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 August 2006 (v06-n08) - Anniversary Issue
See the complete outline below.
 
This is a special issue of our newsletter. We provide detailed updates on all the companies currently in our coverage universe. Weighing in at 212 pages, its a must-read for anyone interested in development-stage biotech companies. In this issue, we examine all 21 companies in our coverage universe, ranking them from 1st to 21st. This is easily our most popular issue every year, often becoming a tattered "handbook" in the top desk drawer of professional and independent investors.

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If you are interested in one of the companies listed below you cannot miss this issue.

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In addition to updated milestone tables for all companies, we asked each management team the following seven questions:

(1) You are in a room with your peers from the other companies in our coverage universe. The audience will invest in only one company. Give me two or three reasons why it should be your company.

(2) What is the most important strategic decision you’ve made in the last year

(3) What was your most disappointing setback in the last year?

(4) Does any member of the executive team currently have a hedge, collar, or similar position on his/her stock or stock options? If no, is this prohibited? Have you backdated any options grants?

(5) Manufacturing is often a major stumbling block for young companies. How will your company avoid this going forward? What unique risks are posed by your particular manufacturing strategy?

(6) If you look across the entire biotechnology field, what science or technology do you think will make the biggest impact over the next two years?

(7) Looking again across the entire biotech field, what structural (regulatory, marketing, etc.) changes do you see as important over the next two years?

               NOTE: This table of contents is sorted by alphabetical order.          In the actual report, they are ranked on merit from 1-25.

Introduction
Table: BSR Model Portfolio changes
Table: 2006 Anniversary Issue Rankings
Table: 2006/2005 Anniversary Issue Rankings Comparison
Table: 2005 Anniversary Issue Ranking Performance
Adolor (ADLR) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (11 updates since 8/2005)
Disclosure
POI
OBD
Short-term combo trial
Other
Two-in-one pill
Acquisition
Bull Case
Bear Case
Investment Case
Seven Questions
 
BioMarin (BMRN) -- 10 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (19 updates since 8/2005)
Disclosure
Product portfolio
Table: Selected marketed products and lead candidate
Aldurazyme
Table: Net product sales
Naglazyme
Orapred ODT
Table: Orapred financial events
Phenylketonuria program
Phenoptin development program
Other uses for Phenoptin
Table: Serono deal
Bull Case
Bear Case
Investment Case
Seven Questions
 
Corcept (CORT) -- 14 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (11 updates since 8/2005)
Disclosures
 
Introduction
Financials
The cortisol hypothesis
Quick market introduction for psychotic depression
Remission rates
Table: Remission rates for severe depression
Table: Remission rates for psychotic depression
Treating psychotic depression with mifepristone
The recent Phase III results (07 study)
Handicapping the results of the other Phase III studies
Table: Ongoing Corlux pivotal trials
SPA and additional clinical trials
Severe weight gain due to antipsychotic medications
The back door escape route: An Orphan indication
Bull Case
Bear Case
Investment Case
Seven Questions
 
Cortex (AMEX:COR) -- 7 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (13 updates since 8/2005)
Disclosures
Clinical hold
Financials
Quick info on ampakines
Low-impact versus high-impact ampakines
The far future
Strategy
Clinical updates
ADHD
Table: ADHD trial info
Table: Strattera Phase III trials
Table: CX717 pilot trial
Next ADHD study
Alzheimer's Disease
Bull Case
Bear Case
Investment Case
Seven Questions
 
Dendreon (DNDN) -- 10 pages
Table: Timelines
Table: Basic Facts
Table: Publication history (35 updates since 8/2005))
Disclosure
So what are expected sales?
Step One
Step Two
Step Three
It's up to you
BLA
P-11
Pod counts
Neuvenge
GVAX tidbits
Bull Case
Bear Case
Investment Case
Seven Questions
 
Discovery Labs (DSCO) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (30 updates since 8/2005))
Disclosure
 
The crux of the matter... again
Table: Cash considerations
Future highlights
Bull Case
Bear Case
Investment Case
Seven Questions
Dynavax (DVAX) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (1 update since debut 7/2006))
Disclosure
The product science of Dynavax
Table: Selected other TLR companies
Brief introduction
The ideal TLR technology
Why Dynavax?
Dynavax Products
Heplisav
Tolamba
Symphony Dynamo
Bull Case
Bear Case
Investment Case
Seven Questions
 
Forbes Medi-Tech (FMTI) -- 5 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (13 updates since 8/2005)
Disclosures
Utility in the real world
Work still to do
Partnership
Over-the-counter combination
Bull Case
Bear Case
Investment Case
Seven Questions
 
Genta (GNTA) -- 5 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (21 updates since 8/2005)
Disclosures
ODAC on CLL
Why we're not forecasting an outcome
That said (yeah, you knew we couldn't resist)...
What we learned from Marqibo
Melanoma in EU
Bull Case
Bear Case
Investment Case
Seven Questions
 
Hana Biosciences (HNAB) -- 9 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (14 updates since debut 2/2006)
Disclosures
They have a plan
Zensana
The original plan
Unexpected development
Patent worries
Market impact of generic ODT
Partner(s) coming
Marqibo
ODAC failure
Phase III 2+ relapse ALL
Phase III Intergroup elderly ALL study
Treatment mechanics
Talvesta (talotrexin)
IPdR
Bull Case
Bear Case
Investment Case
Seven Questions
 
