Filed On 9/28/05 3:57pm ET ˇ SEC File 0-27354 ˇ Accession Number 950116-5-3070
As Of Filer Filing As/For/On Docs:Pgs Issuer Agent
9/28/05 Impax Laboratories Inc 8-K/A{7,9} 9/26/05 2:28 950116
Amendment to Current Report ˇ Form 8-K
Filing Table of Contents
Document/Exhibit Description Pages Size
1: 8-K/A Amendment to Current Report 3 12K
2: EX-99 Exhibit 99.1 Presentation 25 41K
EX-99 ˇ Exhibit 99.1 Presentation
IMPAX Laboratories, Inc.
September 2005 v1 IMPAX Laboratories, Inc. 1
IMPAX LABORATORIES, INC. (OTC: IPXL)
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995: To the extent any statements made in this presentation contain information
that is not historical, these statements are forward-looking in nature and
express the beliefs and expectations of management. In particular, the
forward-looking statements include statements about IMPAX's estimated timelines
and new application filing goals. Such statements are based on current
expectations and involve a number of known and unknown risks and uncertainties
that could cause Impax's future results, performance or achievements to differ
significantly from the results, performance or achievements expressed or implied
by such forward-looking statements. Such risks and uncertainties include, but
are not limited to, possible adverse effects resulting from the delisting of
Impax's stock, Impax's delay in filing its 2004 Form 10-K and its Form 10-Q's
for the first two quarters of 2005, Impax's ability to obtain sufficient capital
to fund its operations, the difficulty of predicting FDA filings and approvals,
consumer acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, Impax's ability to successfully develop and
commercialize pharmaceutical products, Impax's reliance on key strategic
alliances, the uncertainty of patent litigation, the availability of raw
materials, the regulatory environment, dependence on patent and other protection
for innovative products, exposure to product liability claims, fluctuations in
operating results and other risks detailed from time to time in Impax's filings
with the Securities and Exchange Commission. Forward-looking statements speak
only as to the date on which they are made, and Impax undertakes no obligation
to update publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments occur or
otherwise.
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NOTE: ALL SALES DATA REFERENCED HEREIN IS NDCHEALTH, CURRENT 12 MONTHS ENDING
JULY 31, 2005, EXCEPT SALES DATA FOR CARPROFEN, A VETERINARY PRODUCT, WHICH ARE
12 MONTHS ENDING DECEMBER 31, 2004 FROM MARKET DYNAMICS.
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Trademarks referenced herein are the property of their respective owners.
September 2005 v1 IMPAX Laboratories, Inc. (C)2005 IMPAX Laboratories, Inc.
2
COMPANY OVERVIEW
o Technology based specialty pharmaceutical company
o Applying oral, drug delivery technology and formulation expertise to the
development of generic and branded pharmaceutical products
o Experienced senior management team
o Strong product portfolio
o Strong strategic partners
o Brand strategy offers long-term growth opportunities
September 2005 v1 IMPAX Laboratories, Inc. 3
PRODUCT PORTFOLIO
o Approximately 93 generic products approved, pending or under development -
targeting more than $27.5 billion in US product sales
|X| 28 Approved applications
|X| 14 Applications pending at FDA
o 5 ANDAs with Tentative Approval
|X| Approximately 51 more under development
o Additional products and/or strengths
o Additionally, 1 NDA for a brand product is pending with 3 more under active
development
September 2005 v1 IMPAX Laboratories, Inc. 4
R&D HIGHLIGHTS
o 2004 - Received 11 approvals from FDA
|X| Two Tentative Approvals - generic versions of:
Allegra-D
Tricor Tablets
|X| Nine Final Approvals - generic versions of:
Wellbutrin SR 100,150 mg Claritin-D 24-hr
Declomycin Sinemet CR
Zyban Proamatine
Glucophage XR 500mg OxyContin 80 mg
Wellbutrin SR 200 mg
September 2005 v1 IMPAX Laboratories, Inc. 5
R&D HIGHLIGHTS
o 2005 YTD - Received 5 approvals from FDA
|X| Tentative Approval for a generic version of:
Ditropan XL
|X| Final approvals for generic versions of:
