SEC Filing - Heron Therapeutics

Heron Therapeutics, Inc.

Date: December 10, 2014

/s/ Esme C. Smith

Esme C. Smith

Vice President & General Counsel

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Form 8-K

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) December 10, 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.

The Company will deliver a corporate presentation at the Oppenheimer 25^th Annual Healthcare Conference on December 10, 2014. The slides from the presentation are attached hereto as Exhibit 99.1. 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		Corporate Presentation, dated December 2014

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.

EX-99.1

Company Update

December 2014

Exhibit 99.1

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 the development, regulatory approval, manufacture,

launch and acceptance of new products, completion of clinical studies and

the results thereof, the ability to establish strategic 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.

Status of Development Programs

Preclinical

Phase 1

Phase 2

Phase 3

NDA

Intravenous

for CINV

CINV: Acute and Delayed after MEC, and Acute HEC

SUSTOL

(APF530)

SUSTOL

(APF530)

HTX-019

HTX-011

Delayed HEC

Will be evaluated in soft

tissue, nerve block, and

orthopedic indications

Pain Program

HTX-003

30-Day Buprenorphine for

chronic pain and addiction

CINV FRANCHISE

CINV Highlights

•

SUSTOL®

(granisetron injection, extended release), is a long-acting, injectable

product for the prevention of chemotherapy-induced nausea and vomiting

(CINV)

–

1,341-patient,

randomized,

controlled,

Phase

study

demonstrated

activity

in acute and delayed onset CINV after moderately emetogenic

chemotherapy, and acute onset CINV after highly emetogenic chemotherapy

(HEC)

–

On-going 1000 patient study in patients receiving HEC is designed to obtain

“delayed

HEC”

indication;

injectable

5-HT

agent

currently

approved

for delayed HEC

•

HTX-019

is a proprietary intravenous (IV) formulation of aprepitant, an

receptor

antagonist

and

distinguished

from

the

only

receptor

antagonist presently approved in the U.S. in that it does not contain polysorbate

80, which may cause hypersensitivity reactions in some patients

–

Rapid development utilizing the 505(b)(2) registration pathway is anticipated

to achieve NDA submission in 1H2016

5-Day Profile: APF530 Pharmacokinetics

Granisetron is released rapidly following injection of APF530 and continues to be released

for 5-days, providing long-acting coverage for CINV

Minimum

therapeutic

concentration of

granisetron*

*Data from patent application 20120258164 for transdermal granisetron

All subjects (n= 18)

mean ±

SEM

120

144

168

Time after Dosing (h)

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

Primary Efficacy Results: Complete

Response

Patients Receiving Moderately

Emetogenic Chemotherapy

Acute

Delayed

APF530 10mg

Acute

Delayed

Difference in Complete Response

APF530-Aloxi (97.5% CI)

-15

-10

-5

75.0

76.9

57.2

58.5

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

Primary Efficacy Results: Complete

Response

Patients Receiving Highly

Emetogenic Chemotherapy

Difference in Complete Response

APF530-Aloxi (98.33% CI)

-15

-10

-5

Acute

Delayed

APF530 10mg

Acute

Delayed

80.7

81.3

64.3

67.1

100

Safety Summary

Safety

results

with

the

dose

APF530

studied

separate

arm

the

phase

study

are

not

included

>90%

injection

site

reactions

were

reported

mild;

one

patient

discontinued

due

injection

site

reaction

Cycle 1 Safety Results

APF530

Aloxi 0.25 mg

Drug Related Serious Adverse Events

Discontinued Due to Adverse Event

0.2

Frequent Adverse Events

Gastrointestinal Disorders

Constipation

Diarrhea

Abdominal pain

15.4

9.4

2.8

13.4

8.4

6.0

Nervous System

Headache

10.0

9.7

Injection Site

Placebo (NaCl)

Bruising

Erythema (redness)

Nodule (lump)

Pain

19.9

10.9

10.7

7.1

8.9

3.0

0.6

1.1

FDA-Requested

ASCO

2011

Reanalysis

Improves Difference Between SUSTOL and

Aloxi in HEC Patients

Protocol Specified HEC Population

ASCO 2011 Guideline HEC Population

Acute

Delayed

Acute

Delayed

100

CR Rates by Treatment

Chemotherapeutic Regimen

APF530 10 mg

Aloxi 0.25 mg

Moderately

Emetogenic

Acute

Cyclophosphamide/Doxorubicin

70.7%

65.7%

All other regimens

84.4%

85.0%

Delayed

Cyclophosphamide/Doxorubicin

47.4%

46.3%

All other regimens

72.9%

70.0%

Highly

Emetogenic

Acute

Cisplatin regimens

81.1%

75.5%

Carboplatin/Paclitaxel

85.4%

89.8%

All other regimens

75.4%

67.6%

Delayed

Cisplatin regimens

66.0%

60.4%

Carboplatin/Paclitaxel

70.8%

71.4%

All other regimens

65.2%

57.4%

Largest Differences Between Arms is Seen

With Most Difficult Chemo Regimens

•

Data from post-hoc analysis. Not statistically significant.

