EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm
*Copyright©2008, SCOLR Pharma, Inc.
1
*January 2008
SCOLR Pharma, Inc.
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Self Correcting Oral Linear Release -
 Enabling Technologies for Oral Medications
SCOLR Pharma
CDT  is a registered trademark of SCOLR Pharma, Inc.
SCOLR & CDT logo and design are trademarks of SCOLR Pharma, Inc.
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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 Forward-Looking Statements
§ This presentation contains forward-looking statements within the
 meaning of the Private Securities Litigation Reform Act of 1995
 that involve significant risks and uncertainties. These statements
 represent management’s present expectations of future events
 and are subject to a number of important factors that could cause
 actual results to differ materially from those described in the
 forward-looking statements.
§ Please refer to the risk factors and other cautionary language
 includ-ed in our reports and other filings with the Securities and
 Exchange Commission and available on our website.
§ We assume no obligation to update these forward-looking
 statements.
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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*Kalorama Information 2007 (Cited by In-Pharma
Technologist.com 1-17-2007
SCOLR Pharma: A Differentiated Oral Drug Delivery Company
§ Proprietary, validated technology - CDT® platform
 § Greater extended-release flexibility
 § Enhanced bioavailability
 § Less complex/cost-effective formulations
§ Develops, licenses and commercializes novel products with
 significant market potential
 § Distributed risk pipeline of internal and partnered targets with
 significant market potential
 § Significant partnerships include
 § Dr. Reddy’s
 § BioCryst Pharmaceuticals
 § Perrigo
 § Market is forecast to increase 48% to reach $52.1 billion in
 revenues by 2010*
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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CDT® - A Better Oral Drug Delivery Alternative
§ New generation of less complex, cost-effective tablet/capsule
 formulations
§ Uses standard GRAS ingredients and equipment
§ Based on a portfolio of 5 recently issued and pending patents for
 § Robust, predictable and programmable extended-release
 § Improved solubility/absorption/permeability/consistency
 § Gastro-intestinal (GI) stable formulations
§ Applicable to broad range of drug types and classes and consumer
 products
§ Provides novel formulations with robust, predictable and
 programmable drug release
§ 18 validating clinical studies, n > 550, as of 01/08
§ Successful commercialization/scale-up > 100 million tablets shipped
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Important Current Collaborations Expand Pipeline Potential
§ Dr. Reddy’s Laboratory (DRL) - Collaboration & License Agreement
 § Develop/commercialize CDT-based cardiopulmonary drug
§ BioCryst Pharmaceuticals - Research Collaboration
 § Develop an oral formulation of Peramivir, an injectible drug
 currently under development by BioCryst for the treatment of
 seasonal and life threatening influenza, including the avian flu
§ Perrigo Company- Development and Distribution Alliance
 § 5 CDT-based nutraceutical products currently on the market
 § Largest provider of store brand nutritional and over-the-counter
 (OTC) pharmaceutical products in the U.S.
§ Global Consumer Products Company - Collaboration Extended 12/07
 § Novel application of SCOLR technology for existing global
 consumer product
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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SCOLR
(CDT®)
Alza
(OROS®)
Biovail
(FUZE®)
Flamel
(Micropump®)
Pacira
Former Skyepharma
(GeoMatrix®)
Labopharm
(Contramid®)
Wide Range of
Drugs Tested
Yes
(Over 40)
Yes
No
Yes
Yes
No
Mode of Action
Hydrophilic
matrix,
swellable
polymer
matrix
Reservoir
device, osmotic
pump
Multi-particulate,
erosion,
dissolution
Multi-
particulate,
erosion,
dissolution
Multi-layered
tablet,
hydrophilic
matrix,
swellable
polymer matrix
Hydrophilic
matrix,
swellable
polymer matrix
Estimated
Manufacturing
Steps
2-3
18 or more
36 or more
Numerous for
micro-bead
12 or more
Numerous for
polymer
3-4, tablet
Limitations*
*As compared
with SCOLR’s
CDT Matrix
Technology
 
