Company Update. September 2016
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- Egbert Wilson
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1 Company Update September 2016
2 Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 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 forwardlooking statements. These risks and uncertainties include, but are not limited to, those associated with: the potential market opportunity for SUSTOL, HTX-019 and HTX-011, the expected timing and acceptance of the SUSTOL commercial launch, whether the HTX-011 Phase 2 study results are indicative of the results in future studies, the sufficiency of the Phase 2 data to allow the commencement of Phase 3 registration studies for HTX-011, the timing of the NDA filing for HTX-019, the projected sufficiency of our capital position for future periods, our ability to repay any indebtedness, the progress in the research and development of HTX-019, HTX- 011 and our other programs, including the timing of preclinical, clinical, and manufacturing activities, safety and efficacy results from our studies, 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
3 Status of Product Portfolio CINV Pain Preclinical Clinical NDA Approved SUSTOL (granisetron) extended-release injection HTX-019 Injectable aprepitant Now Approved by U.S. Food and Drug Administration IV NK 1 for CINV Prevention 505(b)(2) Pathway: BE Study completed; Phase 2 & 3 studies should not be required; NDA Submission Expected 4Q16 HTX-011 bupivacaine + meloxicam ER Local Administration Post-Op Pain in Local Administration Phase 2 Studies In Multiple Surgical Models Underway HTX-011 bupivacaine + meloxicam ER Nerve Block Post-Op Pain in Nerve Block Planned Expansion of Phase 2 Program in Nerve Block Supported by Mayo Block Results in Bunionectomy 3
4 SUSTOL Now Approved by U.S. FDA U.S. Commercial Launch Planned For Q
5 Preventing CINV Throughout Both Acute and Delayed Phases Remains a Significant Unmet Need 5 Patients identified CINV as the side effect of chemotherapy they most wanted to avoid Least acceptable More acceptable Median visual analog scale (VAS) where 0 is the least favorable and 1 is the most acceptable/favorable Sun CC et al. Support Care Cancer. 2005;13: Van Laar ES et al. Support Care Cancer. 2015;23:151-7 Percent of patients experiencing CINV % of MEC/HEC patients with breakthrough CINV despite prophylaxis Community practice observational study 70% 60% 50% 40% 30% 20% 10% 0% 51% (n=132) HEC Source: Gilmore JW et al. J Oncol. 2014;10: % (n=610) MEC Data from a prospective observational study enrolling chemotherapy-naive patients who received single-day HEC or MEC at four oncology practice networks, all using electronic medical record (EMR) systems, in Georgia, Tennessee, and Florida. CINV = emesis or clinically significant nausea on days 1-5. For HEC=5-HT3+NK-1+CS on Day 1; NK-1 on Days 2-3; CS on Days 2-4; For MEC=5-HT3+NK-1+CS on Day 1; 5-HT3, NK-1, or CS on Days 2-3
6 SUSTOL Indication SUSTOL 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. 1 Acute Delayed MEC Yes Yes HEC AC-based regimens AC-based regimens SUSTOL is the first and only extended-release 5-HT3 receptor antagonist indicated to provide 5-day CINV prevention in MEC and ACbased regimens Please see accompanying Full Prescribing Information and Important Safety Information at 2 SUSTOL is indicated for prevention of CINV due to MEC and AC combination chemotherapy. National clinical practice guidelines for antiemesis classify ACbased regimens as highly emetogenic; NCCN 2016; ASCO 2011.
