Replies to post #8492 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTCB ReadMeFirst

[Updated for 4Q07 financial results and Protexia news.]


What is GTC’s business all about?
#msg-19391437 What is the business model?
#msg-27114674 GTC’s role in Follow-On Biologics
#msg-22016210 Musings on GTC’s business-model risk
#msg-11752181 ATryn HD program in EU is proof of concept
#msg-9243634 Jan 2006 interview with CEO, Geoff Cox
#msg-9352093 2002 interview with Tom Newberry (dated but informative)
#msg-13171505 Technical paper on the science of transgenics


Valuation and finances
#msg-26650518 Latest financing transaction
#msg-27389551 4Q07 results
#msg-27389749 Cash balance and expected cash burn
#msg-27389861 Notes on “going concern” qualification
#msg-26658455 Share count for valuation purposes
#msg-22017312 Projected ATryn sales are >$1B
#msg-27221505 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-25908563 How to value GTC’s net-loss carryforward
#msg-25377457 Hostile takeover highly unlikely


News flow
#msg-26874681 Possible/probable events in 2008-2009
#msg-26883055 Clinical, preclinical goals in 2008-2009


Management and BoD
#msg-25257085 Composition of Board of Directors
#msg-25610590 Current insider holdings
#msg-25370967 Recent insider transactions
#msg-26840492 Largest shareholders


ATryn hereditary-deficiency program in Europe
#msg-24802503 Leo PR on ATryn launch in UK
#msg-11752181 ATryn HD program in EU is proof of concept
#msg-12430822 Economics of the Leo partnership
#msg-27253453 Musings on the ATryn price
#msg-24709713 Official UK product specs
#msg-20873099 Sales projection for HD indication in EU
#msg-8316050 Leo Pharma partnership announcement
#msg-26883688 What is hereditary AT deficiency? (chase link at bottom)
#msg-9502819 A patient’s story
#msg-26144771 Official EMEA Documents on ATryn in HD


ATryn hereditary-deficiency program in US
#msg-26535139 Phase-3 study meets primary endpoint
#msg-27081539 Last (17th) patient enrolled
#msg-26569418 US ATryn timeline
#msg-25164757 FDA grants ATryn an Orphan Drug designation
#msg-25173071 Significance of the orphan designation
#msg-27253453 Musings on the ATryn price
#msg-24751863 Sales projections for HD indication
#msg-20966468 Plasma-derived AT in U.S. is in short supply
#msg-23864419 Risks/supply constraints of plasma-derived drugs
#msg-25943427 Survey results on the US partnership
#msg-25943427 Speculation on the US partner


ATryn DIC/sepsis program
DIC summary from GTC’s website
#msg-22017312 Large addressable market (1)
#msg-25873575 Large addressable market (2)
#msg-26910150 Large addressable market (3)
#msg-25222553 Existing therapeutic option (Xigris) is weak
#msg-25214176 Scientific rationale for program (summary)
#msg-26145421 Scientific rationale for program (detailed)
#msg-12430822 Economics of the Leo partnership
#msg-21636676 Details of Leo’s phase-2 trial
#msg-25154549 Musings by dewophile
#msg-26123066 Musings by Dew
#msg-25154486 How sepsis causes DIC (detailed, for science nerds only!)
#msg-27219642 How sepsis causes DIC (simplified view)
#msg-27253453 Musings on the ATryn price
#msg-25325852 Rough DIC timeline
#msg-14495208 When will GTC receive milestone payments?


Miscellaneous info on antithrombin
#msg-27280453 Auxiliary reference list of antithrombin papers


GTC-LFB program in Factor VIIa
Who is LFB?
#msg-13956439 Who is LFB? (addendum)
#msg-13708619 Partnership terms
#msg-15247168 How the collaboration works
#msg-27139814 Pharmacoeconomic rationale for FVIIa program
#msg-26456856 FVIIa has blockbuster sales already…
#msg-26909638 …and even larger sales are forecasted
#msg-14084250 FDA approves NovoSeven in acquired hemophilia
#msg-13763244 Patient pool for initial indication
#msg-27280690 Reference list of FVIIa papers


Alpha-1 antitrypsin program
#msg-26909835 Rationale for AAT program
#msg-22581060 Quick read on AAT deficiency
#msg-15170172 More background on AAT deficiency
#msg-24192571 Musings on orphan-drug exclusivity


