Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Reorganized to increase clarity and hopefully make it easier for
readers to find a given item. New or revised entries for the following:

Corporate/financial
liquidity and cash usage (updated for 2Q10 financials);
transcript from 2Q10 CC;
$5M milestone from NVS for FDA approval is separate from potential $163M;
MNTA’s reimbursement of NVS for Lovenox development expenses;
valuation musings by tinkershaw;
recent patent applications;
revised table of insider shareholdings;
tax rationale for recent insider selling;

Lovenox program
Sanford Bernstein’s dubious 8/5/10 rumor about Teva;
SNY appears to rule out an AG in near future;
NVS can supply 35-40% of Lovenox market at launch;
60-70% of Lovenox market is hospital-based;
musings on gross margin of generic Lovenox;
musings by several posters on likelihood of Teva’s obtaining FDA approval for Lovenox;
EU requirements for a Lovenox biosimilar and related musings;
new version of “What’s New in the Anticoagulant Market”;

Copaxone program
Teva’s Copaxone patents can be attacked on multiple fronts;
FDA might grant bioequivalence waiver for generic Copaxone;
relatively unattractive ex-US market for generic Copaxone;
interview with Sandoz CEO re generic Copaxone.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-25473104 Capsule summary of proprietary technology
#msg-52632000 ‘The Golden Age of Biogenerics’ (Forbes)
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-52891502 Transcript from 2Q10 conference call
#msg-53076761 Recent patent applications and overview of IP estate


News flow
#msg-52678515 2010-2011 possible/probable news flow


Valuation and finances
#msg-52864485 Liquidity and cash usage
#msg-52863330 2Q10 financial results
#msg-44687884 Potential Lovenox/Copaxone milestones = $163M
#msg-52863951 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-42163809 Diluted share count for valuation purposes
#msg-44367437 Shelf registration filed 12/9/09
#msg-41777300 Latest financing transaction
#msg-52613313 Valuation musings by ThomasS
#msg-52899885 Valuation musings by tinkershaw


Management, BoD, and major shareholders
#msg-51595947 Composition of Board of Directors
#msg-38645684 Bruce Downey, ex-CEO of Barr, joins BoD
#msg-12824293 Craig Wheeler named CEO (Aug 2006)
#msg-33979910 James Sulat named Chairman (Dec 2008)
#msg-27338039 James Roach named CMO (Feb 2008)
#msg-49501257 How MNTA executed against 2009 goals
#msg-53028901 Insider shareholdings and options
#msg-53029172 Tax rationale for recent insider selling
#msg-51596206 Major shareholders
#msg-47147018 No legal impediments to an acquisition



LOVENOX PROGRAM

FDA approval and related litigation
#msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR)
#msg-52578102 FDA approves NVS/MNTA’s generic Lovenox (MNTA PR)
#msg-53055913 Link to FDA webpage on generic Lovenox
#msg-52582225 Why FDA approved generic Lovenox (simple version)
#msg-52581746 Why FDA approved generic Lovenox (45-page technical version)
#msg-52672381 Sanofi’s ‘Hail Mary’ lawsuit against FDA
#msg-29282002 End of the line for Sanofi’s Lovenox patent (May 2008)


Economic rationale and profit split in US market
(See related section below on potential competition from other Lovenox generics.)
#msg-52759766 Lovenox sells $4.5B/yr, 60% in US
#msg-52869916 NVS can supply 35-40% of Lovenox market at launch
#msg-52936910 Musings on gross margin of generic Lovenox
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-52868377 MNTA to reimburse NVS for portion of development costs
#msg-53024492 Addendum re MNTA’s reimbursement obligation
#msg-53022548 zipjet’s estimate of MNTA’s reimbursement obligation
#msg-52651605 Generic priced at small discount to branded product
#msg-52652888 Musings on pricing decision (zipjet)
#msg-44687884 Potential milestone payments of $163M
#msg-52863951 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-52792105 MNTA royalty payable to MIT
#msg-41482908 Lovenox is not at all like Omnitrope
#msg-43761160 Lovenox royalty if multiple generics
#msg-46578876 How would MNTA be affected by a Sanofi AG?
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-52871590 60-70% of Lovenox market is hospital-based
#msg-28936334 Proportion of Lovenox sales in various indications


Potential Lovenox US generics from other companies
#msg-52999229 Sanford Bernstein’s dubious rumor causes MNTA sell-off
#msg-52761665 SNY appears to rule out Lovenox AG in near future
#msg-38906603 Musings on likelihood of an AG
#msg-45522123 Teva’s disinformation re Lovenox characterization
#msg-52589074 Teva’s sour grapes PR on losing out to MNTA
#msg-53070505 Musings on a Teva approval (ThomasS)
#msg-53090148 Musings on a Teva approval (oc631)
#msg-52985447 Musings on a Teva approval (tinkershaw)(1)
#msg-53026617 Musings on a Teva approval (tinkershaw)(2)
#msg-52974802 Musings on a Teva approval (biomaven)
#msg-53053911 Musings on a Teva approval (RockRat)
#msg-52894756 Musings on a Teva approval (zipjet)(1)
#msg-52842458 Musings on a Teva approval (zipjet)(2)
#msg-43206942 Possibility of a non-substitutable generic by Teva
#msg-46994189 The sorry state of Amphastar’s application (1)
#msg-52924781 The sorry state of Amphastar’s application (2)
#msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint


Lovenox competition from other anticoagulants
#msg-52988021 What’s new in the anticoagulant market?
#msg-40342721 Why Arixtra is inconsequential to MNTA
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS


Lovenox biosimilar program in EU
#msg-12222305 Lovenox in EU falls under 2006 NVS-MNTA agreement
#msg-52625998 EU requirements for Lovenox biosimilar and related musings
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-28936334 Proportion of Lovenox sales in various indications



COPAXONE PROGRAM

FDA application
#msg-30621490 FDA accepts NVS/MNTA ANDA for review
#msg-48167251 Will Copaxone ANDA require clinical trials?
#msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call
#msg-52599384 When can FDA approve MNTA’s Copaxone?
#msg-30938608 MNTA/NVS have Hatch-Waxman first-filer status
#msg-50163309 Link to FDA rejection of Teva’s Citizen Petition
#msg-50113814 Leerink Swann on rejection of Teva’s Citizen Petition (1)
#msg-50149604 Leerink Swann on rejection of Teva’s Citizen Petition (2)
#msg-50185042 Musings on Teva’s CP rejection from BioWorld Today
#msg-30647865 “Controlled chaos” and reverse engineering
#msg-48166546 Teva’s disinformation campaign (10^28 permutations)
#msg-52577893 Copaxone is easier to characterize than Lovenox (IMO)
#msg-48127583 Bullish musings on regulatory outlook (dewophile)
#msg-48145473 Bearish musings on regulatory outlook (genisi)
#msg-52702351 FDA might grant bioequivalence waiver
#msg-52589866 Why Teva’s stock was hammered on 7/23/10


Economic rationale and profit split
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-52673284 US Copaxone sales are $2.1B per annum
#msg-44687884 Potential milestone payments are $163M
#msg-52863951 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-53081150 Ex-US market for generic Copaxone not especially attractive


Patent litigation
#msg-52735648 Teva’s patents can be attacked on multiple fronts
#msg-30960930 List of Copaxone Orange Book patents being challenged
#msg-44092062 Court bars Teva from adding patents to litigation


Potential competition from other generic and branded drugs
#msg-29902618 FDA to review Mylan/Natco ANDA (1)
#msg-52598947 FDA to review Mylan/Natco ANDA (2)
#msg-52553991 Copaxone should hold its own against new entrants
#msg-36015642 FDA approves Copaxone for CIS
#msg-50939364 Teva’s ‘low-volume’ Copaxone (PR and comments)
#msg-51123550 Musings on low-volume Copaxone from MNTA annual meeting
#msg-52673284 Copaxone is cleaning Tysabri’s clock in US market
#msg-41292688 Tysabri’s 3-year PML rate
#msg-39971611 US market share of MS drugs (2Q09)
#msg-35060588 Comparative efficacy of approved MS drugs
#msg-37325525 MS drugs in phase-2 or phase-3
#msg-31553565 Musings on MS drugs in development (genisi)
#msg-52012641 Musings on Gilenia by ‘neuroinv’
#msg-51168875 FDA panel unanimously backs Gilenia
#msg-48971681 Campath 4-year phase-2 data from 2010 AAN
#msg-34832939 Musings on Campath (with another table of MS drugs)
#msg-34865448 NVS takes option on Peptimmune’s PI-2301
#msg-52714348 FDA grants priority review for Cladribine
#msg-39934109 Dirucotide from BioMS fails—program terminated



OTHER R&D PROGRAMS

M118 proprietary-anticoagulant program
#msg-39146357 M118 quick primer
#msg-51227061 How large is the anticoagulant market?
#msg-26898084 Cartoon: How M118 binds to FIIa and FXa
#msg-31027378 M118 has no drug interaction with aspirin or Plavix…
#msg-31029674 …but Lovenox does (i.e. advantage: M118)
#msg-41846746 Data from phase-2a EMINENCE study
#msg-48837450 Non-inferiority analysis from EMINENCE study
#msg-48837695 Kaplan-Meier curves from EMINENCE study
#msg-31057367 Phase-1 results with subcutaneous formulation
#msg-48837475 What are MNTA’s goals for M118?
#msg-50887745 Musings on the relevance of PolyMedix’s PMX-60056
#msg-41897705 Musings on M118 differentiation in the ACS market
#msg-47474349 Why an M118 partnership has taken so long
#msg-39180621 M118 is not ‘Recothrom Part Deux’
#msg-48705801 Apr 2010 paper in Circulation
#msg-48815510 Review of Circulation paper by TCTMD
#msg-43301340 Nov 2009 paper in Thrombosis and Hemostasis
#msg-27272430 Feb 2008 paper in Blood
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS


M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-49143958 Preclinical data from 2010 AACR
#msg-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 AACR


FoB program
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-48581353 What the new healthcare law says about FoB’s
#msg-26837144 Momenta’s mantra on biogenerics
#msg-44688351 Why M178 was dropped
#msg-52853238 Speculation re Orencia FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena



PUBLICATIONS

#msg-48115945 Weizmann Institute re chemistry of Copaxone (date unknown)
#msg-52862494 Globes online (Israel) interview with Sandoz CEO (8/10)
#msg-52632000 Forbes re ‘The Golden Age of Biogenerics’ (7/10)
#msg-52606143 NY Times re FDA approval (7/10)
#msg-25160571 WSJ re anticoagulant market (12/07)
#msg-23005127 Nature re FoB’s (9/07)
#msg-20308884 Lab Technologist re production process (6/07)
#msg-25803923 The Pink Sheet interview with C. Wheeler (3/07)
#msg-7370282 WSJ re MNTA’s raison d’etre (8/05)
#msg-25779774 Boston Globe re MNTA’s IPO (11/04)
#msg-33867074 Signals Magazine re glycobiology (9/03)