7 AC-Based Regimens are Classified as Highly Emetogenic by National Clinical Practice Guidelines Highly Emetogenic Chemotherapy NCCN AC combination chemotherapy* Carmustine >250 mg/m 2 Cisplatin Cyclophosphamide >1,500 mg/m 2 *Defined as either doxorubicin or epirubicin with cyclophosphamide Dacarbazine Doxorubicin >60 mg/m 2 Epirubicin >90 mg/m 2 Ifosfamide >2 g/m 2 Mechlorethamine Streptozotocin ASCO AC combination chemotherapy* Carmustine Cisplatin Cyclophosphamide >1,500 mg/m 2 *Defined as doxorubicin, epirubicin, idarubicin, or daunorubicin with cyclophosphamide Dacarbazine Dactinomycin Mechlorethamine Streptozotocin 7 Sources: NCCN 2016; ASCO 2011
8 The Branded 5-HT3 Market (Aloxi) Consists of ~2.5 Million Units 800,000 Injectable 5-HT3 Receptor Antagonists for the Prevention of CINV Number of Vials Sold in the U.S. by Quarter 700, , , , , , ,000 - Q1'13 Q2'13 Q3'13 Q4'13 Q1'14 Q2'14 Q3'14 Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Aloxi granisetron ondansetron Source: Symphony Health Solutions data,
9 93% of Palonosetron Units are Used Outside of Cisplatin Total U.S. palonosetron Units (2015) By Chemo Regimen 0.18 Units (Millions) Cisplatin Other Chemotherapy Source: Intrinsiq 2013 (for Aloxi units); Symphony 2015 (for proportion of chemo that is cisplatin) 9
10 Our Target Market Can be Reached by a Small but Focused Commercial Team Commercial launch to be highly-targeted with two key phases Phase 1 Targets (First months) ~1.4MM Units Phase 2 Targets ~1.1MM Units Phase 1 Targets Highly-concentrated 1 700K branded units (50%) in 70 practices (533 sites) Value clinical advances over 1 st generation 5-HT3s Prioritize branded agents Have shorter time-to-adoption Include 100% of MAGIC sites Symphony SNR data Schnadig et al. APF530 (granisetron injection extended-release) in a three drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016;12:
11 Heron s Commercial Plans will Address Potential Launch Barriers for Providers, Patients, and Payers Providers Patients Payers Objectives Establish SUSTOL clinical value & address objections Build differentiated value proposition Establish coverage confidence Optimize access Optimize access Action Plan First and only 5-HT3 with advanced, extended-release technology and 5-day CINV prevention in MEC and AC-based HEC regimens 1,2 Robust in-office and peer-to-peer education Comprehensive RN in-services with administration demonstration kits Performance-based contract designed to deliver sustained value Best-in-class reimbursement support services Extended payment terms Innovative stand by your drug program (qualified coverage denials) $0 co-pay for commercially insured patients Strong uninsured patient program Proactive payer engagement with traditionally restrictive plans Engagement between community practices and regional payers 1 SUSTOL is indicated for prevention of CINV due to MEC and AC combination chemotherapy. National clinical practice guidelines for antiemesis classify AC-based regimens as highly emetogenic. 2 NCCN
12 U.S. Commercial Organization is Poised for Launch U.S. Commercial Organization Marketing Sales Market Access GPO Account Team Phase 1 Targets (First months) ~1.4MM Units Payer Account Team MSLs / Nurse Educators 12 Source: Symphony SNR data 2015
13 HTX-019: IV Aprepitant Polysorbate 80-Free NK1 Receptor Antagonist for CINV Prevention 13
14 HTX-019 HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, an NK 1 receptor antagonist and is distinguished from EMEND IV, the only IV NK 1 receptor antagonist presently approved in the U.S., in that it does not contain polysorbate 80, which may cause infusion site reactions, hypersensitivity or other adverse reactions in some patients. Bioequivalency study comparing HTX-019 to EMEND IV (fosaprepitant) completed: Bioequivalence achieved for AUC Substantially fewer adverse events with HTX-019 Rapid development utilizing the 505(b)(2) registration pathway is anticipated to achieve NDA submission in 4Q2016 Direct competitor to the approximately 1 million units of EMEND IV used annually 14