Indevus (IDEV) -- 10 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (19 updates since 8/2005)
Disclosure
Sanctura XR -- Different this time?
How to sell it
So how do they sell it !?!?!
What about an acquisition?
What if Esprit "PLIVA's" the sales effort?
Bottom line on Sanctura XR
Pagoclone
Stuttering
Premature ejaculation (PE)
Partnering
IP-751
Aminocandin
Nebido
PRO-2000
Bull Case
Bear Case
Investment Case
Seven Questions
Introgen (INGN) -- 4 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (16 updates since 8/2005)
Disclosure
Is it almost over?
BLA inside of 6 months
The latest set of whoppers
Biomarkers
Special Protocol Assessment
Regulatory package
Seriously, though
Bull Case
Bear Case
Investment Case
Seven Questions
 
Medarex (MEDX) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (16 updates since 8/2005)
Disclosures
Stock Options Backdatin
MDX-010 (ipilimumab)
Side effects & Pfizer
MDX-060
MDX-070
MDX-1100
MDX-214
MDX-1106
Partnered targets
CNTO-148 (golimumab and CNTO-1275
HuMax-CD40 & HuMax-20
Acquisition target?
Bull Case
Bear Case
Investment Case
Seven Questions
 
Nabi  (NABI) -- 11 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (15 updates since 8/2005)
Disclosures
Financials
Product highlights
Table: Nabi products on the market
Table: Nabi products in the clinic
The new StaphVAX
The new Altastaph
PhosLo
Nabi-HB
NicVAX
Civacir
ATG-Fresenius S
Shareholder discontent
Bull Case
Bear Case
Investment Case
Seven Questions
 
Neurochem  (NRMX) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (8 updates since debut 12/2005)
Disclosure
Brief Science of Neurochem
Plaques & tangles
The basis for Neurochem's Drugs
Product portfolio
Alzhemed
Table: Phase II Open-label extension increase in ADAS score
Kiacta
Hemorrhagic stroke due to cerebral amyloid angiopathy
Bull Case
Bear Case
Investment Case
Seven Questions
 
Oncolytics Biotech (ONCY) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (13 updates since 8/2005)
Disclosures
Patience, grasshopper
Stream 'o consciousness
Table: Reolysin clinical trials (2 pages)
Bull Case
Bear Case
Investment Case
Seven Questions
 
Praecis (PRCS) -- 3 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (15 updates since debut 1/2006)
Disclosures
Strategic process
Do a dilutive equity offering
Do nothing but cut staff
Sell the company or products
Merge with another company
Bull Case
Bear Case
Investment Case
Seven Questions
 
Repros Therapeutics (RPRX) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (6 updates since debut 2/2005)
Disclosures
Androxal
Table:Androxal Phase IIb endpoints
Proellex
Uterine fibroids
Endometriosis
Manufacturing
End game postponed
Bull Case
Bear Case
Investment Case
Seven Questions
 
SciClone (SCLN) -- 10 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (20 updates since 8/2005)
 
Disclosures
The new CEO
Product profiles
Metastatic melanoma
Table: Top line results
Hepatocellular carcinoma: A footnote
Table: Phase II hepatocellular carcinoma
Hepatitis C
Table: Phase III triple therapy trials - Europe
SCV-07
SciClone, the Chinese company
Financials
DC-Beads
Bull Case
Bear Case
Investment Case
Seven Questions
Seattle Genetics (SGEN) -- 7 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (9 updates since 8/2005)
Disclosures
SGN-30
SGN-40
SGN-33
SGN-35
SGN-70
SGN-75
Partnering and raising cash
Bull Case
Bear Case
Investment Case
Seven Questions
Sonus (SNUS) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (16 updates since 8/2005)
Disclosures
Is Bayer bullish on Sonus?
CALGB license
Manufacturing and pricing
Bull Case
Bear Case
Investment Case
Seven Questions
Targeted Genetics (TGEN) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (7 updates since 8/2005)
Disclosures
What has gone before
Ancient history
Next steps?
Conclusion
tgAAC-94 (RA)
Target market
Wrapping up
tgAAC-09 (HIV)
Manufacturing
Celladon
SiRNA
Bull Case
Bear Case
Investment Case
Seven Questions
ViRexx (REX) -- 4 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (4 updates since debut 3/2005)
Disclosures
Achilles and his heel
Product portfolio
Antibody-based immunotherapy (AIT)
Table:ViRexx therapeutic platforms
Table: AIT Platform partners
Chimigen
Occlusion products (T-ACT platform)
Bull Case
Bear Case
Investment Case
Seven Questions
 
YM Biosciences (YMI) -- 4 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (26 updates since debut 11/2005)
Disclosures
Regulatory and manufacturing
Tesmilifene partner
DEC trial statistics
Table: Conditional probability of futility
So what do we think is going on?
Nimotuzumab
Cautionary tale
Bull Case
Bear Case
Investment Case
Seven Questions
ZymoGenetics (ZGEN) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (12 updates since 8/2005)
Disclosures
rhThrombin
Atacicept (TACI-ig)
B-cell lymphomas
Lupus
Rheumatoid arthritis
Partner
IL-21
IL-29
Other items
Bull Case
Bear Case
Investment Case
Seven Questions
 
Macro Market Commentary
Obvious clouds, less obvious is the color of their lining
 
Biotech Sector Short Interest
Chart: NASDAQ Biotech Index (NBI) short interest (indexed)
Chart: NBI short interest as a percentage of total NASDAQ short interest
Table: Top 15 NBI shorted companies as a percentage of float

BSR Model Portfolio Performance

 
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