Complex,
payload
restrictions,
fragile, short
exclusivity
Multiple
manufacturing
steps, complex
processes
Multiple
manufacturing
steps, complex
processes
Specialized
manufacturing
equipment,
complex
Special
engineered
polymer, limited
source,
availability and
application
CDT Difference: Broadly Applicable, Flexible, Cost-Effective Sustained Release
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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SCOLR
(CDT®)
Elan
(Nanocrystal)
Nano/Micron
Milling
Cydex
(Inclusion
complex)
Altair
(Ti Nanosphere)
Solid
Dispersion
Process
Description
Hydrophilic
matrix, swellable
polymer matrix
Super critical
fluid process, re-
formation of
nanometer sized
drug crystals
Mill the drug
down to the sub-
micron size in
order to increase
surface area for
enhanced
solubility
Cyclodextrin
inclusion
complex.
“Mask” the
insoluble drug by
incorporating
into a soluble
sugar ring
Engineered
nano sphere.
Drug is applied
onto the surface,
or inside
Suspend drug
into inert/soluble
matrix in order to
prevent
agglomeration
during hydration
Estimated
Level of
Complexity
Low
High
High
High
High
Medium
Comments
Simple
granulation,
can be
incorporated
into tablets or
capsules
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Used alone or in
combination.
Often needed to
prevent
agglomeration
CDT Difference: Less Complex Solubility/Absorption Enhancement
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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 § Time to market
 § Drug suitability
 § Regulatory pathway
 § Improvements to existing
 therapy
 § Novelty & patent protection
Building Pipeline Through Disciplined Target
Selection
§ Robust Proprietary Database
§ Rigorous Selection Criteria
 § Market size
 § Exclusivity status, patent
 expiration
 § Partnership interest
 § Competition
 § Cost to market
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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CDT® OTC Targets
Indication
Est.
Launch
Status
Comments
Pre-
clinical
Phase
I/II
Phase
III
Sub-
mission
Ibuprofen - 12 hr.
Analgesia
Late
2009
     
2008
Pivotal - Phase III Trials
started Q-4, 2007
Pseudoephedrine - 12 hr.
Cough/Cold
Late
2009
     
2008
ANDA submission 2008
CDT® Rx Targets
             
Raloxifene - IR
Osteoporosis
TBD
       
Two pilot trials completed, Pivotal
trial requirements being evaluated
Ondansetron - 24 hr.
Chemo-
induced
nausea,
vomiting
TBD
       
Two pilot trials completed, Pivotal
trial requirements being evaluated
Risperidone - 24 hr.
Schizophrenia,
bipolar mania
TBD
       
Formulation work completed, Pilot
trials to be scheduled
Rivastigmine - 24 hr.
Alzheimer’s
Disease
TBD
       
Formulation work completed, Pilot
trials to be scheduled
Peramivir (BioCryst) - IR
Influenza
TBD
       
Formulation work in progress,
Preclinical evaluation in progress
Cardiopulmonary Drug
(Dr. Reddy’s)
             
Confidential
Growing OTC & Rx Pipeline with Market > $15 B
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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CDT® Dietary
Products
Indication
Est.
Launch
Formulation
Scale Up
Marketed
Comments
Glucosamine -
Chondroitin
Nutritional
Supplement
Q-2,
2006
     
Introduced Q-1, 2006
Glucosamine -
Chondroitin - MSM
Nutritional
Supplement
Q-4,
2006
     
Introduced Q-4, 2006
Glucosamine
Complex
Nutritional
Supplement
Q-4,
2006
     
Introduced Q-4, 2006
Glucosamine -
Chondroitin (Low
Sodium)
Nutritional
Supplement
Q-4,
2006
     