15 15 HTX-019 is Bioequivalent to EMEND IV for Both Aprepitant and Total Aprepitant Equivalents
16 HTX-019 (IV aprepitant) for CINV: BE Study Safety Results 100 subjects received HTX-019 and EMEND IV in standard cross-over design SAFETY HTX-019 EMEND IV Events Patients Events Patients Total AEs 27 21% 54 28% AEs considered related 18 15% 52 28% SAEs Moderate AEs 0-6 2% AEs leading to discontinuations 0-2 2% Final dataset Conclusion: HTX-019 was better tolerated than EMEND IV, with 65% fewer AEs at least possibly related to treatment, no AEs of greater than mild severity, no premature discontinuations 16
17 POST-OPERATIVE PAIN PROGRAM HTX-011: Bupivacaine + Meloxicam in Proprietary Polymer 17
18 The Ideal Therapeutic for Post- Operative Pain The ideal therapeutic for post-operative pain would: Significantly reduce pain for several days after surgery Significantly reduce opioid use: Reduce total amount of opioids consumed Increase number of patients who NEVER need an opioid Demonstrate these benefits versus bupivacaine solution, the current standard of care Cover a wide range of surgeries, including where nerve block is preferred Require no/minimal injections with local administration, making it easy to administer and reducing the risk of inadvertent venous puncture Not be amenable to mixing with bupivacaine solution, reducing the chance of dosing errors and systemic toxicity 18
19 Market Opportunity for HTX-011 in Post-Operative Pain Management Procedures (Millions) Procedures Requiring Post-Operative Pain Relief Post-Operative Pain Market Share Last 12 Months % 3% 79% Bupivacaine Ropivacaine Bupivacaine Liposome ,539,647 Total Vials The number one reason cited by pharmacy directors for not including bupivacaine liposome on formulary is the insufficient advantage versus generic bupivacaine Decision Resources, Post-Operative Pain Pharmacor; 2 Symphony Health Solutions 12 months ended 6/30/16; 3 Decision Resources Survey of Pharmacy Directors Re: Post-Operative Pain Management (April 2014)
20 Biochronomer Bupivacaine Produced Significant Reductions in Pain in Preclinical Models 1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine Bupivacaine Liposome Injectable Suspension (2) Percentage of Maximal Force (60 gm) Tolerated by Animal HOURS 1. Post-operative pain model in pigs from Castle et al, 2013 EPJ 2. Human dose of bupivacaine liposome with 40% smaller incision 20 (n=4 pigs)
21 Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms Inflammation Produces an Acidic Environment Which Shifts the Balance to Ionized Form Unable to Penetrate Nerve Cell Membrane BUPH + BUPN + H + Outside membrane Inside membrane Nerve Cell Membrane BUPH + BUPN + H + The acidic environment associated with inflammation results in far less drug penetrating the nerve membrane and reduced anesthetic effects 1,2 With a pka of 8.1, bupivacaine is very sensitive to reduced ph Ueno, et al. J of Inflammation Research 1: Local anesthetic nerve penetration model adapted from Becker and Reed, Anesth Prog 53:
22 HTX-011 s Unique Combination of Bupivacaine and Meloxicam Produced Marked Anesthesia through 72 Hours 1 Pig Post-Operative Pain Model Percentage of Maximal Force (60 gm) Tolerated Saline Control Biochronomer Bupivacaine HTX-011 Bupivacaine Liposome Injectable Suspension (2) Biochronomer Meloxicam Hours 1. Post-operative pain model in pigs from Castle et al, 2013 EPJ 2. Human dose of bupivacaine liposome with 40% smaller incision 22 (n=4 pigs in each arm)
23 23 HTX-011 IS THE FIRST AND ONLY LONG-ACTING ANESTHETIC DESIGNED TO ADDRESS BOTH POST- OPERATIVE PAIN AND ACCOMPANYING INFLAMMATION