•

Highlighted HEC regimens were considered HEC in both protocol specified Hesketh and 2011

ASCO Guidelines

Response Rates With Chemotherapy Classified

as HEC by Both Hesketh and 2011 ASCO*

*Cisplatin, carmustine, dacarbazine, dactinomycin, mechlorethamine, streptozotocin

SUSTOL reflects 9-11% greater response rate in the most emetogenic chemotherapy

69%

55%

78%

66%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Acute

Delayed

Aloxi

SUSTOL

A Delayed-HEC Indication Would Provide

Clear Differentiation in an Important

Segment of the CINV Market

IntrinsiQ data from July 2012 –

June 2013

HEC regimens account for

~20% (500K) of

palonosetron administrations

This is the same segment of

the

CINV

market

where

receptor antagonists are

extensively used

HEC

MEC

LEC

Minimal

Distribution of Aloxi

Sales*

Phase 3 “MAGIC”

Study

1000 patients

scheduled to receive

HEC* randomized

1:1

Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d 1

+ fosaprepitant 150 mg IV d 1 + DEX

+ placebo SC d1

APF530 500 mg SC d 1

+ fosaprepitant 150 mg IV d 1 + DEX

+ placebo IV d 1

Cycle 1

All subjects will receive dexamethasone 12 mg IV on day 1 and 8 mg PO BID on days 2-4

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.

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

New SUSTOL Study Strategically Designed

Based on Previous Results

^^Average

Complete

Response

rate

improvement

when

adding

NK-1

5-HT3

and

Dex

~15

20%

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

Projected

Response

with addition

of NK1

Study

powered

to show 10%

difference:

65% vs 75%

APF530 + Dex

+ Fosaprepitant**

APF530+Dex

Ondansetron + Dex

+ Fosaprepitant*

Ondansetron + Dex*

75%

Standard of Care

Phase 3 Study

HEC Study

67%

65%

45%

Study powered for a 10% difference between arms

20% difference is expected with the addition of fosaprepitant,

87%

100

HEC Study Update

•

>150 site locations have drug

•

Expect to complete enrollment in

1Q2015, with an NDA resubmission

shortly thereafter

•

FDA has previously indicated that a

positive outcome from this study would

be sufficient to obtain “delayed-HEC”

indication

SUSTOL Has the Potential to be the Next

Generation 5-HT

Receptor Antagonist

5-HT

RAs

generation

Products

ondansetron

granisetron

palonosetron

SUSTOL

Duration of

action

Short acting

~ 8 hr half-life

Longer acting

~40 hr half-life

Long acting

PK profile 5-7 days

Indications

Prevention of CINV in

emetogenic chemo including

high-dose cisplatin

MEC –

acute & delayed CINV

HEC –

acute CINV

MEC –

acute & delayed CINV

HEC –

acute & delayed CINV*

*Obtaining delayed HEC dependent on results of ongoing SUSTOL trial

SUSTOL REGULATORY

STATUS

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

•

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 the ASCO

2011 guidelines for categorization of MEC and HEC

–

Received Complete Response Letter March 2013 raising three main

issues:

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

complete,

with

secondary

benefit

improvement

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 will include MAGIC study, which is

expected to complete enrollment in 1Q2015, with a

resubmission shortly thereafter

CINV FRANCHISE

COMMERCIAL OPPORTUNITY

Commercial Opportunity Summary

Market

•

Heron has the opportunity to establish a long-term, dominant position in a CINV

market targeting 3.6M units of IV 5HT-3 and NK-1 annually

•

The NK-1 market grew 10% YOY in 2013 with significant opportunity for

increased penetration into MEC regimens

Competitive

Landscape

•

New branded, injectable agents will be well-positioned to gain significant share

as current market leaders (Aloxi, EMEND) lose patent protection

•

SUSTOL positioned to be the only branded injectable 5HT3 on the market following Aloxi’s

patent expiry in 2015

•

HTX019 anticipated to be similarly positioned following EMEND’s patent expiry in 2019

Go-To-Market

Strategies

•

Differentiate SUSTOL and HTX019 clinically to drive uptake

•

SUSTOL targeted to be the first and only injectable 5HT3 indicated for the prevention of acute

and

delayed

CINV

both

MEC

and

HEC

•

HTX019 has potential to differentiate vs. IV EMEND based on polysorbate 80-free formulation

