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): September 26, 2007 (September 26, 2007)
Endo Pharmaceuticals Holdings Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-15989 | 13-4022871 | ||
|
(State or other jurisdiction
of incorporation) |
(Commission
File Number) |
(I.R.S. Employer
Identification No.) |
||
| 100 Endo Boulevard, Chadds Ford, PA | 19317 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrants telephone number, including area code (610) 558-9800
Not Applicable
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:
| ¨ | 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 7.01. | Regulation FD Disclosure. |
On September 26, 2007, the Registrant intends to make a slide presentation in New York, New York at the UBS Global Life Sciences Conference , a copy of which presentation is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
| (a) | Financial Statements of Business Acquired . |
Not applicable.
| (b) | Pro Forma Financial Information . |
Not applicable.
| (c) | Shell Company Transactions |
Not applicable.
| (d) | Exhibits . |
| Exhibit Number |
Description |
|
| 99.1 | Slide Presentation of Endo Pharmaceuticals Holdings Inc. dated September 26, 2007 |
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.
| ENDO PHARMACEUTICALS HOLDINGS INC. | ||||
|
(Registrant) |
||||
| By: | /s/ C AROLINE B. M ANOGUE | |||
| Name: | Caroline B. Manogue | |||
| Title: | Executive Vice President, Chief Legal Officer & Secretary | |||
Dated: September 26, 2007
INDEX TO EXHIBITS
| Exhibit Number |
Description |
|
| 99.1 | Slide Presentation of Endo Pharmaceuticals Holdings Inc. dated September 26, 2007 |
|
ENDO
PHARMACEUTICALS
UBS Global Life Sciences Conference
September 26, 2007
Exhibit 99.1
|
|
2
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Forward-Looking Statements
Except
for
the
historical
information
contained
herein,
this
presentation
contains
forward-looking
statements
within
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
Because
these
statements
involve
a
number
of
risks
and
uncertainties,
actual
future
results
may
differ
materially
from
those
expressed
or
implied
by
such
forward-looking
statements.
Factors
that
could
cause
or
contribute
to
such
differences
include,
but
are
not
limited
to,
the
difficulty
of
predicting
FDA
approvals,
results
of
clinical
trials
on
new
products,
acceptance
and
demand
for
new
pharmaceutical
products,
challenges
relating
to
intellectual
property
protection,
the
impact
of
competitive
products
and
pricing,
the
timely
development
and
launch
of
new
products,
a
determination
that
we
are
engaging
in
inappropriate
sales
or
marketing
activities,
including
promoting
the
"off-label"
use
of
our
products,
and
the
risk
factors
listed
from
time
to
time
in
the
Companys
SEC
reports,
including
the
Companys
Annual
Report
on
Form
10-K
for
the
fiscal
year
ended
December
31,
2006.