24 HTX-011 Study 208: Bunionectomy Study Design HTX-011A 200 mg HTX-011B 200 mg Bupivacaine Solution Saline Injection Closed wound (Nerve Block) Injection Open wound (Infiltration) Injection Closed wound (Nerve Block) Injection Open wound (Infiltration) Injection Closed wound (Nerve Block) Injection Closed wound 24
25 HTX : Demographics Characteristic Parameter HTX-011A HTX-011B Bupivacaine 200mg 200mg Solution Saline Age (Years) n Mean Minimum Maximum Gender n (%) Male 5 (15.6) 5 (16.1) 2 (13.3) 3 (20.0) Female 26 (81.3) 26 (83.9) 13 (86.7) 12 (80.0) Race n (%) Caucasian 19 (59.4) 25 (80.6) 8 (53.3) 6 (40.0) African American 12 (37.5) 4 (12.9) 6 (40.0) 8 (53.3) Other 1 (3.1) 2 (6.5) 1 (6.7) 1 (6.7) Ethnicity n (%) Hispanic 9 (28.1) 5 (16.1) 2 (13.3) 2 (13.3) Not Hispanic 23 (71.9) 26 (83.9) 13 (86.7) 13 (86.7) 25
26 HTX : Route of Administration Did Not Impact Efficacy Mean SPI 0-24 Hours HTX-011B 200mg Infiltration HTX-011B 200mg Nerve Block Bupivacaine Solution 50mg No significant difference between routes, with both routes of HTX-011B administration significantly better than placebo and bupivacaine solution Study confirms the significant benefit of HTX-011 given as a local infiltration (open wound injection) or Mayo Block (i.e., nerve block or closed wound infiltration)
27 HTX : Mean Pain Intensity Scores* HTX-011B Is Superior to the A Formulation** HTX-011B Is Our Phase 3 Clinical Candidate 8 7 Mean Pain Intensity Scores Hours HTX-011A 200mg HTX-011B 200mg Bupivacaine Solution 50mg Saline Placebo 27 *LOCF method used to account for missing data, no adjustment for use of rescue medications **Results from nerve block and open wound injection combined
28 HTX : Mean Pain Intensity Scores* HTX-011B Via Nerve Block Is Significantly Better than Placebo or Bupivacaine Solution Mean Pain Intensity SPI 0-24 H v P: p< H v B: p< HTX-011B Via Nerve Block SPI H vs P: p=0.013 H vs B: p=0.003 SPI 0-48 H v P: p< H v B: p< Hours SPI H vs P: p=0.291 H vs B: p=0.178 SPI 0-72 H v P: p= H v B: p= HTX-011B 200mg Nerve Block (H) Bupivacaine Solution 50 mg (B) Saline Placebo (P) SPI 0-96 H v P: p=0.004 H v B: p= *LOCF method used to account for missing data, no adjustment for use of rescue medications
29 HTX : Mean Pain Intensity Scores* HTX-011B Via Open Wound Injection Is Significantly Better than Placebo or Bupivacaine Solution Mean Pain Intensity SPI 0-24 H v P: p< H v B: p< HTX-011B Via Injection SPI H vs P: p=0.162 H vs B: p=0.037 SPI 0-48 H v P: p= H v B: p= Hours SPI H vs P: p=0.115 H vs B: p=0.345 SPI 0-72 H v P: p=0.002 H v B: p=0.004 HTX-011B 200mg Infiltration (H) Bupivacaine Solution 50 mg (B) Saline Placebo (P) SPI 0-96 H v P: p=0.005 H v B: p= *LOCF method used to account for missing data, no adjustment for use of rescue medications
30 HTX : Secondary Endpoint Mean Use of Opioid Rescue Medication Mean opioid Rescue Over Time Placebo (P) Bupivacaine Solution (B) HTX-011B 200 mg Percent Reduction 0 24 hours 20.3mg 15.9mg 5.2mg p< v P P< v B 74% v P 67% v B 0 48 hours 31.1mg 28.5mg 13.3mg p= v P p=0.001 v B 57% v P 53% v B 0 72 hours 37.7mg 35.8mg 17.7mg p=0.003 v P p=0.007 v B 53% v P 51% v B hours 38.1mg 35.8mg 17.9mg p=0.003 v P p=0.008 v B 53% v P 50% v B
31 HTX : Secondary Endpoints -Mean Time to First Opioid Increased by 716% -Significant Increase in Opioid-Free Patients Mean Time to First Opioid Rescue Medication Percent of Patients Opioid Free for First 24 Hours Percent of Patients Opioid Free for First 96 Hours Placebo (P) 3.8hr Bupivacaine Solution (B) 11.6hr 0% 7% HTX-011B 200 mg 31.0hr p< vs P p=0.037 vs B 32% p=0.019 vs P 0% 7% 16% 31
32 HTX-011 Study 202: Herniorrhaphy Study Design HTX-011B 200mg Injection Instillation Part B HTX-011B 400mg Injection Instillation Saline Injection 32