•

Leverage a highly synergistic CINV portfolio to maximize return on investment

•

~600 practices account for ~90% of both Aloxi and IV Emend use in clinic segment

•

SUSTOL-targeted practices are the highest users of IV EMEND

•

Highly leveraged cost effective commercial footprint

Heron has the opportunity to establish a long-term,

dominant position in a CINV market that has over

3.6M penetrable units

Aloxi

Emend

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

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

Injectable Drugs for the Prevention of CINV

Number of Package Units Sold by Quarter

ALOXI

ANZEMET

KYTRIL

KYTRIL Generic (GRANISETRON)

ZOFRAN

ZOFRAN Generic (ONDANSETRON)

EMEND

Data is Package Units; Ondansetron units reflect only 2 mg/ml and 32mg/50 ml strength sizes

New branded, injectable agents will be well-

positioned to gain significant share as current

market leaders (Aloxi, EMEND) lose patent protection

Candidate

Class

Indication

Sponsor

Possible

Launch

AKYNZEO

Oral FDC combines netupitant

(NK-1) with palonosetron

(5HT3)

Prevention of CINV in MEC/HEC

Eisai /

Helsinn

Launched Q4 2014

Generic

palonosetron

IV 5-HT3

MEC –

acute & delayed CINV

HEC –

acute CINV

TBD

(multiple)

Q4 2015 (TBD)

Ongoing litigation

Rolapitant

Oral / IV NK-1

Prevention of delayed onset CINV in

MEC/HEC (to be used in combination

with 5-HT3)

Tesaro

Oral mid-2015

IV Q3 2016

Generic

fosaprepitant

IV NK-1

Prevention of CINV in MEC/HEC (to be

used in combination with 5-HT3)

TBD

(multiple)

Q1 2019

2014

2015

2016

AKYNZEO

(oral)

Rolapitant??

(oral)

Rolapitant??

(IV)

2017

2018

2019

fosaprepitant

patent expiry

palonosetron

patent expiry

SUSTOL would be the first and only injectable 5HT3

indicated for acute and delayed CINV in both

MEC

and HEC favored by more than 50% of oncologists

Attribute

Favor IV Aloxi (1-2)

No Preference (3)

Favor SUSTOL (4-5)

Avg. (N=66)

Effective for prevention of delayed CINV in assoc. with HEC

3.65

Is long-acting, with an extended PK profile

3.62

Provides consistently durable efficacy for over 5 full days

3.53

Effective for prevention of delayed CINV in assoc. with MEC

3.48

Has low rates of breakthrough CINV

3.47

Minimizes amount of rescue medication required

3.44

Demonstrates sustained efficacy over multiple chemo cycles

3.44

Effective for prevention of acute CINV in assoc. with HEC

3.32

Well tolerated, with a low risk of side effects

3.32

Effective for prevention of acute CINV in assoc. with MEC

3.27

MD PMR Q29: Please rate the extent to which you favor SUSTOL versus IV Aloxi (palonosetron) on each of the following attributes using a 5-

point scale, where 1= Strongly favor IV Aloxi (palonosetron) over SUSTOL and 5 = Strongly favor SUSTOL over IV Aloxi (palonosetron) [SS]

11%

52%

59%

55%

50%

42%

41%

47%

38%

33%

38%

33%

39%

45%

50%

52%

50%

56%

61%

HEC Regimens Represent a Significant Market

Opportunity for SUSTOL and HTX-019

IntrinsiQ

data

from

July

2012

–

June

2013

497,256

1,463,558

451,490

111,696

HEC

MEC

LEC

Minimal

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

497,256

317,915

188,988

200,000

400,000

600,000

800,000

1,000,000

1,200,000

Annual HEC

administrations

Untreated with

IV 5HT3

Treated with

generic IV

5HT3

Treated with

Aloxi

HEC regimens account for ~20% (500K)

of palonosetron administrations

Of all HEC administrations, ~20% are given

without

concomitant

5-HT

–

inconsistent

with clinical guidelines

POST-OPERATIVE PAIN PROGRAM

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

Biochronomer Bupivacaine/Meloxicam

Significantly Superior to EXPAREL

at 24-72 Hours

Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ

Study

compared

<½

expected

human

dose

Biochronomer

bupivacaine/meloxicam

formulation

the

human dose of EXPAREL (40% smaller incision used with EXPAREL)

Pig Post-Operative Pain Model

(n=4 pigs, except at 120 hrs for Study #2: preliminary results from 2 animals)

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

120

HOURS

Saline Control (1)

Biochronomer Bupivacaine (1)

Biochronomer Ropivacaine (1)

Biochronomer Bupivacaine + Meloxicam (2)

Exparel (2)