|
|
3
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Endo Pharmaceuticals
Leader in Pain Management
Market
Leadership in
Pain Management
Analgesics fourth-largest prescription drug market
in 2006 with $7.3 billion in reported sales
Opioids represented 80% of all analgesic Rxs
Proven
Commercial
Capability
Specialty and PCP sales and marketing teams
Sales force recently expanded by ~ 95 reps
Broad Pipeline in
Pain Management
Five products in mid-
to late-stage development
Strong Financial
Condition
No debt
Strong cash flow
|
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4
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Growth Strategy
Deepen and broaden penetration into the pain market
Target clinically innovative and differentiated products while
continuing to advance current development pipeline
Drive top-line growth by maximizing potential of key on-market
products and successfully launching FROVA in MM indication
Further diversify revenue base through product licensing and
acquisitions of other specialty-focused companies
Use balance sheet to maximize shareholder value
Continue to pursue selective development of generic products
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5
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
$1.75$1.80
Adjusted Diluted EPS
$90$110 million
OPANA
®
ER / OPANA
®
Net Sales
$685$710 million
LIDODERM
®
Net
Sales
$1.050$1.075 billion
Net Sales
2007 Guidance
|
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6
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
$399.0
$595.6
$615.1
$820.2
$909.7
$1,062.0
2002
2003
2004
2005
2006
2007*
Net Sales
Net Income
Consistent Financial Growth
$30.8
$69.8
$143.3
$202.3
$137.8
* Represents mid-point of company guidance; ** Includes $0.62 in one-time,
non-cash items
$1.03**
$1.52
$1.08
$0.53
$0.30
Diluted EPS
Millions, Except per Share
|
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7
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Sales Force Expansion
Specialty Sales Forces
0
50
100
150
200
Specialty I
Specialty II
Provides
double
coverage
to
broaden
reach and frequency among specialty MDs
Pain Management Specialists, Neurologists,
Oncologists, Physical Medicine and
Rehabilitation
Ensures high frequency on highest-decile
(e.g., 810) prescribers
~160
~160
~95
New
~65
Current
Provides Optimal Reach and Frequency to Promote Current Product Portfolio
Furthering already strong share of voice
in pain management
Total Sales Force = 690 Reps
23%
54%
23%
Specialty
II
Specialty
I
Primary
Care
Force
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8
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
LIDODERM
A True Success Story
Lidocaine 5% topical patch
Acts locally
no
therapeutically meaningful
blood levels
First FDA-approved drug for
treatment of pain of PHN
Provides analgesia (but no
anesthesia) directly to
affected nerves
Easy and convenient
to use
|
|
9
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
$ Millions
$178
$309
$419
$698
$567
$0
$200
$400
$600
$800
2003
2004
2005
2006
2007*
LIDODERM
Continuing Net Sales Growth
* Represents mid-point of company guidance
|
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10
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Protected by Five Orange Book-Listed
Patents Until 2015
Lidocaine-Containing Topical
Product That Does Not Numb the Skin
2012 Method of Use Patents
Submitted Citizen Petition Late
2006 and Amendments in Aug. 2007
LIDODERM
Protecting the Franchise
Cover use of lidocaine-
containing patch in indication
of PHN
Two method of use patents
expiring 2009
Two method of use patents
expiring 2012
Formulation patent expiring 2015
Unique attribute included in
labeling
Believe this would be requirement
for generic substitution
Requests FDA adhere to
existing clinical
bioequivalence standard
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11
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
OPANA
Franchise
|
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12
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
OPANA Update
Scripts (currently 6.5k per week) on track to meet
2007 guidance
Implemented aggressive managed-care strategy
to attain Tier II parity
Introduced OPANA ER Instant Savings
Card Program
Increased promotional and marketing activities
Redeployed Specialty Force II
Launched new promotional materials
Full schedule of peer-to-peer speaker programs
Major presence at APS and at upcoming medical
conferences with clinical data presentations
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13
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
OPANA ER vs. Competitive Launches (Retail and Mail Order TRxs)
OPANA ER TRx Launch Comparison
Notes: Data includes only retail and mail order; OPANA ER data through August 2007
Sources: Data for Duragesic and Oxycontin were pulled from IMS Health's New
Product Spectra; Data for OPANA
ER, Avinza and Palladone were pulled from WK
Health's Phast Prescription Audit
0
10,000
20,000
