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):

January 10, 2014

 

 

Heron Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-33221   94-2875566

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS 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

 

 

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On January 10, 2014, Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) (the “Company”) paid annual bonuses for fiscal 2013 to its current Chief Executive Officer, Chief Financial Officer and the following “named executive officers” included in the Company’s proxy statement on Schedule 14A for the 2013 Annual Meeting of Stockholders. Bonus amounts below have been prorated as appropriate based on each officer’s applicable start date of employment.

 

Name    Title    Bonus Payment  

Barry D. Quart, Pharm. D.

   Chief Executive Officer    $ 240,637   

Robert Rosen

   President    $ 317,188   

Brian Drazba

   Vice President, Finance and Chief Financial Officer    $ 14,250   

Mark S. Gelder, M.D.

   Senior Vice President, Chief Medical Officer    $ 162,500   

Stephen R. Davis

   Executive Vice President, Chief Operating Officer    $ 133,333   

On January 13, 2014, the Company issued a press release announcing that Craig Johnson, John Poyhenen, and Kimberly Manhard were appointed as directors on Friday, January 10, each to serve until their successors are elected and qualified. Craig Johnson was named as the chairman of the Company’s Audit Committee. John Poyhenen was named as a member of the Company’s Audit Committee and chairman of the Compensation Committee. Kimberly Manhard was named as a member of the Company’s Audit Committee and Compensation Committee.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

Effective as of January 13, 2014, the Company amended its Certificate of Incorporation to: (i) change its name to Heron Therapeutics, Inc. (the “ Name Change ”), and (ii) effect a 1-for-20 reverse split of its outstanding common stock (the “ Reverse Split ”). The Name Change and Reverse Split were approved by the Company’s stockholders on September 19, 2013. The Name Change and Reverse Split were effected with the filing of a Certificate of Amendment with the Delaware Secretary of State (the “ Certificate of Amendment ”). Additionally, as a result of the Reverse Split, the total authorized shares of common stock were reduced to 75,000,000 shares. No fractional shares will be issued in the Reverse Split and stockholders will instead be entitled to receive the cash value of any fractions of shares that would have been issued as a result of the Reverse Split. A copy of the Certificate of Amendment is attached hereto as Exhibit 3.1.

Item 8.01 Other Events.

On January 13, 2014, the Company updated its corporate summary, in the form attached as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.    Description
3.1    Certificate of Amendment
99.1    Corporate Summary, dated January 13, 2014

SIGNATURES

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: January 13, 2014     By:  

/s/ Stephen R. Davis

     

Stephen R. Davis

Chief Operating Officer

Exhibit Index

 

Exhibit No.

  

Description

3.1    Certificate of Amendment
99.1    Corporate Summary, dated January 13, 2014

Exhibit 3.1

CERTIFICATE OF AMENDMENT

TO THE CERTIFICATE OF INCORPORATION OF

A.P. PHARMA, INC.

A.P. Pharma, Inc., a corporation duly organized and existing under the General Corporation Law of the State of Delaware (the “ Corporation ”), does hereby certify:

FIRST: That Article I of the Certificate of Incorporation of the Corporation is hereby amended in its entirety as follows:

“I: Name. The name of the corporation is Heron Therapeutics, Inc.”

SECOND: That, upon the Effective Time, Section A of Article IV of the Certificate of Incorporation of the Corporation shall be amended and restated in its entirety as follows:

“A.  Authorized Capital . The corporation is authorized to issue two classes of shares of stock to be designated, respectively, “preferred” and “common.” The total number of shares which the corporation is authorized to issue is Seventy Seven Million Five Hundred Thousand (77,500,000). The number of common shares authorized to be issued is Seventy Five Million (75,000,000), each such share to have a par value of $0.01 (“ Common Stock ”), and the number of preferred shares authorized to be issued is Two Million Five Hundred Thousand (2,500,000), each such share to have a par value of $0.01 (“ Preferred Stock ”).”