Dantrium
Agrylin
Rimadyl (a veterinary product)
Glucophage XR 750 mg
September 2005 v1 IMPAX Laboratories, Inc. 6
COMMERCIAL HIGHLIGHTS
o 2004
|X| Launched 8 new products - generic versions of:
Claritin Reditabs Wellbutrin SR Tablets (100,150)
Declomycin Tablets Sinemet CR Tablets
Zyban Tablets Prilosec Capsules
Proamatine Tablets Wellbutrin SR Tablets (200)
o 2005
|X| Launched 5 new products - generic versions of:
Claritin-D 24 hour Dantrium Capsules
OxyContin 80mg CR Tablets Agrylin Capsules
Rimadyl Caplets (a veterinary product)
September 2005 v1 IMPAX Laboratories, Inc. 7
DRUG DELIVERY CAPABILITIES
o Multiple delivery vehicles
o Applying new and existing drug delivery technologies to create new product
opportunities
(18 approved ANDAs utilize our drug delivery technologies)
o Developing and patenting new concepts and oral, controlled release
technologies
o Over 110 employees in our R&D effort
September 2005 v1 IMPAX Laboratories, Inc. 8
DEVELOPMENT STRATEGY
o Target limited competition environment
|X| Generic
o Controlled Release- large, rapidly growing market
o Specialty- technically challenging projects, barriers to entry, or
other selected market opportunities
|X| Brand
o Targeting drugs used in treating CNS disorders
o Focusing on improved versions of marketed compounds
|X| Lower cost - much smaller R&D investment compared to NCEs
|X| Lower risk of development - compounds previously shown to be safe
and effective
September 2005 v1 IMPAX Laboratories, Inc. 9
DEVELOPMENT STRATEGY
o Outsourced Development
|X| Selected Generic Projects
o 20 development projects outsourced
o Utilizing 6 off-shore companies
|X| Provides
o Lower cost of development
o Increased development capacity
September 2005 v1 IMPAX Laboratories, Inc. 10
GENERIC PROJECTS
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Current Status
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Group Specialty Controlled Release Total
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Category Qty Market* Qty Market* Qty Market*
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Pending at FDA 6 $463 8 $5,175 14 $5,638
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Under Development 28 $2,927 23 $15,677 51 $18,604
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Total 34 $3,390 31 $20,852 65 $24,242
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*US Market size, millions of US$
September 2005 v1 IMPAX Laboratories, Inc. 11
GENERIC PROJECTS
Paragraph IV Filing Summary (21 total)
ˇ Enlarge/Download Table
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IMPAX PROJECT GENERIC OF* EST. FILING INITIAL
ORDER** FILING
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Omeprazole 10,20,40mg DR Prilosec (AZN) 5th of 10 total 4Q99
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Bupropion 100,150mg ER Wellbutrin SR (GSK) 3rd of 5 total 2Q00
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Bupropion 150mg ER Zyban (GSK) 2nd of 4 total 2Q00
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Fenofibrate 67,134,200mg Tricor Capsule (ABT) 2nd of 2 total 2Q00
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Loratadine & PSE 10/240mg ER Claritin-D 24 hr (SGP) 2nd of 3 total 3Q00
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Loratadine 10mg ODT Claritin Reditab (SGP) 3rd of 3 total 4Q00
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Loratadine & PSE 5/120mg ER Claritin-D 12 hr (SGP) 1st of 2 total 4Q00
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Metformin 500mg ER Glucophage XR (BMS) 2nd of 11 total 3Q01(1)
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Fexofenadine & PSE 60/120mg ER Allegra-D (AVE) 2nd of 4 total 4Q01
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Oxycodone 80mg ER OxyContin (PUR) 3rd of 3 total 4Q01
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Oxycodone 10,20&40mg ER OxyContin (PUR) 3rd of 3 total 2Q02
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*Trademarks referenced are the property of their respective owners.
**Estimation based on publicly available data.
Note (1)--Paragraph IV certification and notice filed 4Q02.