30,000
40,000
50,000
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Months Since Launch
OPANA ER
Avinza
Duragesic
OxyContin
Palladone
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Development Pipeline
Phase I
Phase II
Phase III
Filed
Pre-clinical
Product
(1) Licensed marketing rights; (2) Licensed marketing and development
rights
FROVA
®
(1)
(Menstrual Migraine)
RAPINYL
TM (2)
(
Breakthrough Cancer Pain
)
EN 3285
(Oral Rinse for Oral Mucositis)
Undisclosed
Ketoprofen Patch
(2)
(
Topical
-
Soft
Tissue
Injuries
)
Sufentanil Patch
(2)
(Transdermal -
Chronic Pain)
|
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15
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
FROVA
®
MM Prophylaxis:
Exciting Near-Term Opportunity
FROVA taken for six days, starting two days prior to onset of
expected MM headache
Primary efficacy endpoint: reduction in incidence of MM
p <0.0001 to p < 0.01 (vs. placebo)
Secondary endpoints
reduction in severity and duration of MM
headache
also achieved
Pivotal
Efficacy
Studies
PDUFA Date
Extended beyond 8/19/07
New action date 9/30/07; no additional information requested by
FDA
Substantial
Clinical Data
Package
Submitted
Includes two statistically significant Phase III, double-blind,
placebo-controlled studies; long-term open-label safety and
tolerance study
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16
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
FROVA
Longest Half-Life,
Lowest Migraine Recurrence Rate
Zolmitriptan 2.5mg
Eletriptan 80mg
Almotriptan 12.5mg
Naratriptan 2.5mg
Frova 2.5mg
Sumatriptan 6mg (sc)
Rizatriptan 10mg
Sumatriptan 100mg
0%
10%
20%
30%
40%
50%
0
5
10
15
20
25
30
Plasma Half Life (h)
Frova 2.5mg
|
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17
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
FROVA
®
MM Market Development
Raise Awareness
of FROVA MM
(Branded)
Raise Awareness
of MM
(Unbranded)
Full FROVA MM
Promotion
Pre-Approval
Pre-Launch
Launch
(January 2008)
|
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18
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
RAPINYL
TM
Profile
Oral, fast-dissolving sublingual fentanyl tablet
Usage
Intended for the treatment of breakthrough cancer pain
Expected to compete with Actiq and Fentora
Anticipated
Benefits
Fast onset of action
Enhanced absorption characteristics
Added patient convenience
Trials
Phase III trials ongoing
|
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19
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Topical Ketoprofen Patch
Usage
For localized treatment of acute pain from soft-tissue
injuries such as tendonitis/bursitis, joint sprains or strains
Availability
Ketoprofen (NSAID) currently available in U.S. as
oral only
Market
Would compete in ~$2.5 billion soft-tissue injury market
primarily consisting of NSAIDs and COX-IIs
Anticipated
Benefits
Bypassing bloodstream to minimize GI and cardiovascular
side effects
Local, targeted pain control
Convenience of once-daily dosing
|
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20
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Ketoprofen
Patch
Clinical Trial Update
Two Phase III Trials Did Not Meet Primary Endpoint
Ankle sprains and strains
Tendonitis/bursitis of shoulder, elbow or knee
Analyzing Data to Determine Next Course of Action
Outcome may have been influenced by several factors, including
severity of pain on entry and use of ibuprofen as rescue medication
One Phase III trial currently running in tendonitis or bursitis of the
shoulder, elbow or knee
One long-term safety study ongoing in osteoarthritis flare of the
knee
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21
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
EN
3285
About 400,000 patients per year in U.S. develop OM
Only current FDA-approved treatment is IV infusion
Market
Expect to initiate next clinical trial by year-end
Trials
EN 3285
Key product obtained in RxKinetix acquisition
Patent-protected oral rinse formulated using proprietary
ProGelz
®
delivery platform for prevention of oral mucositis
(OM)
Ease of use for patients
No systemic side effects
Anticipated
Benefits
|
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22
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Transdermal Sufentanil Patch
Profile
Intended for moderate-to-severe chronic pain
Next-generation extended-release opioid
patch
Anticipated
Benefits
Convenience/compliance of seven-day dosing
vs. three-day dosing
Smaller patch
20% the size of Duragesic
Trials
Phase I product characterization ongoing
Phase II trial now underway
Designed to evaluate conversion from oral opioids
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23
Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Summary
Market leader in pain management
Well-developed commercial capability
Very broad and deep pipeline
Strong financial condition
Clear strategy for sustainable growth
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ENDO PHARMACEUTICALS
NASDAQ: ENDP
|