THIRD:  That, upon the Effective Time, Article IV of the Certificate of Incorporation of the Corporation shall be amended by adding at the end of Section A the following new sentences:

“Effective as of the Effective Time, as defined in the Certificate of Amendment filed with the Delaware Secretary of State on January 9, 2014, each 20 outstanding shares of Common Stock of the Corporation shall be combined and converted automatically into one share of Common Stock. In lieu of any fractional shares to which a holder would be otherwise entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of one share of Common Stock (pre-reverse-split), as determined by the Board of Directors of the Corporation. The Common Stock issued in this exchange (post-reverse stock split) shall have the same rights, preferences and privileges as the Common Stock (pre-reverse stock split).”

FOURTH:  The amendment to the Certificate of Incorporation of the Corporation herein was duly adopted by this Corporation’s Board of Directors in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware (the “ DGCL ”). A special meeting of stockholders was duly called upon notice in accordance with Section 222 of the DGCL and held on September 19, 2013, at which meeting the necessary number of shares were voted in favor of the proposed amendments. The stockholders of the Corporation duly adopted this Certificate of Amendment.

FIFTH:  The amendment to the Certificate of Incorporation of the Corporation herein shall be effective January 13, 2014 at 12:01 a.m., Eastern Time (the “ Effective Time ”).

IN WITNESS WHEREOF , said Corporation has caused this Certificate of Amendment to be executed by its duly authorized officer this 9 th day of January, 2014.

 

/s/ Barry D. Quart, Pharm.D.

Name: Barry D. Quart, Pharm.D.

Title: Chief Executive Officer
Company Update
January 13, 2014
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
Exhibit 99.1

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
2
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.

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
3
Barry D. Quart, PharmD
Chief Executive Officer
Ardea Biosciences
Agouron Pharmaceuticals
Pfizer
Robert Rosen
President &
Chief Commercial Officer
Bayer Healthcare
Sanofi-Synthèlabo
Imclone
Stephen Davis
Chief Operating Officer
Ardea Biosciences
Neurogen
Mark Gelder, M.D.
Senior Vice President &
Chief Medical Officer
GE Healthcare
Bayer Healthcare
Wyeth
Paul Marshall
Senior Vice President
Technical Operations
Amylin
Amgen
Baxter International
Brian Drazba
Vice President, Finance &
Chief Financial Officer
ISTA Pharmaceuticals
Insight Health Corp
Arthur Andersen & Co
Senior Management

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
4
Highlights
•
Lead product candidate, SUSTOL™
(formerly known as APF530), is long-acting,
injectable product for chemotherapy-induced nausea and vomiting (CINV)
–
Incorporates
widely
used
5-HT3
antagonist
-
granisetron
(Kytril
®
)
–
5-day delivery profile
–
Reduces
both
acute-
and
delayed-onset
CINV
with
single
injection
–
Patent coverage into 2024; however, effective exclusivity actually longer due to polymer
•
SUSTOL shown to be non-inferior to market leader Aloxi
®
–
1,341-patient, randomized, controlled, Phase 3 study
•
SUSTOL targets a large market opportunity, with approximately 7 million doses of
chemotherapy annually in US alone*
–
Recent competitive setbacks could enhance commercial uptake
–
Could be second, long-acting, injectable product on market
•
Plans to leverage our Biochronomer™
drug delivery technology, development
capacity and commercial expertise for other opportunities:
–
Long-acting anesthetic for post-surgical pain
–
Double and Triple-combination for CINV is under evaluation
–
Potential for several others
*TDR August 2006 internal report

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
SUSTOL CLINICAL SUMMARY

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
*Data from patent application 20120258164 for transdermal granisetron
Minimum
therapeutic 
concentration of
granisetron*
0
5
10
15
20
0
24
48
72
96
120
144
168
Time after Dosing (h)
All subjects (n= 18)
mean ±
SEM
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
6

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
7
APF530 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 or highly emetogenic)
•
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
–
A
±15% margin was used to establish non-inferiority