September 2005 v1 IMPAX Laboratories, Inc. 12
GENERIC PROJECTS
Paragraph IV Filing Summary
ˇ Enlarge/Download Table
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IMPAX PROJECT GENERIC OF* EST. FILING INITIAL
ORDER** FILING
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Fenofibrate 54,160mg Tricor Tablet (ABT) 2nd of 4 total 3Q02
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Methylphenidate 18,27,36&54mg ER Concerta (Alza/JNJ) 1st of 2 total 3Q02(2)
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Carbidopa/Levodopa ER Sinemet CR (BMS) 2nd of 4 total 4Q02
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Carprofen 25,75 &100mg (Vet) Rimadyl (Pfizer) 1st 4Q02
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Bupropion 200mg ER Wellbutrin SR (GSK) 1st of 2 total 1Q03
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Oxybutynin 5,10,15mg ER Ditropan XL (Alza/JNJ) 2nd of 2 total(3) 2Q03
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Amphetamine 5,10,15,20,25&30mg ER Adderall XR (Shire) 2nd of 4 total 3Q03
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Metformin 750mg ER Glucophage XR (BMS) 5th of 8 total 4Q03
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Bupropion 150&300mg ER Wellbutrin XL (GSK) 3rd of 3 total 4Q04
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Undisclosed 4Q04(2)
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*Trademarks referenced are the property of their respective owners.
**Estimation based on publicly available data.
Note (2)--Paragraph IV certification and notice filed 3Q05.
Note (3)--May be first to have filed on 15 mg strength.
September 2005 v1 IMPAX Laboratories, Inc. 13
GENERIC PROJECTS
Paragraph IV Litigation Status Summary (21 total filed)
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Litigation Resolved or Not Sued (12 projects)
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Bupropion 100,150mg ER (W) Carbidopa/Levodopa ER
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Bupropion 150mg ER (Z) Metformin 500mg ER
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Fenofibrate 67,134,200mg Caps Carprofen 25,75,100mg
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Loratadine & PSE 10/240mg ER 24hr Bupropion 200mg ER
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Loratadine 10mg OD Metformin 750mg ER
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Loratadine & PSE 5/120mg ER 12hr Fenofibrate 54 &160mg Tabs
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September 2005 v1 IMPAX Laboratories, Inc. 14
GENERIC PROJECTS
Paragraph IV Litigation Status Summary (21 total filed)
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Project Litigation Status
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Omeprazole 10,20 &40mg DR Discovery extended. No trial date set.
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Fexofenadine & PSE ER Estimated trial, mid-2006.
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Oxycodone 80mg ER Judgment entered. Purdue petitioning
Oxycodone 10,20 &40mg ER for re-hearing en banc on decision v.
Endo.
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Oxybutynin 5,10 &15mg ER Trial scheduled February 2006.
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S.E. Amphetamine ER Trial scheduled February 2006.
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Bupropion 150 &300mg ER (XL) Recently sued. No trial scheduled.
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Methylphenidate ER Recently filed as Paragraph IV.
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Undisclosed Recently filed as Paragraph IV.
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September 2005 v1 IMPAX Laboratories, Inc. 15
COMMERCIAL STRATEGY
Strategic Alliance for Generic Projects
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Teva (Rx Partners)
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---------------------------------
LAUNCHED
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Omeprazole 10,20 mg DR
Bupropion 100,150 mg ER (W)
o Signed June 2001 Bupropion 150 mg ER (Z)
o First product shipped 1Q 2004 Loratadine OD
o 12 Rx products Loratadine/PSE ER, 12 hr
|X| 11 Filed to date Loratadine/PSE ER, 24 hr
|X| 11 disclosed ------------------ Metformin 500 mg ER
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[NOT YET LAUNCHED]
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Omeprazole 40 mg DR
Methylphenidate 18,27,36,54 mg ER
Fexofenadine/PSE 60/120 mg ER
Oxybutynin 5,10,15 mg ER
Bupropion 150, 300 mg ER (XL)
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September 2005 v1 IMPAX Laboratories, Inc. 16
COMMERCIAL STRATEGY
Strategic Alliances for Generic Projects
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OVER THE COUNTER (OTC)
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ˇ Enlarge/Download Table
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PARTNER DATE LORATADINE STATUS
PRODUCTS
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Novartis Dec 2001 ODT (Ped) Launched 2Q04 as Triaminic
brand. Terminated 2Q05
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Wyeth Jun 2002 D-12 Launched 2Q03 as
Alavert D12
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Schering Jun 2002 D-12 Launched 1Q03 as
Claritin D12
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Leiner Jun/Jul 2004 ODT & D-24 Launched ODT 4Q04
Launched D-24 1Q05
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September 2005 v1 IMPAX Laboratories, Inc. 17
BRAND PROJECTS
o Targeting improved versions of existing chemical entities
|X| Reduced risk and expense associated with development as compared to NCE
development.