Next Steps for Post-Operative Pain

Program

•

Phase

enabling

toxicology

completed

–

issues

•

Complete Phase 1 SAD in 1Q15

•

Quickly initiate Phase 1b/2 studies 1H15 based on

Phase 1 SAD

•

Completing toxicology for nerve-block and orthopedic

indications to allow expansion of program

POST-OPERATIVE PAIN PROGRAM

COMMERCIAL OPPORTUNITY

U.S. Post-Operative Pain Market

Source: Decision Resources, Post-Operative Pain Pharmacor, May 2006;

Decision Resources, Acute Pain, December 2012

•

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

procedures

anticipated

increase

per

year

driven

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)

2012 Total: $3.1B

2021 Total: $3.6B

Strong

opioid

analgesics;

53%

Simple

analgesics;

11%

Opioids;

Selective

COX-2

inhibitors;

Local

anesthetics;

Traditional

NSAIDs; 9%

Antiepileptic

Drugs

(AED);

Strong

opioid

analgesics;

51%

Simple

analgesics;

13%

Dual-Acting

Opioids;

Selective

COX-2

inhibitors;

Local

anesthetics;

11%

Traditional

NSAIDs;

Antiepileptic

Drugs

(AED);

Novel

Emerging

Agents;

Dual-Acting

72 hour Duration of Action Seen as “Ideal”

by Physicians, With 48 hours Minimally

Acceptable

Ideal

Duration

Efficacy

for

Long-

Acting Local Anesthetic

Minimally

Acceptable

Duration

Efficacy

for

Long-Acting

Local

Anesthetic

Source: Decision Resources Post-Operative Pain Physician Research

Initiative

2014

(N=30

qualitative

interviews;

N=184

quantitative

survey)

48 hours

27%

72 hours

46%

4 days

5 days

>5 days

48 hours

45%

72 hours

11%

12%

44%

Hours

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

Percentage of physicians indicating how frequently they expect

to use long-acting local anesthetics in the future

“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

Source: Decision Resources Post-Operative Pain Physician Research

Initiative

2014

(N=30

qualitative

interviews;

N=184

quantitative

survey)

10%

53%

60%

45%

62%

58%

66%

44%

60%

50%

41%

49%

47%

49%

37%

33%

49%

29%

36%

37%

28%

53%

34%

35%

43%

54%

48%

46%

48%

20%

40%

60%

80%

100%

Cesarean Section

Cholecystectomy (outpatient)

Arthroplasty knee (outpatient)

Other non-OR therapeutic

procedures on musculoskeletal..

Treatment, fracture or dislocation

of hip and femur (inpatient)

Other fracture and dislocation

procedure

Repair of toe

Arthroplasty shoulder

Other therapeutic procedures on

muscles and tendons

Cholecystectomy (inpatient)

Arthroplasty other than hip, knee,

shoulder, or elbow

Hernia (outpatient)

Hip replacement, total and partial

Hernia (inpatient)

Arthroplasty knee (inpatient)

Less frequently

Same amount

More frequently

HTX-003

LONG-ACTING BUPRENORPHINE

FOR

CHRONIC

PAIN

AND

ADDICTION

30-Day Buprenorphine

Comparison to Competitive Products in Development*

*RB Pharma is from US2013/0210853; Camurus data from US2013/0190341

Repeat Dose Model*

Therapeutic

range

*Prediction based on 15 mg dosed monthly

Excellent PK profile for once monthly dosing

Cmax achieves steady state by second dose

Partnering Opportunity for Long-

Acting Buprenorphine Products

•

Projected sales of products for opioid addiction to reach $3B by

2020

•

Recent deals for buprenorphine products show significant interest in the

space:

•

Titan license of Probuphine to Braeburn (12/17/2012)

•

6 month sub-dermal implant for opioid addiction with NDA submitted

•

$15.7M upfront, $180M milestones with double-digit royalties

•

Camarus license of CAM2038, long acting buprenorphine to Braiburn (11/20/2014)

•

Phase 2 program for opioid addiction and pain, with exclusive rights for North

America and option in Asia, Camurus retains ROW

•

$20M upfront, $131M in milestones with mid-teen royalty

HTX-003 Target Product Profile

•

30-day zero-order release of buprenorphine with single sub-Q injection

•

Low peak to trough variation allows for stable drug levels

•

Administered

medical

professional

with

very

low

potential

for

abuse

patients

Financial Summary

Summary Statement of Operations

(In thousands, except per share data)

Nine Months Ended

September 30, 2014

Revenue

$ –

Operating expenses

55,066

Other income (expenses)

(677)

Net loss

$ (55,743)

Net

loss

per

$ (2.17)

Condensed Balance Sheet Data

(In thousands)

September 30, 2014

Cash and cash equivalents

$ 86,212

Total assets

$ 92,282

Total stockholders’

equity

$ 81,008

Based on 25.7 million weighted average common shares outstanding for the period ended

September 30, 2014 (1-for-20 reverse stock split in JAN2014).