8
Primary Efficacy Results: Complete
Response
Patients Receiving Moderately
Emetogenic Chemotherapy
APF530 10mg
Acute
Delayed
Difference in Complete Response
APF530-Aloxi (97.5% CI)
-15
-10
-5
0
5
10
15
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
Acute
Delayed
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
9
Primary Efficacy Results: Complete
Response
Patients Receiving Highly
Emetogenic Chemotherapy
Difference in Complete Response
APF530-Aloxi (98.33% CI)
-15
-10
-5
0
5
10
15
Acute
Delayed
APF530 10mg
Acute
Delayed
-
+
0
10
20
30
40
50
60
70
80
90
100
80.7
81.3
64.3
67.1

Safety Summary
•
Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included
•
>90% of injection site reactions
were
reported
as
mild;
one
patient
discontinued
due
to
injection
site
reaction
Cycle 1 Safety Results
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
Diarrhea
Abdominal pain
72
44
13
15.4
9.4
2.8
62
39
28
13.4
8.4
6.0
Nervous System
Headache
47
10.0
45
9.7
Placebo (NaCl)
Bruising
Erythema (redness)
Nodule (lump)
Pain
93
51
50
33
19.9
10.9
10.7
7.1
41
14
3
5
8.9
3.0
0.6
1.1
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
10
APF530
10
mg
1
Injection
Site
2
1
2

FDA
Requested
ASCO
2011
Reanalysis
Improves Difference Between SUSTOL and
Aloxi
Protocol Specified HEC Population
ASCO 2011 Guideline HEC Population
81
81
64
67
0
10
20
30
40
50
60
70
80
90
100
Acute
Delayed
67
75
51
56
0
10
20
30
40
50
60
70
80
90
100
Acute
Delayed
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
11

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
12
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
1
•
1
Data from post-hoc analysis. Not statistically significant.
•
Highlighted HEC regimens were considered HEC in both protocol specified Hesketh and 2011
ASCO Guidelines

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
13
Summary of Clinical Results
•
Bio-erodible polymer technology releases granisetron to prevent CINV
over at least 5 days
•
Large, randomized, Phase 3 study conducted: APF530 10 mg showed
non-inferiority to Aloxi
–
For both acute-
and delayed-onset CINV
–
With both moderately and highly emetogenic chemotherapy
•
APF530 was well-tolerated
–
Incidence of adverse events comparable to Aloxi
–
Injection site reactions where predominately mild
•
Good response rates were observed in difficult chemotherapy regimens
•
Efficacy was maintained with reanalysis using ASCO 2011 guidelines
and through multiple cycles of chemotherapy
•
TQT study showed APF530 has no clinically significant effect on QT;
differentiated from Zofran(ondansetron) and Anzemet(dolasetron)

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
SUSTOL REGULATORY
STATUS

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
15
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 the ASCO
2011 guidelines for categorization of MEC and HEC

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
16
New Management Team Is Addressing
the CRL
•
Chemistry, Manufacturing, and Controls
–
Sites with PAI issues are being eliminated from the supply chain, with work
transferred to 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 being validated
–
Plan to produce three validation batches of finished product in advance of re-
filing to supply Human Factors Study
•
Human Factors Validation Study
–
Will be conducted as soon as commercial material available
•
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 now planned for late 1Q2014

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
SUSTOL LIFE-CYCLE MANAGEMENT
PLANS TO OBTAIN POST-APPROVAL
INDICATION FOR “DELAYED HEC”