33 HTX B: Demographics Characteristic Parameter HTX-011B 200mg N = 31 HTX-011B 400mg N = 30 Saline Part B N = 31 Age (Years) Mean Minimum Maximum Gender n (%) Male 31 (100) 23 (96) 30 (97) Female 0 (0) 1 (3) 1 (3) Race n (%) Caucasian 29 (94) 25 (83) 24 (77) African American 2 (6) 2 (7) 7 (23) Other 0 (0) 3 (10) 0 (0) Ethnicity n (%) Hispanic 13 (42) 12 (40) 12 (39) Not Hispanic 18 (58) 18 (60) 19 (61) 33
34 Instillation and Injection Reduced Pain Equally Well Mean SPI HTX-011B 400mg Injection (N=14) HTX-011B 400mg Instillation (N=16) Saline Placebo (N=31) 34
35 HTX-011: Instillation Is Easier and Potentially Safer 35 Compared to injection, instillation into the incision site is: Easier to administer and less invasive, avoiding up to 10 or more injections into the skin with large operations Safer, reducing the risk of venous puncture
36 Study 202: Mean Pain Intensity Scores HTX-011B 400mg Significantly Better than Placebo Through 48 hours 8 7 SPI p= Mean Pain Intensity SPI 0-24 p= SPI 0-48 p=0.025 SPI 0-72 p=0.082 SPI 0-96 p= HTX-011B 200mg HTX-011B 400mg Saline Placebo 36 *LOCF method used to account for missing data, no adjustment for use of rescue medications P-values are for the 400 mg dose
37 Study 202: Secondary Endpoints Percent of Patients Requiring No Opioid Substantially Increased Consistent with the significant reductions in pain observed with HTX-011B, opiate use was also reduced: Percent of patients who required no opioid rescue medication for the 96 hour study period substantially increased (24.1% versus 6.5%) Mean total opioid consumption decreased by 22.4% through 96 hours post-surgery 37
38 Summary of Treatment-Emergent Adverse Events (TEAEs) in Study 202* Preferred Term HTX-011B 200 mg (N=31) HTX-011B 400 mg (N=30) Saline Placebo (N=31) Any TEAE 12 (38.7%) 10 (33.3%) 16 (51.6%) >1 TEAE in any treatment arm Nausea 2 (6.5%) 5 (16.7%) 4 (12.9%) Headache 3 (9.7%) 3 (10.0%) 0 Constipation 3 (9.7%) 1 (3.3%) 5 (16.1%) Hypersensitivity (6.5%) *Part B with HTX-011B, our Phase 3 clinical candidate 38
39 Phase 3 Program Designed to Demonstrate HTX-011 s Broad Utility and Clear Advantage over Standard of Care Heron s Phase 3 program for HTX-011 will: Include multiple types of surgical procedures Compare HTX-011 not only to placebo but also to bupivacaine solution, the current standard of care for postoperative pain Include studies administering HTX-011 by infiltration and nerve block Include studies administering HTX-011 by instillation and injection Heron s target is to submit a New Drug Application based on this comprehensive program in
40 HTX-011 s Emerging Profile In clinical studies, HTX-011 has been shown to: Significantly reduce pain for several days after surgery Significantly reduce opioid use: Reduced total amount of opioids consumed Increased number of patients who NEVER need an opioid Demonstrate these benefits versus bupivacaine solution, the current standard of care Cover a wide range of surgeries, including where nerve block is preferred Require no/minimal injections, making it easy to administer and reducing the risk of inadvertent venous puncture Not be amenable mixing with bupivacaine solution, reducing the chance of dosing errors and systemic toxicity 40
41 Financial Summary Entered into loan agreement for up to $100M in August 2016 Summary Statement of Operations (In thousands, except per share data) Six Months Ended June 30, 2016 Revenue $ Operating expenses 76,378 Other income (expenses) (293) Net loss $ (76,671) Net loss per share 1 $ (2.09) Condensed Balance Sheet Data (In thousands) June 30, 2016 Cash, cash equivalents and short-term investments $ 74,643 Pro-forma cash, cash equivalents and short-term investments 2 $124,643 Total assets $ 85,731 Total stockholders equity $ 57, Based on 36.6 million weighted average common shares outstanding for the period ended June 30, There were 39.0 million shares outstanding as of June 30, Including first close of $50 million on August 5, 2016
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