Introduced Q-4, 2006
Calcium w/ Vitamin D
Nutritional
Supplement
Q-2,
2007
     
Introduced Q-2, 2007
Other(s)
Nutritional
Supplement(s)
TBD
     
Confidential
Consumer Products
           
Undisclosed
Application
Confidential
TBD
     
Formulation development and
evaluation in progress
Confidential
Consumer Product Pipeline with Markets > $ 2 B
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Innovation: Better Than Brand!
5 Current Extended-Release Products …
§ Sodium Free, Glucosamine Sulfate;
 Glucosamine/Chondroitin & Glucosamine
 Chondroitin/MSM, Calcium w/ Vit. D:
 § Convenient - once/day
 § Active ingredients delivered over extended
 time period
 § Exclusive and patented
CDT-Nutritional Products With Perrigo
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Platform Consists of Recently Issued CDT® Patents
 § 2000 / US Patent # 6,090,411
 § “Salt Patent” allows for simple two step processing. Uses ionic
 interactions to correct for the limitations in other first generation
 matrix based systems
 § 2002 / US Patent # 6,337,091
 § Dual Polymer Patent” allows for simple production of tablets or
 capsules. Uses ionic and anionic polymers to correct for limitations
 in other biphasic/triphasic systems
 § 2003/2005/2007 US Patents # 6,517,868, # 6,936,275 and #
 7,229,642
 § “Amino Acids Patent” allows for simple production of tablets. Uses
 hydrophobic/polar interactions to facilitate solubility and potentially
 permeability
 § 2004/ beyond
 § Additional patent filings and continuations in process
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Lead Products
Application
Potential Advantages
Status
Current
Market
Estimate
(1)
CDT - 12 hr
Ibuprofen
OTC Analgesic
- 1st extended-release OTC
 ibuprofen
- 1 tablet vs. 3 every 12 hrs.
- Lower cost
- Patent protected
- Reacquired rights
- Multiple pilot trials
 completed
- Pivotal trials started Q4, 07
- NDA 505(B)2 planned 2008
$ 8.0 billion
(Global OTC
 analgesic)
CDT - 12 hr
Pseudoephedrine
OTC
Decongestant
- 1/3rd size of current OTC
 products
- Lower cost
- Patent protected
- ANDA trials completed,
 Q-2, 05
- ANDA submission planned 2008
$ 1.0 billion
(combined
global market)
Notes: (1) Market Data Sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR
 estimates.
Current OTC Development Targets
$9 billion Combined Market
(1)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Wyeth Termination Expands Opportunities
for First OTC Extended-Release Ibuprofen
Background
§ Global Licensing Agreement signed December 2005
§ Focused on OTC formulation transfer, scale-up, and validation
§ Wyeth terminated agreement in March 2007 under “no fault”
 provision
Current Status
§ SCOLR advancing commercialization program, Phase III pivotal
 trials initiated, 4Q 2007
§ SCOLR pursuing license to “branded” partners
§ SCOLR evaluating stand-alone market option
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Rx products for size reference
only
6 tabs/24 hr
6 tabs/24 hr
2 tabs/24 hr
Not Available in US
SCOLR CDT-Ibuprofen: First 12-hour Extended-Release
Tablets
CDT tablets compared to existing immediate-release tablets
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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as reported by Biovail
Contract Research
12hr CDT-Ibuprofen Release Profile Equals 3 IR Tablets
§ Clinical trial - Scaled final product formulation
 § “Highlighted” formulation with improved PK attributes manufactured at suitable commercial scale.
 (Coated tablets)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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N=26 subjects
as reported by
AAIPharma
CDT-Pseudoephedrine: Offers Same Drug Load with
Smaller, More Cost-Effective Tablets
Initial CDT-Pseudoephedrine testing bioequivalent to Sudafed® 12 hour (Reference
 Product)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Lead Products
Application
Potential Advantages
Status
Current
Market
Estimate
(1)
CDT - IR Raloxifene
Rx Osteoporosis
- Less drug for similar
 results(2)
- Simplified manufacturing
- Lower cost
- Patent protected
- 2 Human studies completed
- Results positive
- Reviewing clinical
 requirements for regulatory
 approval with FDA
$ 1.0 billion
 (Global)
CDT - ER
Ondansetron
Rx Anti-Nausea
- Improved absorption(2)
- 1 tablet vs. 3 every 24 hrs.
- Simplified manufacturing
- Lower cost
- Patent Protected
- 2 Human studies completed
- Results Positive
- Reviewing clinical
 requirements for regulatory
 approval with FDA
$ 1.6 billion
 (Global)
BioCryst
Collaboration:
CDT - Neuraminidase
Inhibitor (Peramivir)
Rx Flu Treatment
-Convert current injectible
 product to oral tablet
- Ease of administration
- Consumer compliance
- Broad application
-Initial development
 announced winter 2006.
-Oral formulation work
 ongoing
> $1.0 billion
 (Global)
DRL Collaboration:
Undisclosed CDT-
based Rx target
Cardiopulomary
- Lower cost
- Patent protected
- Other non-disclosed
-Initial development
 announced October 2007.
-Oral formulation work
 ongoing
-
Undisclosed
Notes: (1) Market data sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR estimates.
 (2) Based on 2004 animal study findings and initial 2005 clinical results
Current Rx Development Targets
$ 3.6 billion Combined Market
(1)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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CDT Enhances Bioavailability
N=34 subjects
as reported by Biovail
Contract Research
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Once-Daily CDT-Ondansetron Results Comparable to
Multiple Dose Industry Standard
TIME ABOVE MINIMUM PLASMA CONCENTRATION
as reported by Biovail
Contract Research
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Lead Products
Application
Potential Advantages
Status
Current Market
Estimate
(1)
CDT - 24 hr
Risperidone
Rx schizophrenia and
bipolar mania
management
- 1 tablet vs. 2 every 24 hrs.
- Simplified manufacturing
- Lower cost
- Patent protected
- Formulation work
 initiated Q-4 ’06
- Pilot clinical trials to be
 scheduled
$ 1.8 billion
 (Global)
CDT - 24 hr
Rivastigmine
Rx Alzheimer’s Disease
-  1 tablet vs. 2 every 24 hrs.
- Improved convenience
- Patent protected
- Formulation work
 initiated Q-4 ’06
- Pilot clinical trials to be
 scheduled
$ 0.5 billion
 (Global)
       