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
18
Planned
Phase
3
“Delayed”
HEC
Study
Schematic
Cycle 1
1000 patients
scheduled to receive
HEC* randomized
1:1
Ondansetron  0.15 mg/kg
IV (up to 16 mg IV) d1 +
Fosaprepitant 150 mg IV
d1 + Placebo SC d1
SUSTOL SC  d1 +
Fosaprepitant 150 mg IV
d1 + Placebo IV d1
1)
All subjects will receive dexamethasone 12 mg IV on day 1 and 8 mg PO on days 2-4
2)
All
subjects
will
be
allowed
to
receive
“rescue”
medications
as
needed
at
the
discretion
of
their
treating physician
* HEC agents as defined in the 2011 ASCO CINV Guidelines
•
Study design has been accepted by FDA for obtaining expanded
indication
•
Study is powered to show superiority (10% difference) to three drug 
“standard of care”
for HEC
•
Study planned to complete late 2014

New SUSTOL Study Has a High Likelihood of
Success Based on Previous Results
^^Average
Complete
Response
rate
improvement
when
adding
an
NK-1
RA
to
a
5-HT3
RA
and
Dex
is
~15
-
20%
in
the delayed phase
* Poll-Bigelli; Cancer, 97:12, 3090, 2003
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*
87%
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,
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
19
45
65
67
0
10
20
30
40
50
60
70
80
90
100

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
20
SUSTOL Has the Potential to be the Next
Generation 5-HT3 Receptor Antagonist
5-HT3
RAs
1
st
generation
2
nd
generation
3
rd
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 will be based on completion of  new clinical trial

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
SUSTOL COMMERCIAL
OPPORTUNITY

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
22
U.S. CINV Market Dynamics
Source:  WK 07/2013
0
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
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

HEC Regimens Represent a Significant
Market Opportunity for SUSTOL
Table reflects IntrinsiQ
data
from
July
2012
–
June
2013.
HEC regimens account for ~20% (500K)
of palonosetron administrations
Of all HEC administrations, ~20% are given
without concomitant IV 5-HT3 –
inconsistent with clinical guidelines
HEC
MEC
LEC
Minimal
-
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
-
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
497,256
1,463,558
451,490
111,696
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
23
497,256
317,915
188,988

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
NEW PRODUCT INITIATIVE

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
Biochronomer™
Bupivacaine Has Superior
PK Profile in Dogs
*Projected from 7.5 mg/kg dose; EXPAREL data from Richard, et. al. 2012
Biochronomer Bupivacaine 15
mg/kg*
Bupivacaine Solution 9 mg/kg
Exparel 9 mg/kg
0
24
48
72
96
120
144
168
0
100
200
300
400
500
600
700
800
900
1000
Hours

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
26
Biochronomer™
Ropivacaine Has Superior PK
Profile in Dogs
*Dose adjusted to match bupivacaine; EXPAREL data from Richard, et. al. 2012
0.0
50.0
100.0
150.0
200.0
250.0
300.0
350.0
400.0
450.0
0
20
40
60
80
100
120
140
Hours
Biochronomer
Ropivacaine*
Exparel 9mg/kg

Evaluation of the Local Analgesic Effects of Two
BIOCHRONOMER Formulations in the Pig Model
for Post-Operative Pain
*p<0.05 using one-way ANOVA
**Ropivacaine solution results from Castle et al, 2013 EPJ; difference to placebo was not significant beyond 6 hours
Both
BIOCHRONOMER
formulations
provided
sustained
analgesic
effects
of
3-5
days
compared to control
BIOCHRONOMER products produced equal or greater analgesic effects for 24 hours than 1
mg/kg dose of morphine in this model**; activity equal or greater than that observed acutely
with ropivacaine solution was maintained with bupivacaine formulation for 72 hours
©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
27
0.0
10.0
20.0
30.0
40.0
50.0
60.0
0
1
3
5
24
48
72
96
120
Saline Control
Biochronomer
Bupivacaine
Biochronomer
Ropivacaine
Ropivacaine Solution

