fracture or dislocation of
6% 58% 36%
hip and femur (inpatient)
Other non-OR therapeutic
9% 62% 29% procedures on musculoskeletal &
Arthroplasty knee (outpatient) 5% 45% 49% Cholecystectomy (outpatient) 7% 60% 33% Cesarean Section 10% 53% 37%
0% 20% 40% 60% 80% 100%
Percentage of physicians indicating how frequently they expect to use long-acting local anesthetics in the future
Less frequently Same amount More frequently
“Minimizing opioid use by using long-acting local anesthetics is the trend. I think the long-acting local anesthetics have great promise in the future.”
– General surgeon 6
Source: Decision Resources Post-Operative Pain Physician Research Initiative 2014 (N=30 qualitative interviews; N=184 quantitative survey)
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Next Steps for Post-Operative Pain Program
Combination formulation has been selected
Starting Phase 1 enabling toxicology
Initiate Phase 1 with combination product in second half 2014
Assuming positive results from Phase 1, initiate Phase 2 program before the end of this year
Continue development of Biochronomer ropivacaine formulation focused on nerve block, where the inflammatory component of pain may not be relevant
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Heron Therapeutics pipeline offers significant opportunity for commercial value creation
Chemotherapy-induced nausea and vomiting
Large, concentrated commercial opportunity
MDs view a non-inferior SUSTOL profile as highly competitive with palonosetron
A differentiated profile, based on a successful outcome of the HEC study, would position SUSTOL as the next generation 5-HT3
_ Only 5-HT3 indicated for acute and delayed CINV in MEC and HEC regimens
_ Extended release profile provides CINV protection for full 5 days in MEC and HEC
_ Data showing sustained efficacy over multiple cycles and efficacy in palonosetron failures
_ Favorable safety with clean QT profile
HEC regimens represent a significant market opportunity
Post-operative
pain management
Large, growing market
Significant unmet needs remain
– Reduced pain
– Reduced opioid consumption and opioid-related AEs
– Reduced hospital LOS
MDs expect use of long-acting LAs to increase
EXPAREL represents meaningful advance over short-acting local anesthetics but DOA beyond 24 hours is questionable
Innovative product that delivers reliable 3-day duration of action would offer differentiated value
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Financial Summary
Summary Statement of Operations Three Months Ended (In thousands, except per share data) March 31, 2014
Revenue $ – Operating expenses 17,322 Other income (expenses) (216) Net loss $ (17,538) Net loss per share1 $(0.74)
Condensed Balance Sheet Data
March 31, 2014 (In thousands)
Cashandcash equivalents $ 57,475 Total assets $ 62,793 Total stockholders’ equity $ 55,409
1 Based on 23.7 million weighted average common shares outstanding for the period ended March 31, 2014 (1-for-20 reverse stock split in JAN2014).
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