Notes: (1) Market data sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR
 estimates.
New Rx Development Targets
$2.3 billion Combined Market
(1)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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2007/08 Strategic Growth Initiatives
§ Initiate pivotal trials for CDT-Ibuprofen, 4Q - 2007
§ Submit ANDA for 12 hr CDT-Pseudoephedrine, 2008
§ Expand “All Day” product suite with Perrigo, 2008
§ Advance existing portfolio targets
§ Apply CDT platform to new targets
§ Enter new alliance and partnership agreements
§ Build intellectual property estate/portfolio
§ Raise additional capital to advance and expand
 pipeline
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Management
§ Daniel O. Wilds, President, CEO and Director, appointed 2003
 § Previously, Chairman, President and CEO of Northwest Biotherapeutics,
 President and CEO of Shiloov Biotechnologies (USA), Adeza Biomedical and
 Medisense, President of Baxter’s Chemotherapy Service, and President and
 COO of Travenol-Genetech, a joint venture between Baxter International and
 Genentech
§ Alan M. Mitchel, Sr. VP Business & Legal Affairs and CLO, appointed
 2005
 § Extensive legal, business and corporate finance experience most recently at
 Gray Cary, Former outside counsel for SCOLR
§ Stephen J. Turner, VP Research and Development, CTO, appointed 2003
 § Employed in positions of increasing responsibility at SCOLR since 1999. Built
 SCOLR’s R&D and Information Technology Functions
§ Richard M. Levy, CPA, VP of Finance, CFO, appointed 2006
 § Previously Corporate Controller for Safeco Insurance, CFO for the Specialty
 Finance Segment and Corporate Controller for Washington Mutual Bank,
 Senior Vice President and Controller of Texas operations at Bank of America
§ Tanya Raco, Assoc. VP of Regulatory and Quality Affairs, appointed 2006
 § Employed in positions of increasing responsibility at SCOLR since 1997. Built
 SCOLR’s Regulatory and Quality Assurance Functions
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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Balance Sheet and Capital Structure
Balance Sheet Data       
September 30, 2007   (In Thousands)
Cash and Investments      $11,400
Working Capital                               $10,500
Total Assets       $13,200
Total Debt       $210
        (In Millions)
Common Shares Outstanding    38.2
Fully - Diluted Shares     43.9
December 2007 Equity Offering:
Net Proceeds       $3.6
Common Share Outstanding after offering       41.0
Fully - Diluted Shares      46.7
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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*January 2008
SCOLR Pharma, Inc.
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®
SCOLR Pharma
 Well Positioned for the Future
§ Large, growing markets
§ Unique, broadly applicable, patented technology platform
 with important benefits
§ Expanding prescription and OTC pipeline with multiple
 clinical and pre-clinical candidates
§ Royalty revenues from existing products
§ Value driving milestones
§ Experienced management team
 
 

 
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*January 2008
SCOLR Pharma, Inc.
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