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
28
Ropivacaine Has Advantages Over
Bupivacaine
Bupivacaine
Ropivacaine
Efficacy
•
Both molecules have similar
efficacy, onset of action, and
analgesic potency
“Both of these products work well for
blocking pain…
the issue is that they
are
short
acting.”
–
Orthopedic
Surgeon
Safety
•
Lower CV and CNS toxicity
•
Overall better side-effect profile
“Safety is where ropivacaine has a
clear advantage.  It is widely known in
our institution that bupivacaine has
more
cardiovascular
toxicity.”
–
Anesthesiologist
MOA
•
Ropivacaine has been shown to
have shorter depth and duration
of motor block compared to
bupivacaine
Clinical
Flexibility
•
Considered more clinically
versatile by physicians
•
Approved for use in children
“For all these reasons, a long-acting
bupivacaine
is
a
‘hit’…
but
a
long-
acting ropivacaine would be a ‘home
run’.”
–
Orthopedic
Surgeon
1 Sources: 
Scott, et al. Anesth Analg 1989; 24: 514-518; 
Knudsen K, et al. Br J Anesth 1997 78; 507-514;  
Bertini, et al. Reg
Anesth
Pain
Med
1999;
4
Chelly
JE,
et
al.
J
Orthop
Trauma
2003;
Turner
G,
et
al.
Br
J
Anesth
1996;
76:606-610;
5
Writer
WDR,
et
al.
Br
J
Anaesth
1998;
81:
713-717.
6
McGlade,
et
al.
Anaesth
Intensive
Care
1998;26:515-520;
Arikan
OK,
et
al. J
Otaryngol Head Neck Surg 2008; 37(6): 836-43;
8
Ivani G, et al. Can J Anaesth 1999; 46(5): 467-469;
9
Pitimana-aree S, et al.
Reg
Anesth
Pain
Med
2005;
30(5):
446-51;
http://www.naropin-us.com/about_benefits.php
2 Source:  KOL interviews October 2013
Notes
1
1
2
3
7
5
KOL Feedback
2
“The goal is to achieve sensory
blockade without significant motor
blockade.  In this way, ropivacaine
seems
to
perform
better.”
–
Orthopedic Surgeon

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
29
Next Steps for Post-Operative Pain
Program
•
Finalize formulation optimization (dog PK provides a
good indicator of analgesic duration)
•
Conduct additional pain models
•
Conduct Short-term toxicology
•
Initiate Phase 1 in 1H2014
•
Assuming positive results from Phase 1, initiate
Phase 2 program in 2H2014

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
30
Summary –
Pipeline offers significant opportunity
for commercial value creation
•
Large, concentrated commercial
opportunity
•
Physicians view a non-inferior SUSTOL
profile as highly competitive with
palonosetron
–
5-7 day PK profile
–
Non-inferior to market leader palonosetron based
on large, head-to-head trial
–
Sustained efficacy over multiple cycles of
chemotherapy & efficacy in palonosetron failures
–
Favorable safety profile with clean QT results
•
With successful outcome in planned HEC
trial, a differentiated profile with delayed-
HEC indication would position SUSTOL
as the next generation IV 5-HT3
•
HEC regimens represent a significant
market opportunity
•
Large, growing market
•
High unmet need
•
3-5 day local anesthetic depot would offer
clinical differentiation
•
Clear value proposition given the costs of
post-operative pain
•
Rapid development and approval pathway
•
Potential opportunity for pain franchise
through line extensions
Chemotherapy-induced nausea
and vomiting
Post-Operative Pain

©
2013. Heron Therapeutics, Inc. All rights reserved. Confidential.
31
Financial Summary
Summary Statement of Operations
(In thousands, except per share data)
Nine Months Ended
September 30, 2013
Revenue
$             –
Operating expenses
40,626
Other income (expenses)
(614)
Net loss
$ (41,240)
Net
loss
per
share
$     (0.13)
Condensed Balance Sheet Data
(In thousands)
September 30, 2013
Cash and cash equivalents
$  22,597
Total assets
$  26,370
Total stockholders’
equity
$  20,872
1
Based on 306.1 million weighted average common shares outstanding for the period ended
September 30, 2013 (an additional 150 million issued for $60M raise in NOV2013).
$60M raised November 2013
1