Miscellaneous internal and external programs
#msg-26883499 GTC’s drug portfolio
Capsule summaries of internal programs
#msg-25039843 ProGenetics collaboration
#msg-25875091 LFB joins Factor IX program
#msg-26569733 Merrimack’s MM-093
#msg-27391081 PharmAthene’s Protexia
#msg-26909850 Rationale for CD137 program
#msg-13797351 SBIR grant for CD137 program
#msg-21754646 CD20 (Rituxan FoB) program


Intellectual property
#msg-22560060 “Milk” patent
#msg-7179529 Purification patent
#msg-27143367 Pending patent applications
#msg-18949245 IP summary from most recent 10K report
#msg-25410579 Musings on fibrinogen IP
#msg-18615705 Nuclear-transfer license from Geron
#msg-19226707 Notes on nuclear-transfer license


Existing and potential competition
(See GTC-LFB heading above for NovoSeven™ brand rFVIIa)

Plasma-derived products:
#msg-23864419 Risks/supply constraints of plasma-derived drugs
#msg-11909951 Thrombate AT from Talecris
#msg-15898317 AT from Grifols
#msg-27011864 Prolastin AAT from Talecris
#msg-27079832 Kamada’s injected and inhaled AAT programs
http://alpha1health.com Aralast AAT from Baxter
#msg-6488263 AAT from Purely Proteins (market-size info)

Non-transgenic recombinant products:
#msg-27043616 ART-123 from Artisan Pharma
#msg-25222553 Xigris
#msg-15157973 Tifacogin for CAP/sepsis from NVS
#msg-27187973 Paion’s Solulin (thrombomodulin)
#msg-14176380 AM-Pharma program in sepsis
#msg-26162978 AZN/Protherics program in sepsis
#msg-22562453 Miscellaneous competition in DIC/sepsis
#msg-27193231 Arriva inhaled AAT program
#msg-25259635 FVIIa analogues from Novo Nordisk
#msg-19911920 Maxygen’s Maxy-Seven
#msg-25188594 CSL’s albumin-FVIIa conjugate
#msg-25800123 Baxter Factor IX programs
#msg-25447561 Baxter-NKTR pegylated clotting factors
#msg-15573025 Baxter-Lipoxen clotting factors
#msg-15983905 Factor IX-Fc from Biovitrum / BIIB
#msg-22076906 Factor V Leiden from CRXL
#msg-21761579 Second-generation CD20 program from DNA/BIIB
#msg-24683024 HuMax-CD20 from GSK/Genmab
#msg-21863730 CD20 program from InNexus Biotechnology
#msg-25325807 Overview of CD20 programs (20-min video)
#msg-27286294 BioWa / Kyowa Hakko
#msg-24264196 Protalix
#msg-20143313 Novozymes
#msg-21123960 Inspiration Biopharmaceuticals
http://greenovation.com Greenovation

Products derived from transgenic animals:
#msg-23381254 Origen (polyclonal Ab’s from chicken eggs)
#msg-16835174 Technical issues with transgenic chickens
#msg-18396260 Roche (polyclonal Ab’s from animal serum)
#msg-15899425 Kirin / Hematech

Products derived from transgenic plants:
#msg-24872146 Risks of plant-based platforms
#msg-26569811 Biolex (CD20 program)
#msg-15925882 SemBioSys
#msg-14191540 Prairie Plant Systems

Miscellaneous:
#msg-21040065 Major FoB players
#msg-26911313 ATryn vs FXa inhibitors
#msg-24140012 Lovenox doesn’t work for AT HD
#msg-13169472 GlycoFi/Merck (humanized yeast glycosylation)
#msg-13222976 More on the GlycoFi story
#msg-21530514 DSM/Crucell antibody-production platform
#msg-20702138 Penn State’s mushrooms


Feature stories on GTCB and transgenics
#msg-23866167 Contract Pharma (10/07)
#msg-23359755 BioWorld International profiles LFB (10/07)
#msg-19726180 BioPharma Reporter (5/07)
#msg-17042733 Wired (2/07)
#msg-15920370 Managed Care (11/06)
#msg-13365243 Times of London (9/06)
#msg-13152292 Nature.com (9/06)
#msg-14278650 Biotechnology Healthcare (8/06)
#msg-12573463 Nature Biotechnology (8/06)
#msg-12273566 Boston Globe profiles Dr. Harry Meade (7/06)
#msg-11635041 Framingham, Mass. Daily News (6/06)