|X| Reduced time of development as compared to NCE development
o Utilize development and drug delivery expertise
|X| Improve patient compliance and outcomes
September 2005 v1 IMPAX Laboratories, Inc. 18
BRAND PROJECTS
o Focus on Central Nervous System (CNS) drugs
|X| Rapidly growing therapeutic area
|X| Focus on CNS disease states, including movement disorders such as
Parkinson's disease.
|X| These movement disorders are frequently treated by the approximately
8,300 practicing neurologists, of which about 3,500 write the majority
of prescriptions. This group can be addressed by a small, specialized
sales force.
September 2005 v1 IMPAX Laboratories, Inc. 19
BRAND PROJECTS
o Despite being the standard for treating Parkinson's Disease, levodopa
therapy has several unmet needs:
|X| Motor fluctuation and dyskinesias
|X| Pill burden
|X| Delayed or unpredictable "on"
|X| True delivery of continuous dopaminergic stimulation
o VADOVA(TM) (carbidopa-levodopa) is uniquely formulated to meet some of these
unmet needs including reduction in pill burden.
September 2005 v1 IMPAX Laboratories, Inc. 20
Brand Projects
o The effective date of acceptance of the VADOVA NDA by FDA was May 3rd.
|X| The application contained a Paragraph III certification which prevents
any approval from becoming effective prior to June 16, 2006.
o US Patent applications filed.
September 2005 v1 IMPAX Laboratories, Inc. 21
BRAND PROJECTS
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2003 2004 2005 2006 2007
IPX054 - VADOVATM (carbidopa-levodopa)
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Formulation Pivotal Studies/ Development NDA Review
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o IND Filed o NDA Filed -505(b)(2)
IPX056
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Formulation Development Clinical
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o IND Filed
September 2005 v1 IMPAX Laboratories, Inc. 22
SIGNIFICANT MILESTONES
ˇ Enlarge/Download Table
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Milestone 2000 2001 2002 2003 2004 2005
(YTD)
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Applications Filed 8 8 8 8 6 3
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o PPG IV filings 7 2 5 4 1 2*
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o IND filings 0 0 0 2 1 0
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o NDA filings 0 0 0 0 0 1
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Approvals (Total) 2 1 8 9 11 5
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o Tentative approval 0 0 5 2 2 1
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Teva, Wyeth, Andrx/
Strategic Alliances -- Novartis Schering Teva Leiner Vedco
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*Includes amendments to previously filed applications--not included in YTD
applications filed
FILING GOAL 2005: 8 NEW APPLICATIONS
September 2005 v1 IMPAX Laboratories, Inc. 23
HIGHLIGHTS
o Experienced management with strong industry knowledge and technical
expertise
o Broad base of drug delivery technology, formulation and development
expertise
o Strong product portfolio
o Strong strategic partners -
Teva, Wyeth, Schering and Leiner
o Branded product strategy offers a long-term growth opportunity
September 2005 v1 IMPAX Laboratories, Inc. 24
Thank you for your interest in
IMPAX Laboratories, Inc
September 2005 v1 IMPAX Laboratories, Inc. 25
Dates Referenced Herein and Documents Incorporated By Reference
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